Fraxiparine tablets instructions for use. Fraxiparine: instructions for use. High risk of blood clots

• Instructions for use Fraxiparin
• Composition of the drug Fraxiparine
• Indications for the drug Fraxiparine
• Storage conditions for the drug Fraxiparine
• Shelf life of the drug Fraxiparine

Release form, composition and packaging

Injection

Excipients: calcium hydroxide solution or dilute hydrochloric acid to pH 5-7.5 to pH 5.0-7.5, water for up to 0.6 ml.

0.6 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

Injection transparent or slightly opalescent, colorless or light yellow.

Excipients: calcium hydroxide solution or dilute hydrochloric acid to pH 5-7.5 to pH 5.0-7.5, water for up to 0.8 ml.

0.8 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

Description of the drug FRAXIPARINE based on officially approved instructions for use of the drug and made in 2007. Update date: 02/26/2007

pharmachologic effect

Nadroparin calcium is a low molecular weight heparin (LMWH) obtained by depolymerization from standard heparin. It is a glycosaminoglycan with an average molecular weight of 4300 daltons.

Shows a high ability to bind to the plasma protein antithrombin III (ATIII). This binding leads to accelerated inhibition of factor Xa, which is responsible for the high antithrombotic potential of nadroparin. Nadroparin calcium is characterized by higher anti-Xa factor activity compared to anti-IIa factor or antithrombotic activity.

Other mechanisms mediating the antithrombotic activity of nadroparin include stimulation of tissue factor pathway inhibitor (TFPI), activation of fibrinolysis through direct release of tissue plasminogen activator from endothelial cells, and modification of blood rheology (decreased blood viscosity and increased platelet and granulocyte membrane permeability).

Nadroparin is a low molecular weight heparin, in which the antithrombotic and anticoagulant properties of standard heparin are separated, and is characterized by higher activity against factor Xa compared to activity against factor IIa. It has both immediate and prolonged antithrombotic activity. The ratio between these types of activity for nadroparin calcium is in the range of 2.5-4.

Compared with unfractionated heparin, nadroparin has less effect on platelet function and aggregation and has little effect on primary hemostasis.

In prophylactic doses, nadroparin does not cause a significant decrease in activated partial thrombin time (aPTT).

During a course of treatment during the period of maximum activity, it is possible to increase the aPTT to a value 1.4 times higher than the standard one. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.

Pharmacokinetics

Pharmacokinetic properties are determined based on changes in anti-Xa factor activity of plasma.

Suction

After subcutaneous administration, absorption is almost 100%. Cmax in blood plasma is reached between 3 and 5 hours.

When using nadroparin calcium in a regimen of 1 injection/day, Cmax is achieved between 4 and 6 hours after administration.

Metabolism

Metabolized mainly in the liver by desulfation and depolymerization.

Removal

After subcutaneous administration, T1/2 of anti-Xa factor activity is 3-4 hours. When low molecular weight heparins are used, anti-IIa factor activity disappears from the plasma faster than anti-Xa factor activity. Anti-Xa factor activity appears within 18 hours after administration of the drug.

It is excreted primarily by the kidneys unchanged or in the form of metabolites that differ little from the unchanged substance.

Pharmacokinetics in special clinical situations

In elderly patients, due to physiological deterioration of renal function, elimination slows down. When using the drug for prophylactic purposes in this category of patients, no change in dosage regimen is required in case of mild renal dysfunction.

Before starting treatment with LMWH (low molecular weight heparin), renal function should be systematically assessed in elderly patients over the age of 75 years using the Cockroft formula.

In persons with renal failure severe, with subcutaneous administration of nadroparin T1/2 is extended to 6 hours, and therefore nadroparin is contraindicated for the treatment of such patients. When using nadroparin in prophylactic doses in this category of patients, the dose should be reduced by 25%.

In patients with moderate renal failure (creatinine clearance more than 30 ml/min), in some cases it is advisable to monitor the level of anti-Xa factor activity in the blood to exclude the possibility of overdose during a course of drug use. In this category of patients, accumulation of nadroparin may occur, and therefore in such patients the dose of nadroparin should be reduced by 25% in the treatment of thromboembolism, unstable angina and myocardial infarction without a pathological Q wave. In this category of patients receiving nadroparin for the prevention of thromboembolic complications, the content Nadroparin does not exceed that in patients with normal renal function taking therapeutic doses of nadroparin. Therefore, a reduction in the dose of nadroparin taken for prophylactic purposes is not required in this category of patients.

During hemodialysis, administration of low molecular weight heparin high doses into the arterial line of the loop of the dialysis system (in order to prevent blood clotting in the loop) does not cause changes in pharmacokinetic parameters, except in the case of overdose, when penetration of the drug into the systemic circulation can lead to an increase in anti-Xa factor activity associated with the final phase of renal failure.

Indications for use

• prevention of thrombus formation during surgical and orthopedic interventions;
• prevention of blood clotting in the extracorporeal circulation system during hemodialysis or hemofiltration;
• prevention of thromboembolic complications in patients with high risk thrombus formation (in acute respiratory and/or heart failure in ICU conditions);
• treatment of thromboembolism;
• treatment of unstable angina and myocardial infarction without a pathological Q wave on the ECG.

Dosage regimen

The drug is administered subcutaneously (except for use during hemodialysis). This dosage form is intended for adults. The drug is not administered intramuscularly. 1 ml of Fraxiparine is equivalent to approximately 9500 IU of the anti-Xa factor activity of nadroparin calcium.

Prevention of thromboembolism in surgery

The frequency of use of the drug is 1 injection/day.

The dose is determined by the degree of risk of thromboembolism in a specific clinical situation and depends on the patient’s body weight and the type of operation.

At moderate thrombogenic risk, as well as in patients no increased risk of thromboembolism effective prevention thromboembolic disease is achieved by administering the drug at a dose of 2850 IU/day (0.3 ml). The initial injection is administered 2 hours before surgery, then nadroparin is administered 1 time/day. Treatment is continued for at least 7 days and during the period of risk of thrombosis until the patient is transferred to an outpatient regimen.

At increased thrombogenic risk (hip and knee surgeries) the dose of Fraxiparine depends on the patient’s body weight. The drug is administered at a dose of 38 IU/kg before surgery, i.e. 12 hours before the procedure, then after the operation, i.e. starting 12 hours after the end of the procedure, then 1 time per day until 3 days after the operation inclusive. Then, starting from the 4th day after surgery, 1 time/day at a dose of 57 IU/kg during the period of risk of thrombosis until the patient is transferred to an outpatient regimen. Minimum duration - 10 days.

When prescribing the drug to non-surgical patients with a high risk of thrombosis, usually in intensive care units (with respiratory failure and/or infections respiratory tract and/or heart failure), the dose of nadroparin depends on the patient’s body weight and is indicated in the table below. The drug is administered 1 time/day. Nadroparin is used throughout the entire period of risk of thrombosis.

In cases where the risk of thromboembolism associated with the type of operation (especially oncological operations) and/or with the individual characteristics of the patient (especially with a history of thromboembolic disease) appears to be increased, a dose of 2850 IU (0.3 ml) may be sufficient, but the dose should be adjusted individually.

Duration of treatment. Treatment with Fraxiparine in combination with traditional elastic compression techniques lower limbs should be continued until complete recovery motor activity sick. IN general surgery The duration of use of Fraxiparine is up to 10 days in the absence of a particular risk of venous thromboembolism associated with the individual characteristics of the patient. If the risk of thromboembolic complications is present after the recommended period of treatment, it is necessary to continue preventive treatment, primarily with oral anticoagulants.

However, the clinical effectiveness of long-term treatment with low molecular weight heparins or vitamin antagonists has not yet been determined.

Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis

Fraxiparine should be administered intravascularly into the arterial shunt of the dialysis loop.

U patients receiving repeated hemodialysis sessions, prevention of coagulation in an extracorporeal purification loop is achieved by administering an initial dose of 65 IU/kg into the arterial line of the dialysis loop at the beginning of the session.

This dose, administered as a single intravascular bolus injection, is only suitable for dialysis sessions lasting no more than 4 hours. Subsequently, the dose can be adjusted depending on the individual response of the patient, which varies greatly.

Doses of the drug depending on body weight are presented in the table.

If necessary, the dose can be changed in accordance with the specific clinical situation and the technical conditions of dialysis. In patients with an increased risk of bleeding, dialysis sessions can be performed by reducing the dose of the drug by 2 times.

Treatment of deep vein thrombosis (DVT)

Any suspicion of deep vein thrombosis should be immediately confirmed by the results of appropriate tests.

The frequency of use of the drug is 2 injections/day with an interval of 12 hours.

A single dose of Fraxiparine is 85 IU/kg.

The dose of Fraxiparine depending on body weight in patients weighing more than 100 kg or less than 40 kg has not been determined. In patients weighing more than 100 kg, the effectiveness of LMWH may be reduced. On the other hand, in patients weighing less than 40 kg, the risk of bleeding may be increased. In such cases, special clinical monitoring is required.

Duration of treatment. Treatment with LMWH should be promptly replaced with oral anticoagulants unless the latter are contraindicated. The duration of treatment with LMWH should not exceed 10 days, including the period of transition to vitamin K antagonists, except in cases where difficulties arise in stabilizing INR. Therefore, treatment with oral anticoagulants should be started as early as possible.

Treatment of unstable angina/myocardial infarction without pathological Q wave on ECG

Fraxiparine is administered subcutaneously at 86 IU/kg 2 times a day (with an interval of 12 hours) in combination with acetylsalicylic acid(recommended oral doses of 75-325 mg after an introductory minimum dose of 160 mg).

An initial dose of 86 IU/kg is administered intravenously as a bolus - then in the same dose subcutaneously. The recommended duration of treatment is 6 days until the patient's condition stabilizes.

Doses of Fraxiparine depending on body weight are presented in the table.

For prevention of thrombosis at patients with moderate renal failure (creatinine clearance ≥ 30 ml/min and< 60 мл/мин) no dose reduction is required. U patients with severe renal failure (SC< 30 мл/мин) the dose should be reduced by 25%.

At treatment of thromboembolism, unstable angina and myocardial infarction without pathological Q wave at patients with renal mild insufficiency and moderate severity the dose should be reduced by 25%. Nadroparin is contraindicated patients with severe renal failure.

Rules for administering the drug

It is preferable to inject with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral abdominal girdle, alternately from the right and left sides. Injection into the thigh is allowed.

To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, and not at an angle, into the pinched fold of skin, held between the thumb and index finger until the end of the solution. Do not rub the injection site after injection. Graduated syringes are designed to select the dose depending on the patient’s body weight.

After administering the drug, you should use the syringe needle protection system:

• holding the used syringe in one hand by the protective housing, pull the holder with the other hand to release the latch and slide the cover to protect the needle until it clicks. The used needle is completely protected.

Side effects

Local reactions: often - the formation of a small subcutaneous hematoma at the injection site;

From the blood coagulation system: when using the drug in high doses, bleeding of various locations is possible (in patients with other risk factors).

From the hematopoietic system:

• when used in high doses - mild thrombocytopenia (type I), which usually disappears with further therapy;
• very rarely - eosinophilia (reversible after discontinuation of the drug);
• in some cases - immune thrombocytopenia(type II), combined with arterial and/or venous thrombosis or thromboembolism.

Others: temporary moderate increase in the activity of liver enzymes (ALT, AST);

Contraindications for use

• signs of bleeding or increased risk of bleeding associated with impaired hemostasis, with the exception of DIC not caused by heparin;
• organic lesions of organs with a tendency to bleed (for example, acute stomach ulcer or duodenum);
• injuries or surgical interventions on the central nervous system;
• septic endocarditis;
• intracranial hemorrhages;
• severe renal failure (CK< 30 мл/мин);
• hypersensitivity to the components of the drug;
• history of hypersensitivity to other low molecular weight heparins and/or heparin.

special instructions

Overdose

Symptoms: with subcutaneous administration in high doses - bleeding. In the case of oral administration of even an excessive dose of LMWH, serious problems are still unlikely due to the very low absorption of the drug.

Treatment: for minor bleeding, it is usually sufficient to delay administration next dose drug. Platelet counts and other blood clotting parameters should be monitored.

In some cases, the use of protamine sulfate is indicated, but it should be borne in mind that its effectiveness is significantly lower than with an overdose of unfractionated heparin. The benefit/risk of protamine sulfate should be carefully assessed due to its side effects(especially the risk of developing anaphylactic shock). If a decision is made to use protamine sulfate, it should be administered intravenously slowly. Its effective dose depends on the administered dose of heparin (protamine sulfate at a dose of 100 antiheparin units is used to neutralize 100 IU of anti-Xa factor activity of LMWH), the time elapsed after heparin administration (with a possible reduction in the dose of the antidote). However, it is impossible to completely neutralize anti-Xa factor activity. Moreover, the absorption characteristics of LMWH determine the temporary nature of the neutralizing effect of protamine sulfate; therefore, it may be necessary to divide its dose into several injections (2-4) during the day.

Drug interactions

The risk of developing hyperkalemia increases when using Fraxiparine in patients receiving potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim.

Fraxiparine can potentiate the effect of drugs that affect hemostasis, such as acetylsalicylic acid and other NSAIDs, vitamin K antagonists, fibrinolytics and dextran, which leads to a mutually enhanced effect.

Platelet aggregation inhibitors (except for acetylsalicylic acid as an analgesic and antipyretic drug, i.e. in a dose of more than 500 mg; NSAIDs):

• abciximab, acetylsalicylic acid as an antiplatelet agent (i.e., at a dose of 50-300 mg) for cardiac and neurological indications, beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban increase the risk of bleeding.

Contacts for inquiries

GlaxoSmithKline, representative office, (Great Britain)



Representation
OOO " GlaxoSmithKline Export Ltd"
in the Republic of Belarus

Active substance

Nadroparin calcium

Release form, composition and packaging

Solution for subcutaneous administration

Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.3 ml).

0.3 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.3 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

Solution for subcutaneous administration transparent, slightly opalescent, colorless or light yellow.

Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.4 ml).

0.4 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.4 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

Solution for subcutaneous administration transparent, slightly opalescent, colorless or light yellow.

Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.6 ml).

0.6 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.6 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

Solution for subcutaneous administration transparent, slightly opalescent, colorless or light yellow.

Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.8 ml).

0.8 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.8 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

Solution for subcutaneous administration transparent, slightly opalescent, colorless or light yellow.

Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 1 ml).

1 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
1 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

pharmachologic effect

Nadroparin calcium is a low molecular weight (LMWH) obtained by depolymerization from standard heparin, is a glycosaminoglycan with an average molecular weight of 4300 daltons.

Shows a high ability to bind to the blood protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which accounts for the high antithrombotic potential of nadroparin.

Other mechanisms mediating the antithrombotic effect of nadroparin include activation of tissue factor converting inhibitor (TFPI), activation of fibrinolysis through direct release of tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (decreasing blood viscosity and increasing platelet and granulocyte membrane permeability).

Nadroparin calcium is characterized by higher anti-Xa factor activity compared to anti-IIa factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity.

Compared with unfractionated heparin, nadroparin has a lesser effect on platelet function and aggregation and a less pronounced effect on primary hemostasis.

In prophylactic doses, nadroparin does not cause a significant decrease in aPTT.

During a course of treatment during the period of maximum activity, it is possible to increase the aPTT to a value 1.4 times higher than the standard one. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.

Pharmacokinetics

Pharmacokinetic properties are determined based on changes in anti-Xa factor activity of plasma.

Suction

After subcutaneous administration, maximum anti-Xa activity (Cmax) is achieved after 3-5 hours, nadroparin is absorbed almost completely (about 88%). With intravenous administration, maximum anti-Xa activity is achieved in less than 10 minutes, T1/2 is about 2 hours.

Metabolism

Metabolized mainly in the liver by desulfation and depolymerization.

Removal

After subcutaneous administration, T1/2 is about 3.5 hours. However, anti-Xa activity persists for at least 18 hours after injection of nadroparin at a dose of 1900 anti-Xa ME.

Pharmacokinetics in special clinical situations

In elderly patients, due to physiological deterioration of renal function, the elimination of nadroparin slows down. Possible renal failure in this group of patients requires evaluation and appropriate dose adjustment.

In clinical studies to study the pharmacokinetics of nadroparin when administered intravenously to patients with renal failure varying degrees severity, a correlation was established between the clearance of nadroparin and the clearance of creatinine. When comparing the obtained values ​​with those in healthy volunteers, it was found that AUC and T1/2 in patients with renal failure mild degree(Cl 36-43 ml/min) were increased to 52% and 39%, respectively, and plasma clearance of nadroparin was reduced to 63% of normal values. In patients with severe renal failure (creatinine clearance 10-20 ml/min), AUC and T1/2 were increased to 95% and 112%, respectively, and plasma clearance of nadroparin was reduced to 50% of normal values. In patients with severe renal failure (creatinine clearance 3-6 ml/min) and on hemodialysis, AUC and T1/2 were increased to 62% and 65%, respectively, and plasma clearance of nadroparin was reduced to 67% of normal values.

The results of the study showed that a slight accumulation of nadroparin may be observed in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min and< 60 мл/мин). Следовательно, дозу Фраксипарина следует уменьшить на 25% у пациентов, получающих Фраксипарин с целью лечения тромбоэмболии, нестабильной стенокардии/инфаркта миокарда без зубца Q. Пациентам с почечной недостаточностью тяжелой степени с целью лечения данных состояний Фраксипарин противопоказан.

In patients with mild or moderate renal failure, when using Fraxiparine for the purpose of preventing thromboembolism, the accumulation of nadroparine does not exceed that in patients with normal renal function taking Fraxiparine in therapeutic doses. When using Fraxiparine for the purpose of prevention, dose reduction in this category of patients is not required. In patients with severe renal failure receiving Fraxiparine in prophylactic doses, a dose reduction of 25% is necessary.

Low molecular weight heparin is injected into the arterial line of the dialysis loop in sufficiently high doses to prevent blood clotting in the dialysis loop. Pharmacokinetic parameters do not fundamentally change, except in the case of overdose, when the passage of the drug into the systemic circulation can lead to an increase in anti-Xa factor activity associated with the final phase of renal failure.

Indications

• prevention of thromboembolic complications (during surgical and orthopedic interventions; in patients with a high risk of thrombus formation in acute respiratory and/or heart failure in ICU settings);
• treatment of thromboembolism;
• prevention of blood clotting during hemodialysis;
• treatment of unstable angina and non-Q wave myocardial infarction.

Contraindications

• thrombocytopenia with a history of nadroparin use;
• signs of bleeding or increased risk of bleeding associated with impaired hemostasis (except for DIC not caused by heparin);
• organic lesions of organs with a tendency to bleeding (for example, acute gastric or duodenal ulcer);
• injuries or surgical interventions on the head and spinal cord or before our eyes;
• intracranial hemorrhage;
• acute septic endocarditis;
• severe renal failure (CK<30 мл/мин) у пациентов, получающих Фраксипарин для лечения тромбоэмболии, нестабильной стенокардии и инфаркта миокарда без зубца Q;
• childhood and adolescence (up to 18 years);
• hypersensitivity to nadroparin or any other components of the drug.

WITH caution Fraxiparine should be prescribed in situations associated with an increased risk of bleeding:

• with liver failure;
• with renal failure;
• for severe arterial hypertension;
• with a history of peptic ulcers or other diseases with an increased risk of bleeding;
• for circulatory disorders in choroid and the retina of the eye;
• in the postoperative period after operations on the brain, spinal cord or eyes;
• in patients weighing less than 40 kg;
• in case of treatment duration exceeding the recommended (10 days);
• in case of non-compliance with the recommended treatment conditions (especially the duration and dosage based on body weight for course use);
• when combined with drugs that increase the risk of bleeding.

Dosage

When administered subcutaneously, the drug is preferably administered with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.

To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, not at an angle, into the pinched fold of skin formed between the thumb and index finger. The fold should be maintained throughout the entire period of drug administration. Do not rub the injection site after injection.

For prevention of thromboembolism in general surgical practice The recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) s.c. The drug is administered 2-4 hours before surgery, then 1 time/day. Treatment is continued for at least 7 days or for the entire period of increased risk of thrombosis, until the patient is transferred to an outpatient regimen.

For prevention of thromboembolism during orthopedic operations Fraxiparine is administered subcutaneously at a dose determined depending on the patient’s body weight at the rate of 38 anti-Xa IU/kg, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine continues to be used 1 time/day throughout the entire period of increased risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

Patients at high risk of thrombosis (usually those in intensive care units (respiratory failure and/or respiratory tract infection and/or heart failure/) Fraxiparine is prescribed subcutaneously 1 time/day in a dose determined depending on the patient’s body weight. Fraxiparine is used throughout the entire period of risk of thrombosis.

At treatment of unstable angina and myocardial infarction without Q wave Fraxiparine is prescribed subcutaneously 2 times a day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies, patients with unstable angina/non-Q wave myocardial infarction were prescribed Fraxiparine in combination with at a dose of 325 mg/day.

The initial dose is administered as a single intravenous bolus injection, subsequent doses are administered subcutaneously. The dose is set depending on body weight at the rate of 86 anti-Xa IU/kg.

At treatment of thromboembolism oral anticoagulants (in the absence of contraindications) should be prescribed as early as possible. Fraxiparine therapy is not stopped until the target prothrombin time is achieved. The drug is prescribed subcutaneously 2 times a day (every 12 hours), the usual course duration is 10 days. The dose depends on the patient’s body weight at the rate of 86 anti-Xa IU/kg body weight.

Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis

The dose of Fraxiparine should be established for each patient individually, taking into account technical specifications dialysis.

Fraxiparine is administered once into the arterial line of the dialysis loop at the beginning of each session. For patients without an increased risk of bleeding, the recommended initial doses are set depending on body weight, but are sufficient for a 4-hour dialysis session.

In patients with an increased risk of bleeding, half the recommended dose of the drug can be used.

If the dialysis session lasts longer than 4 hours, additional small doses of Fraxiparine may be administered.

During subsequent dialysis sessions, the dose should be adjusted depending on the observed effects.

The patient should be monitored during the dialysis procedure for possible bleeding or signs of thrombus formation in the dialysis system.

U elderly patients

U patients with mild to moderate renal failure (CC ≥ 30 ml/min and< 60 мл/мин) For (QC< 30 мл/мин) the dose should be reduced by 25%.

U for thromboembolism treatment or for

Side effects

Adverse reactions are presented depending on the frequency of occurrence: very often (>1/10), often (>1/100,< 1/10), иногда (>1/1000, < 1/100), редко (>1/10 000, < 1/1000), очень редко (< 1/10 000).

From the blood coagulation system: very often - bleeding various localizations, more often in patients with other risk factors.

From the hematopoietic system: rarely - thrombocytopenia; very rarely - eosinophilia, reversible after discontinuation of the drug.

From the hepatobiliary system: often - increased activity of liver transaminases (usually transient).

From the outside immune system: very rarely - hypersensitivity reactions (Quincke's edema, skin reactions).

Local reactions: very often - the formation of a small subcutaneous hematoma at the injection site; in some cases, the appearance of dense nodules (not indicating heparin encapsulation) is observed, which disappear after a few days; very rarely - skin necrosis, usually at the injection site. The development of necrosis is usually preceded by purpura or an infiltrated or painful erythematous patch, which may or may not be accompanied by general symptoms (in such cases, treatment with Fraxiparine should be discontinued immediately).

Others: very rarely - priapism, reversible hyperkalemia (associated with the ability of heparins to suppress aldosterone secretion, especially in patients at risk).

Overdose

Symptoms: the main sign of overdose with subcutaneous and intravenous administration is bleeding; it is necessary to monitor the number of platelets and other parameters of the blood coagulation system.

Treatment: minor bleeding does not require special therapy (usually it is enough to reduce the dose or delay subsequent administration). has a pronounced neutralizing effect on the anticoagulant effects of heparin, however, in some cases, anti-Xa activity may be partially restored. The use of protamine sulfate is necessary only in severe cases. It should be taken into account that 0.6 ml of protamine sulfate neutralizes about 950 anti-Xa ME of nadroparin. The dose of protamine sulfate is calculated taking into account the time elapsed after heparin administration, with a possible reduction in the dose of the antidote.

Drug interactions

The development of hyperkalemia may depend on the simultaneous presence of several risk factors. Drugs that cause hyperkalemia: potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim. The risk of developing hyperkalemia increases when the above-mentioned drugs are combined with Fraxiparine.

The combined use of the drug Fraxiparine with drugs that affect hemostasis, such as acetylsalicylic acid, NSAIDs, indirect anticoagulants, fibrinolytics and dextran, leads to a mutual enhancement of the effect.

In addition, it should be taken into account that antiplatelet agents (except for acetylsalicylic acid as an analgesic and antipyretic drug, i.e. in a dose of over 500 mg): abciximab, acetylsalicylic acid in antiplatelet doses (50-300 mg) for cardiac and neurological indications , beraprost, clopidogrel, eptifibatide, iloprost, ticlopidine, tirofiban - increase the risk of bleeding.

The drug Fraxiparine should be prescribed with caution to patients receiving indirect anticoagulants, systemic corticosteroids and dextrans. Upon appointment indirect anticoagulants In patients receiving Fraxiparine, its use should be continued until the MHO level stabilizes to the required value.

special instructions

Particular attention should be paid to the specific instructions for use for each drug belonging to the LMWH class, because they may use different dosage units (IU or mg). Because of this, alternating Fraxiparine with other LMWHs during long-term treatment is unacceptable. It is also necessary to pay attention to which particular drug is used - Fraxiparine or, because this affects the dosage regimen.

Graduated syringes are designed to select the dose depending on the patient’s body weight.

Fraxiparine is not intended for intramuscular administration.

Heparin-induced thrombocytopenia

Since there is a possibility of developing thrombocytopenia (heparin-induced thrombocytopenia) when using heparins, the platelet count must be monitored during the entire course of treatment with Fraxiparine.

Rare cases of thrombocytopenia, sometimes severe, have been reported, which may be associated with arterial or venous thrombosis, which is important to consider in the following cases:

• with thrombocytopenia;
• with a significant decrease in platelet content (by 30-50% compared to the initial value);
• with negative dynamics of thrombosis for which the patient is receiving treatment;
• with thrombosis that developed during the use of the drug;
• with DIC syndrome.

In these cases, treatment with Fraxiparine should be discontinued.

These effects of an immunoallergic nature are usually observed between 5 and 21 days of treatment, but may occur earlier if the patient has a history of heparin-induced thrombocytopenia.

If there is a history of heparin-induced thrombocytopenia (due to unfractionated or low molecular weight heparins), treatment with Fraxiparine may be prescribed if necessary. However, strict clinical monitoring and, at a minimum, daily platelet count measurement are indicated in this situation. If thrombocytopenia occurs, use of Fraxiparine should be stopped immediately.

If thrombocytopenia occurs against the background of heparins (unfractionated or low molecular weight), then the possibility of prescribing anticoagulants of other groups should be considered. If other drugs are not available, then another LMWH may be used. In this case, the number of platelets in the blood should be monitored daily. If signs of incipient thrombocytopenia continue to be observed after changing the drug, then treatment should be stopped as soon as possible. It must be remembered that monitoring of platelet aggregation based on in vitro tests is of limited value in the diagnosis of heparin-induced thrombocytopenia.

Elderly patients

Before starting treatment with Fraxiparine, renal function should be assessed.

Hyperkalemia

Heparins may suppress aldosterone secretion, which may lead to hyperkalemia, especially in patients with elevated blood potassium concentrations or in patients at risk for elevated blood potassium levels (eg, patients with diabetes mellitus, chronic renal failure, metabolic acidosis or patients taking drugs that can cause hyperkalemia (including ACE inhibitors, NSAIDs)). The risk of hyperkalemia increases with long-term therapy but is usually reversible with discontinuation. In patients at risk, the concentration of potassium in the blood should be monitored.

Spinal/epidural anesthesia/lumbar puncture and related medications

The risk of spinal/epidural hematomas increases in persons with installed epidural catheters or concomitant use of other medicines that may affect hemostasis, such as NSAIDs, antiplatelet agents or other anticoagulants. The risk also appears to increase with traumatic or repeated epidural or spinal taps. Thus, the issue of the combined use of neuraxial blockade and anticoagulants should be decided individually after assessing the benefit/risk ratio in the following situations:

• in patients already receiving anticoagulants, the need for spinal or epidural anesthesia must be justified;
• in patients planning elective surgery using spinal or epidural anesthesia, the need for anticoagulants should be justified.

When performing a lumbar puncture or spinal/epidural anesthesia, a minimum of 12 hours must elapse between the administration of Fraxiparine for prophylaxis or 24 hours for treatment and the insertion or removal of a spinal/epidural catheter or needle. In patients with renal impairment, increasing these intervals may be considered. Careful monitoring of the patient is necessary to identify signs and symptoms of neurological disorders. If disturbances are detected in the patient’s neurological status, urgent appropriate therapy is required.

Salicylates, NSAIDs and antiplatelet agents

For prevention or treatment venous thromboembolism, as well as for the prevention of blood clotting in the extracorporeal circulatory system during hemodialysis, the simultaneous use of the drug Fraxiparine with drugs such as NSAIDs (including acetylsalicylic acid and other salicylates) and antiplatelet agents is not recommended, because this may increase the risk of bleeding.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of Fraxiparine on the ability to drive vehicles, mechanisms.

Pregnancy and lactation

Animal studies have not shown teratogenic or fetotoxic effects of nadroparin calcium, however, there are currently only limited data regarding the penetration of nadroparin calcium across the placenta in humans. Therefore, the use of Fraxiparine during pregnancy is not recommended, unless the potential benefit to the mother outweighs the risk to the fetus.

Currently, there are only limited data regarding the excretion of nadroparin calcium into breast milk. In this regard, the use of nadroparin calcium during the period breastfeeding Not recommended.

Use in childhood

Contraindication: childhood and adolescence (up to 18 years).

For impaired renal function

In patients with mild to moderate renal failure(CC ≥ 30 ml/min and< 60 мл/мин) для prevention of thrombosis no dose reduction required patients with severe renal failure(QC< 30 мл/мин) дозу следует снизить на 25%.

U patients with mild to moderate renal failure for l Treatments for thromboembolism or for prevention of thromboembolism in patients with a high risk of thrombus formation (with unstable angina and myocardial infarction without a Q wave) the dose should be reduced by 25%; the drug is contraindicated in patients with severe renal failure.

For liver dysfunction

U patients with liver dysfunction Special studies on the use of the drug have not been conducted.

Use in old age

U elderly patients no dose adjustment is required (except for patients with impaired renal function). Before starting treatment with Fraxiparine, it is recommended to monitor renal function indicators.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored out of the reach of children, at a temperature not exceeding 30°C; do not freeze. Shelf life - 3 years.

Seprotin, Sinkumar, Trombless, Thrombophobe, Troparin, Phenilin, Fragmin, Tsibor 2500, Tsibor 3500, Exanta SK, Eliquis, Emeran, Enoxaparin sodium

Recipe (international)

Rp: Fraxiparini 2850 ME - 0.3 ml
D.t.d: No.10 in amp.
S: Into the subcutaneous fat.

pharmachologic effect

Nadroparin calcium is a low molecular weight heparin (LMWH), obtained by depolymerization from standard heparin, is a glycosaminoglycan with an average molecular weight of 4300 daltons.
Shows a high ability to bind to the blood plasma protein antithrombin III (AT III). This binding leads to accelerated inhibition of factor Xa, which accounts for the high antithrombotic potential of nadroparin.
Other mechanisms mediating the antithrombotic effect of nadroparin include activation of tissue factor converting inhibitor (TFPI), activation of fibrinolysis through direct release of tissue plasminogen activator from endothelial cells, and modification of blood rheological properties (decreasing blood viscosity and increasing platelet and granulocyte membrane permeability).
Nadroparin calcium is characterized by higher anti-Xa factor activity compared to anti-IIa factor or antithrombotic activity and has both immediate and prolonged antithrombotic activity.

Compared with unfractionated heparin, nadroparin has a lesser effect on platelet function and aggregation and a less pronounced effect on primary hemostasis.
In prophylactic doses, nadroparin does not cause a significant decrease in aPTT.

During a course of treatment during the period of maximum activity, it is possible to increase the aPTT to a value 1.4 times higher than the standard one. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.

Mode of application

For adults: When administered subcutaneously, the drug is preferably administered with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.
To avoid loss of the drug when using syringes, do not remove air bubbles before injection.
In patients with an increased risk of bleeding, half the recommended dose of the drug can be used.

If the dialysis session lasts longer than 4 hours, additional small doses of Fraxiparine may be administered.

During subsequent dialysis sessions, the dose should be adjusted depending on the observed effects.

The patient should be monitored during the dialysis procedure for possible bleeding or signs of thrombus formation in the dialysis system.

In elderly patients, no dose adjustment is required (except for patients with impaired renal function). Before starting treatment with Fraxiparine, it is recommended to monitor renal function indicators.

In patients with mild to moderate renal insufficiency (creatinine clearance ≥ 30 ml/min and in patients with mild to moderate renal insufficiency for the treatment of thromboembolism or for the prevention of thromboembolism in patients at high risk of thrombus formation (with unstable angina and non-Q wave myocardial infarction) the dose should be reduced by 25%; the drug is contraindicated in patients with severe renal failure.

In patients with impaired liver function, special studies on the use of the drug have not been conducted.
The needle should be inserted perpendicularly, not at an angle, into the pinched fold of skin formed between the thumb and index finger. The fold should be maintained throughout the entire period of drug administration. Do not rub the injection site after injection.

For the prevention of thromboembolism in general surgical practice, the recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) subcutaneously. The drug is administered 2-4 hours before surgery, then 1 time/day. Treatment is continued for at least 7 days or for the entire period of increased risk of thrombosis, until the patient is transferred to an outpatient regimen.

To prevent thromboembolism during orthopedic operations, Fraxiparine is administered subcutaneously at a dose determined depending on the patient’s body weight at the rate of 38 anti-Xa IU/kg, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine continues to be used 1 time/day throughout the entire period of increased risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

Indications

Prevention of thromboembolic complications (during surgical and orthopedic interventions; in patients with a high risk of thrombus formation in acute respiratory and/or heart failure in ICU settings);
- treatment of thromboembolism;
- prevention of blood clotting during hemodialysis;
- treatment of unstable angina and myocardial infarction without Q wave.

Contraindications

A history of thrombocytopenia with the use of nadroparin;
- signs of bleeding or increased risk of bleeding associated with impaired hemostasis (with the exception of disseminated intravascular coagulation syndrome not caused by heparin);
- organic lesions of organs with a tendency to bleeding (for example, acute gastric or duodenal ulcer);
- injuries or surgical interventions on the brain, spinal cord or eyes;
- intracranial hemorrhage;
- acute septic endocarditis;
- severe renal failure (KK - childhood and adolescence (up to 18 years);
- hypersensitivity to nadroparin or any other components of the drug.
Fraxiparine should be prescribed with caution in situations associated with an increased risk of bleeding:
- with liver failure;
- in case of renal failure;
- with severe arterial hypertension;
- with a history of peptic ulcers or other diseases with an increased risk of bleeding;
- for circulatory disorders in the choroid and retina of the eye;
- in the postoperative period after operations on the brain, spinal cord or eyes;
- in patients weighing less than 40 kg;
- in case of treatment duration exceeding the recommended (10 days);
- in case of non-compliance with the recommended treatment conditions (especially the duration and dosage based on body weight for course use);
- when combined with drugs that increase the risk of bleeding.

Side effects

From the blood coagulation system: very often - bleeding of various locations, more often in patients with other risk factors.

From the hematopoietic system: rarely - thrombocytopenia; very rarely - eosinophilia, reversible after discontinuation of the drug.

From the hepatobiliary system: often - increased activity of liver transaminases (usually transient).

From the immune system: very rarely - hypersensitivity reactions (Quincke's edema, skin reactions).

Local reactions: very often - the formation of a small subcutaneous hematoma at the injection site; in some cases, the appearance of dense nodules (not indicating heparin encapsulation) is observed, which disappear after a few days; very rarely - skin necrosis, usually at the injection site.
The development of necrosis is usually preceded by purpura or an infiltrated or painful erythematous patch, which may or may not be accompanied by general symptoms (in such cases, treatment with Fraxiparine should be discontinued immediately).

Others: very rarely - priapism, reversible hyperkalemia (associated with the ability of heparins to suppress aldosterone secretion, especially in patients at risk).

Release form

1 syringe
nadroparin calcium 2850 IU anti-Xa
Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.3 ml).

0.3 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.3 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow.

1 syringe
nadroparin calcium 3800 IU anti-Xa
Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.4 ml).

0.4 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.4 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow.

1 syringe
nadroparin calcium 5700 IU anti-Xa
Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.6 ml).

0.6 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.6 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow.

1 syringe
nadroparin calcium 7600 IU anti-Xa
Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 0.8 ml).

0.8 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
0.8 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

The solution for subcutaneous administration is clear, slightly opalescent, colorless or light yellow.

1 syringe
nadroparin calcium 9500 IU anti-Xa
Excipients: calcium hydroxide solution or diluted hydrochloric acid (up to pH 5.0-7.5), water for injection (up to 1 ml).

1 ml - single-dose syringes (2) - blisters (1) - cardboard packs.
1 ml - single-dose syringes (2) - blisters (5) - cardboard packs.

ATTENTION!

The information on the page you are viewing is created for informational purposes only and does not in any way promote self-medication. The resource is intended to provide healthcare workers with additional information about certain medications, thereby increasing their level of professionalism. The use of the drug "" necessarily requires consultation with a specialist, as well as his recommendations on the method of use and dosage of the medicine you have chosen.

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medside.ru

Fraxiparine:: Instructions:: Price:: Description of the drug

In stock UAH.

Release forms:

Buy These products are located on the website of the pharmacy chain "Thetida" Active ingredient: nadroparin calcium; 1 ml of injection solution contains 9500 IU of anti-Xa nadroparin calcium; excipients: calcium hydroxide or hydrochloric acid, water for injection. Nadroparin calcium ( active substance Fraxiparina) is a low molecular weight heparin obtained from standard heparin by depolymerization under special conditions. The drug is characterized by pronounced activity against blood clotting factor Xa and weak activity against factor Pa. The Angi-Ha activity (i.e., antiplatelet/anti-platelet adhesion activity) of the drug is more pronounced than its effect on activated partial thromboplastin time (an indicator of blood clotting rate), which distinguishes nadroparin calcium from unfractionated standard heparin. Thus, the drug has antithrombotic activity (preventing the formation of a blood clot), has a quick and long-lasting effect. The use of Fraxiparine is recommended for: prevention of thromboembolic complications (formation of blood clots in the veins) after surgical interventions, both in general and orthopedic surgery; in non-surgical patients with a high risk of developing thromboembolic complications (acute respiratory failure and/or respiratory infection, acute heart failure), in patients undergoing treatment in intensive care units; prevention of blood clotting during hemodialysis; treatment of thromboembolic complications; on ECG. Fraxiparin is intended for subcutaneous and intravenous administration. Do not use Fraxiparine intramuscularly. When Fraxiparine is administered, it should not be mixed with other drugs.

Prevention of thromboembolic complicationsGeneral surgery. The usual recommended dose is 0.3 ml of Fraxiparine once a day subcutaneously for at least 7 days. In any case, prophylaxis should be carried out during the period of risk. The first dose is administered 2 to 4 hours before surgery. Orthopedic surgery. The initial dose of Fraxiparine is administered 12 hours before surgery and 12 hours after it. The use of the drug is continued for at least 10 days. In any case, prophylaxis should be carried out during the period of risk. The dose depends on the patient’s body weight and is determined according to the table below:

Treatment of thromboembolic complications Fraxiparin is administered subcutaneously twice a day (every 12 hours), usually for 10 days. The dose depends on the patient’s body weight and is determined according to the table below:

Prevention of blood clotting during hemodialysis Doses of the drug are selected individually, taking into account the technical conditions of dialysis. Fraxiparine is usually administered as a single injection into the arterial circuit at the beginning of each procedure. Recommended starting doses for patients without an increased risk of bleeding are shown in the table below:

Treatment of unstable angina and myocardial infarction without a Q wave on the ECG. It is recommended to use Fraxiparine in combination with aspirin (up to 325 mg per day). The usual duration of treatment is 6 days. The initial dose of Fraxiparine is administered intravenously at a previously established venous catheter at a dose of 86 IU anti-Xa/kg, and then the same dose subcutaneously every 12 hours. The recommended doses of Fraxiparine are shown in the table below:

The description of the drug "Fraxiparin" on this page is a simplified and expanded version official instructions by application. Before purchasing or using the drug, you should consult your doctor and read the instructions approved by the manufacturer. Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

www.piluli.kharkov.ua

instructions for use, analogues, composition, indications

Compound

pharmachologic effect

Pharmacokinetics

Indications for use

Contraindications

Directions for use and doses

The injection is carried out in subcutaneous tissue belly. The needle is inserted perpendicularly into the thickness of the skin fold formed between the thumb and index finger. The fold should be maintained throughout the entire insertion period. 1 unit (V) of antiXa fraxiparine corresponds to 0.41 international unit (VI) of antiXa;

Preventive treatment of thromboembolic disease. General surgery: prevention is based on a single daily dose of Fraxiparine 0.3 ml. A dose of 0.3 ml is administered 2-4 hours before surgery. The total duration of treatment is at least 7 days. It is recommended to carry out prophylaxis during the entire period of risk, until the patient’s motor activity is completely restored. Orthopedic surgery: the dose of the drug is selected depending on the patient’s body weight. The drug is administered once a day daily in the following doses: For patients weighing less than 50 kg: in the preoperative period and for 3 days after surgery - 0.2 ml; in the postoperative period (starting from the 4th day) - 0.3 ml. For patients weighing from 51 to 70 kg: in the preoperative period and within 3 days after surgery - 0.3 ml; in the postoperative period (starting from the 4th day) - 0.4 ml. For patients weighing from 71 to 95 kg: in the preoperative period and within 3 days after surgery - 0.4 ml; in the postoperative period (starting from the 4th day) - 0.6 ml. The course is at least 10 days.

Medicinal use: Prevention of coagulation during hemodialysis: in patients without the risk of bleeding and for a session not exceeding 4 hours, at the beginning of the session, inject a single dose into the arterial line: - Patients weighing less than 50 kg: 0.3 ml - Patients weighing from 51 to 70 kg: 0.4 ml - Patients with body weight above 71 kg: 0.6 ml If necessary, the dose will be more accurately selected depending on each individual case and the technical conditions of dialysis. In patients with hemorrhagic risk, it will be possible to conduct a dialysis session using doses reduced by half. Fraxiparine replaces traditional heparin therapy, carried out while awaiting the results of venography. Fraxiparine is administered every 12 hours for 10 days. The dose of the drug depends on the patient’s body weight: with a body weight of 45 kg - 0.4 ml; 55 kg-0.5 ml; 70 kg-0.6 ml; 80 kg-0.7 ml; 90 kg-0.8 ml; 100 kg or more - 0.9 ml.

Side effect

Overdose

Interaction with other drugs

Features of application

Release form

Solution for subcutaneous administration of 9500 IU anti-Xa/ml in multi-dose vials.

5 ml or 15 ml of solution in a type I flint glass bottle, sealed with a chlorobutyl rubber stopper, crimped with a tear-off aluminum cap with a protective plastic cap.

10 bottles each along with instructions for medical use placed in a cardboard box.

Storage conditions

At temperatures below 30 °C. Do not freeze.

The opened bottle should be stored at a temperature below Keep out of the reach of children.

Best before date

The shelf life of the drug after opening the bottle is 28 days.

Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

Fraxiparine analogues, synonyms and group drugs

Self-medication may be harmful to your health. You should consult your doctor and also read the instructions before use.

apteka.103.by

Name: Fraxiparine

Indications for use: The use of Fraxiparine is recommended for: prevention of thromboembolic complications (formation of blood clots in the veins) after surgical interventions, both in general and orthopedic surgery; in non-surgical patients with an increased risk of developing thromboembolic complications (acute respiratory failure and/or respiratory infection, acute heart failure), in patients undergoing treatment in intensive care units; prevention of blood clotting during hemodialysis; treatment of thromboembolic complications; treatment of unstable angina and myocardial infarction without a Q wave on the ECG.

Pharmacological action: Nadroparin calcium (the active ingredient of Fraxiparin) is a low-molecular-weight heparin obtained from standard heparin by depolymerization under special conditions. The drug is characterized by pronounced activity against blood clotting factor Xa and weak activity against factor Pa. The Angi-Ha activity (i.e., antiplatelet/anti-platelet adhesion activity) of the product is more pronounced than its effect on activated partial thromboplastin time (an indicator of blood clotting rate), which distinguishes nadroparin calcium from unfractionated standard heparin. Thus, the product has antithrombotic activity (preventing the formation of a blood clot) and has a quick and long-lasting effect.

Fraxiparine method of administration and dosage: Fraxiparine is intended for subcutaneous and intravenous administration. Do not use Fraxiparine intramuscularly. When Fraxiparine is administered, it should not be mixed with other products.

Prevention of thromboembolic complicationsGeneral surgery. The usual recommended dose is 0.3 ml of Fraxiparine once a day subcutaneously for at least 7 days. In any case, prevention must be carried out throughout the period of risk. The first dose is administered 2 to 4 hours before surgery. Orthopedic surgery. The initial dose of Fraxiparine is administered 12 hours before surgery and 12 hours afterwards. Use of the product is continued for at least 10 days. In any case, prevention must be carried out throughout the period of risk. The dose depends on the body weight of the patient and is determined according to the table below:

Non-surgical intensive care unit patients

Treatment of thromboembolic complications Fraxiparin is administered subcutaneously twice a day (every 12 hours), usually for 10 days. The dose depends on the body weight of the patient and is determined according to the table below:

Prevention of blood clotting during hemodialysis Doses of the product are selected individually, taking into account the technical conditions of dialysis. Fraxiparine is usually administered as a single injection into the arterial circuit at the beginning of each procedure. Recommended starting doses for patients without an increased risk of bleeding are shown in the table below:

Treatment of unstable angina and myocardial infarction without a Q wave on the ECG. It is recommended to use Fraxiparine in combination with aspirin (up to 325 mg per day). The usual duration of treatment is 6 days. The initial dose of Fraxiparine is administered intravenously into a pre-installed venous catheter at a dose of 86 IU anti-Xa/kg, and then the same dose subcutaneously 12 hours later. Recommended doses of Fraxiparine are indicated in the table below:

Fraxiparine contraindications: Fraxiparine is not recommended for use in the following cases: if you are allergic to nadroparin calcium; if thrombocytopenia has developed in the past when using nadroparin calcium; with bleeding or increased risk of bleeding; with peptic ulcer of the stomach or duodenum in the acute stage; with hemorrhagic cerebrovascular injury; in acute infective endocarditis.

Fraxiparine side effects: When using Fraxiparine, allergic reactions, bleeding in different places, a reversible increase in the level of liver enzymes, small hematomas or dense painful nodules at the injection sites may be observed, which usually disappear after a few days. If the skin becomes red and a painful lump forms at the site of injection of the product, use Fraxiparine you should stop immediately and consult a doctor. In some cases, thrombocytopenia, eosinophilia and hyperkalemia (reversible after stopping treatment) may occur. If any unusual reactions occur, be sure to consult your doctor about the possibility of further use of the product.

Pregnancy: The use of Fraxiparine during pregnancy, except in cases where the therapeutic benefit outweighs the possible risk. The use of Fraxiparine during breastfeeding is not recommended.

Overdose: In case of an overdose of the product, bleeding of varying severity appears. Minor bleeding requires reducing doses or increasing the interval between administration of the product. For significant bleeding, the use of protamine sulfate is recommended. 0.6 ml of protamine sulfate neutralizes within 0.1 ml of Fraxiparine.

Use with other medicinal products: During treatment with Fraxiparin, you should not take any other medications (including those sold without a prescription) without first consulting your doctor. The simultaneous use of Fraxiparin with aspirin is not recommended (except for the treatment of unstable angina and non-Q wave myocardial infarction) and other salicylates, non-steroidal anti-inflammatory products without prior consultation with your doctor. You should inform your doctor if you are taking oral anticoagulants, glucocorticosteroids or dextrans.

Release form: 1 pre-filled syringe in a blister, 2 or 10 blisters in a cardboard box. Injection solutions in pre-filled syringes contain:

Storage conditions: Store out of the reach of children, at room temperature (up to 30°C), away from heating devices. Dispensing conditions from pharmacies - by prescription.

Synonyms: Nadroparin calcium (Nadropariri calcium)

Fraxiparine composition: Active ingredient: nadroparin calcium; 1 ml of solution for injection contains 9500 IU of anti-Xa nadroparin calcium; excipients: calcium hydroxide or hydrochloric acid, water for injection.

Additionally: Fraxiparin should not be used intramuscularly. Treatment with Fraxiparine should be carried out under the supervision of a physician. The use of Fraxiparine can lead to hyperkalemia, which is usually reversible, especially in patients with elevated plasma potassium levels and in patients at risk of increased plasma potassium levels.

Attention! Before using the drug "Fraxiparin", you must consult a doctor. The instructions are provided solely for information about "Fraxiparin".

Group affiliation:

medprep.info

Fraxiparine Solution for injection (syringes): instructions, description PharmPrice

Instructions for medical use

medicine

Tradename

International generic name

Nadroparin calcium

Dosage form

Solution for injection, 3800 IU anti-Xa/0.4 ml No. 10

1 syringe contains

active substance – nadroparin calcium 3800 IU anti-Xa,

excipients: calcium hydroxide solution or hydrochloric acid diluted to pH 5-7.5, water for injection up to 0.4 ml

Description

Transparent or slightly opalescent, colorless or light yellow solution

Pharmacotherapeutic group

Anticoagulants. Direct anticoagulants (heparin and its derivatives). Nadroparin.

ATX code B01AB06

Pharmacological properties

Pharmacokinetics

The pharmacokinetic properties of nadroparin are based on biological activity, that is, on changes in anti-Xa factor activity.

The maximum level of anti-Xa activity (Cmax) is achieved 3-4 hours after subcutaneous administration 2 times a day, when using Fraxiparine 1 time a day - after 4-6 hours. Bioavailability is almost complete (about 88%).

After intravenous administration, the maximum level of anti-Xa activity in plasma is achieved within 10 minutes, and the half-life is about 2 hours. Metabolism occurs mainly in the liver (desulfation, depolymerization). It is excreted primarily by the kidneys.

Anti-Xa activity persists for 18 hours after administration of the drug.

Special patient groups

Due to a possible decrease in renal function, the elimination of nadroparin is slowed down in elderly patients. Before prescribing the drug, it is necessary to assess renal function and adjust the prescribed dose accordingly.

Patients with impaired renal function

In clinical studies of the pharmacokinetics of nadroparin in patients with varying degrees of renal failure, a correlation was found between the clearance of nadroparin and creatinine clearance. In patients with moderate renal failure (creatinine clearance 36-43 ml/min), AUC and T1\2 increased by 52 and 39%, respectively, with a decrease in plasma clearance of nadroparin by 63%. In patients with severe renal failure (creatinine clearance 10-20 ml/min), AUC and T1/2 increased by 95 and 112%, respectively, with a decrease in plasma clearance of nadroparin by 50%. In patients with a creatinine clearance of 3-6 ml/min or on hemodialysis, AUC and T1/2 increased by 62 and 65%, respectively, with a decrease in plasma clearance of nadroparin by 67%.

Pharmacodynamics

The active substance of the drug is nadroparin calcium - low molecular weight heparin, obtained by depolymerization of standard heparin under special conditions. It is a glycosaminoglycan with an average molecular weight of approximately 4300 daltons. Fraxiparine exhibits high similarity to plasma protein antithrombin. This leads to accelerated suppression of factor Xa, which stimulates the high antithrombic potential of Fraxiparine.

Other mechanisms for enhancing antithrombotic activity include stimulation of tissue factor inhibitor, activation of fibrinolysis by direct release of tissue plasmogenic activator from endothelial cells and modification of hemorheological parameters (decreasing blood viscosity and increasing platelet count, granulocyte membrane variability).

The drug is characterized by more pronounced anti-Xa factor activity compared to anti-IIa factor activity. The ratios between the two activities for Fraxiparine are in the range of 2.5-4. It has both immediate and prolonged antithrombic effects.

Compared with unfractionated heparins, Fraxiparine has less effect on platelet function and aggregation and a negligible effect on overall hemostasis.

Indications for use

prevention of thromboembolic complications (associated with general or orthopedic surgery, in non-surgical patients - with acute respiratory failure, respiratory infection and/or acute heart failure in an intensive care unit)

prevention of blood clotting during hemodialysis

treatment of thromboembolism

treatment of unstable angina and myocardial infarction without Q wave

Directions for use and doses

Instructions for administering the drug

For subcutaneous administration. Do not use intramuscularly.

1. Wash your hands with soap and dry them with a towel.

Sit or lie down in a comfortable position. Fraxiparine is injected subcutaneously into the abdominal area 1.5-2 cm below the navel. Select the left or right area as shown in the picture. Alternatively, the drug may be injected into the thigh.

2. Clean the intended injection site with an alcohol swab.

3.Remove the protective cap from the needle. If the amount of solution in the syringe exceeds the dose recommended by your doctor, remove the excess amount. Gently press the plunger of the syringe to bring the amount of solution to the level recommended by your doctor. Avoid contact of the needle with other surfaces until insertion. A small amount of bubbles in the solution is normal and there is no need to remove them.

4.Gently grab the skin in the fold between your thumb and forefinger.

5. The needle should be inserted perpendicularly, not at an angle, into the pinched fold of skin, which should be held between the thumb and forefinger during the entire insertion period.

6. Inject the entire amount of solution that is in the syringe.

Remove the needle from the injection site. The injection site should not be rubbed.

7.For safety reasons, put the protective cap on the needle after the injection. Dispose of the used syringe as directed by your doctor.

Fraxiparine should not be used interchangeably with other low molecular weight heparins during the course of therapy.

Platelet counts should be monitored throughout treatment.

Prevention of thromboembolic disorders

general surgery

In general surgery, a dose of Fraxiparine 0.3 ml (2850 IU anti-Xa) is administered subcutaneously 2-4 hours before surgery, and then, in the following days, 1 time per day. The total duration of treatment is at least 7 days. It is recommended to carry out prevention during the entire period of risk.

Orthopedics

In orthopedic practice, the dose is selected depending on the patient’s body weight and is administered subcutaneously in accordance with Table 1. The first dose is administered 12 hours before surgery, the second – 12 hours after surgery. The drug is administered once a day, the minimum duration of treatment is 10 days.

Table 1

For patients with a high thromboembolic risk in the intensive care unit (acute respiratory failure, respiratory infection, acute heart failure), treatment is continued throughout the entire period of risk of thromboembolism. The dose is selected depending on the patient’s body weight, according to Table 2.

table 2

Treatment of thromboembolic disorders

When treating thromboembolic complications, therapy with oral anticoagulants, in the absence of contraindications, should be started as soon as possible.

Fraxiparine is administered subcutaneously every 12 hours.

The dose is selected depending on the patient’s body weight, according to Table 3.

Table 3

Prevention of blood clotting during hemodialysis Fraxiparine is usually used as a single dose in the intra-arterial infusion system at the beginning of each procedure.

For patients without an increased risk of bleeding, initial doses are determined based on the patient's body weight, according to Table 4.

Table 4

Patients with an increased risk of bleeding should be given half the dose. An additional, smaller dose may be administered during dialysis lasting more than 4 hours. The dosage for sequential dialysis should be adjusted according to the observed effect. Patients should be closely monitored during each dialysis procedure for signs of bleeding or clotting.

Treatment of unstable angina and non-Q wave myocardial infarction

Fraxiparine is administered subcutaneously 2 times a day (every 12 hours) in combination with acetylsalicylic acid (up to 325 mg per day). The duration of treatment is 6 days. The initial dose is determined at 86 IU anti-Xa/kg and should be administered as an intravenous bolus. Then the same dose is administered subcutaneously. Doses are determined depending on body weight in accordance with Table 5.

Table 5

In elderly patients, the dose is adjusted if necessary, except in cases of renal impairment.

Kidney failure

There is no need to adjust the dose if creatinine clearance is greater than or equal to 50 ml/min. In moderate to severe renal failure, increased exposure to nadroparin may occur, leading to an increased risk of thromboembolism and hemorrhage. In such patients (creatinine clearance less than 30 ml/min or 30 ml/min - 50 ml/min), the dose of Fraxiparine should be reduced by 25-33%.

Liver failure

No studies have been conducted.

Use in pediatrics

Side effects

Increased bleeding, mild thrombocytopenia (including heparin-induced thrombocytopenia), thrombocytosis, reversible eosinophilia

Allergic reactions, urticaria, rash, erythema, including angioedema, skin necrosis (at the injection site), anaphylactic reactions

Reversible hyperkalemia

Temporary increase in liver enzyme levels

Small hematomas, hard nodules or calcinosis at the injection site that disappear after a few days

Priapism

Hypersensitivity to the latex contained in the needle guard

Contraindications

Hypersensitivity to nadroparin or excipients

Severe thrombocytopenia associated with the use of heparin or nadroparin

Intraocular hemorrhage and other bleeding or increased risk of bleeding associated with impaired hemostasis, excluding disseminated intravascular coagulation (DIC) not caused by heparin

Organic diseases with the potential for bleeding (eg, gastric or duodenal ulcer, cerebral bleeding, cerebral aneurysm)

Hemorrhagic cerebrovascular injury

Acute infective endocarditis

Severe uncontrolled hypertension

Severe renal failure (creatinine clearance less than 30 ml/min) except time on hemodialysis

Injuries and surgeries to the central nervous system, eye or ear

Retinopathy, hemorrhages in vitreous eyes

Threatened abortion

Children and teenagers up to 18 years of age

Drug interactions

The drug Fraxiparine is prescribed with caution when used simultaneously with oral anticoagulants, systemic glucocorticosteroids and dextrans. When prescribing oral anticoagulants to patients already receiving Fraxiparine, Fraxiparine is used until the INR normalizes.

With simultaneous use of Fraxiparine with potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II inhibitors, non-steroidal anti-inflammatory drugs, heparins, cyclosporine, the development of hyperkalemia is observed.

Fraxiparine can enhance the anticoagulant effect of the following drugs: non-steroidal anti-inflammatory drugs, acetylsalicylic acid and preparations containing it, platelet antiplatelet agents, glucocorticosteroids, and therefore their combined use with Fraxiparine is not recommended. In cases where the use of these combinations cannot be avoided, caution should be exercised in the ongoing assessment of the blood coagulation system and general clinical condition.

special instructions

Heparin-induced thrombocytopenia

Due to the possibility of heparin-induced thrombocytopenia, the platelet count should be monitored throughout the course of treatment with Fraxiparine.

Rare cases of thrombocytopenia, some severe, that have been associated with arterial or venous thrombosis have been identified. The diagnosis of heparin-induced thrombocytopenia should be considered in the following conditions:

Thrombocytopenia

Any significant decrease in platelet count (30-50% from baseline)

Vascular thrombosis or worsening of existing thrombosis during ongoing therapy

DIC syndrome

If any of the above conditions develop, treatment with nadroparin should be discontinued.

These symptoms may be of an immuno-allergic nature and, during the first use of the drug, their occurrence is described between 5 and 21 days, but may appear earlier in the case of thrombocytopenia that occurs during the use of heparin.

If there are known cases of heparin-induced thrombocytopenia (when using standard or low molecular weight heparins), the use of nadroparin should be considered by the attending physician. If positive, the platelet count and assessment should be monitored daily throughout the course of treatment with nadroparin. If heparin-induced thrombocytopenia develops, treatment with nadroparin should be discontinued immediately and replaced with another class of antithrombotic drugs. If this is not possible, another low molecular weight heparin can be used, but platelet counts and assessments should be monitored at least daily and the drug should be discontinued as soon as possible, as thrombocytopenia has been reported with other classes of antithrombotic drugs.

In vitro platelet aggregation tests are of limited value in the diagnosis of heparin-induced thrombocytopenia.

Nadroparin should be used with caution in the following situations, which may be associated with an increased risk of bleeding:

Liver failure

Severe arterial hypertension

History of peptic ulcer and other diseases with an increased risk of bleeding

Circulatory disorders in the choroid and retina of the eye

Postoperative period after surgical interventions on the brain, spinal cord, eyes

Hyperkalemia

Heparin may suppress adrenal secretion of aldosterone leading to hyperkalemia, especially in patients at risk of elevated plasma potassium levels, in patients with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, or when taking drugs that cause hyperkalemia (eg, ACE inhibitors, nonsteroidal anti-inflammatory drugs). facilities).

The risk of developing hyperkalemia increases with increasing duration of therapy, but is usually reversible.

In patients at risk of hyperkalemia, plasma potassium levels should be monitored.

Spinal and epidural anesthesia/lumbar puncture and combined use with other drugs

If spinal or epidural anesthesia is necessary while using the drug Fraxiparine, rare cases of intraspinal hematoma, even the development of long-term paralysis, have been observed. The risk of developing intraspinal hematoma increases with the use of an epidural catheter or with the concomitant use of other drugs that can cause hemostasis, such as nonsteroidal anti-inflammatory drugs, platelet inhibitors or other anticoagulants, as well as with traumatic, repeated epidural or spinal puncture.

Therefore, a careful benefit-risk assessment must be made joint application nerve blockade and anticoagulants in the following cases:

In patients already on anticoagulant treatment, the benefits of nerve blockade should be assessed against the possible risks.

In patients planning surgery using nerve blockade, it is necessary to evaluate the benefits of anticoagulants in relation to the possible risks.

If it is necessary to combine such anesthesia and the prescription of nadroparin, it should be taken into account that in the case of spinal/epidural anesthesia or lumbar puncture, an interval of at least 12 hours must be maintained between the injection of Fraxiparin and the insertion/removal of a needle or catheter in the case of its prophylactic administration, or 24 hours in the case of its prescribed in therapeutic doses. For patients with renal impairment, lengthening the suggested interval should be considered.

Patients require careful neurological monitoring in case of signs and symptoms of neurological disorders and, if necessary, emergency treatment measures.

Salicylates, non-steroidal anti-inflammatory drugs and platelet inhibitors

For prophylactic or therapeutic purposes to eliminate thromboembolic disorders and prevent blood clotting during hemodialysis, the concomitant use of aspirin, NSAIDs or platelet inhibitors is not recommended, as this may increase the risk of bleeding. When this combination cannot be avoided, monitoring of the patient's clinical and biological parameters is necessary.

In clinical studies in the treatment of unstable angina and non-Q wave myocardial infarction, Fraxiparine was prescribed in combination with acetylsalicylic acid (up to 325 mg per day).

Kidney failure

Nadroparin is excreted primarily by the kidneys, therefore, if renal function is impaired, the exposure of nadroparin may increase, and therefore the risk of bleeding increases in such patients, and the drug should be used with caution.

With a creatinine clearance of 30-50 mg/ml, the attending physician should consider reducing the dose of Fraxiparine based on an assessment of the risk between possible bleeding and the development of thromboembolism.

Before prescribing the drug, it is necessary to monitor renal function.

Skin necrosis

In very rare cases, cases of necrosis have been identified skin, the prerequisites of which were purpura, infiltration, or painful erythematous plaques, with or without associated general symptoms. If these symptoms develop, treatment with Fraxiparine should be stopped immediately.

The needle sheath may contain latex, which can lead to the development of allergic reactions in patients with latex allergies.

Fertility

Clinical studies on the effect of nadroparin on fertility have not been conducted.

Pregnancy and lactation

Data on the use of nadroparin during pregnancy and lactation are limited.

The use of the drug during pregnancy is not recommended, unless the therapeutic benefit does not outweigh the possible risk.

There is no information on the penetration of nadroparin into breast milk; however, the use of Fraxiparine during feeding is not recommended.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

There is no data on the effect of Fraxiparine on the ability to drive vehicles and other mechanisms.

Overdose

Symptoms: bleeding. In such cases, platelet count and other coagulation parameters should be determined. Minor bleeding rarely requires special intervention.

Treatment: slow intravenous administration of protamine sulfate is indicated. 0.6 ml of protamine sulfate neutralizes about 1.0 ml of Fraxiparine. It should be taken into account that it is impossible to completely neutralize the anti-Xa factor activity of Fraxiparine. If necessary, it may be necessary to administer the calculated dose in several doses (2-4) during the day.

Release form and packaging

0.4 ml is placed in glass, graduated, siliconized syringes with a capacity of 1 ml, equipped with a stainless steel injection needle attached to the syringe barrel and protected by a rubber cap. 2 pre-filled syringes are placed in PVC blister packs, covered with transparent plastic film. 5 contour packages together with instructions for use in the state and Russian languages ​​are placed in cardboard box.

Storage conditions

At a temperature not higher than +30 °C. Do not freeze.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

Aspen Notre Dame de Bondeville

1 rue de l'Abbaye, 76960 Notre Dame de Bondeville, France

Owner registration certificate

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

LifeMed LLP

st. Popova, 9/57 –9, 050040, Almaty, Republic of Kazakhstan.

Phone/fax number: +7 727 328 41 01

pharmaceuticalprice.kz

Fraxiparine - instructions for use, doses, side effects, contraindications

Subcutaneous injection technique

It is preferable to inject with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.

To avoid loss of the drug when using syringes, do not remove air bubbles before injection.

The needle should be inserted perpendicularly, and not at an angle, into the pinched fold of skin, which must be held between the thumb and forefinger until the end of the solution. Do not rub the injection site after injection.

Prevention of thromboembolism

general surgery

The recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) subcutaneously, 2-4 hours before surgery, then Fraxiparine is administered once a day. Treatment is continued for at least 7 days and during the period of risk of thrombosis, until the patient is transferred to an outpatient regimen.

Orthopedic surgeries

Fraxiparine is prescribed subcutaneously, the dosage depends on the patient’s body weight, and is indicated in the table below, at the rate of 38 anti-Xa IU/kg body weight, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine continues to be used once a day during the period of risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

Patients at high risk of thrombosis, usually in intensive care units (respiratory failure and/or respiratory tract infection and/or heart failure)

Fraxiparine is prescribed subcutaneously, 1 time per day. The dose depends on the patient’s body weight and is indicated in the table below. Fraxiparine is used throughout the entire period of risk of thrombosis.

Treatment of unstable angina and non-Q wave myocardial infarction

Fraxiparine is administered subcutaneously 2 times a day (every 12 hours). The duration of treatment is usually 6 days. In clinical studies, patients with unstable angina/non-Q wave myocardial infarction were prescribed Fraxiparine in combination with aspirin at a dose of 325 mg per day.

The initial dose is administered as a single intravenous bolus injection and subsequent doses are administered subcutaneously. The dose depends on the patient’s body weight and is indicated in the table below, at the rate of 86 anti-Xa IU/kg body weight.

Treatment of thromboembolism

When treating thromboembolism, therapy with oral anticoagulants, in the absence of contraindications, should be started as early as possible. Fraxiparine therapy should not be discontinued until the target values ​​of prothrombin time are achieved.

Fraxiparine is prescribed subcutaneously 2 times a day (every 12 hours), the usual course duration is 10 days. The dose depends on the patient’s body weight and is indicated in the table below, at the rate of 86 anti-Xa IU/kg body weight.

Prevention of blood coagulation in the extracorporeal circulation system during hemodialysis

The dose of Fraxiparine should be set for each patient individually, taking into account the technical conditions of dialysis.

Fraxiparine is administered once into the arterial line of the dialysis loop at the beginning of each session. For patients who do not have an increased risk of bleeding, the following initial doses are recommended, depending on body weight, sufficient for a 4-hour dialysis session:

In patients with an increased risk of bleeding, dialysis sessions can be performed using half the dose of the drug.

If the dialysis session lasts longer than 4 hours, additional small doses of Fraxiparine may be administered.

During subsequent dialysis sessions, the dose should be adjusted depending on the observed effects. The patient should be monitored during the dialysis procedure for possible bleeding or signs of thrombus formation in the dialysis system.

Elderly patients

In elderly patients, no dose adjustment is required, with the exception of patients with impaired renal function. Before starting treatment with Fraxiparine, it is recommended to assess renal function.

Kidney failure

Prevention of thromboembolism

In patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min and less than 60 ml/min), no dose reduction is required if Fraxiparine is used to prevent thrombosis. In patients with severe renal failure (creatinine clearance less than 30 ml/min), the dose should be reduced by 25%. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the dose should be reduced by 25%.

Treatment of thromboembolism, prevention of thromboembolism in patients at high risk of thrombus formation (unstable angina and myocardial infarction without a Q wave)

In patients with mild to moderate renal impairment receiving Fraxiparine for the treatment of these diseases, the dose should be reduced by 25%. Fraxiparine is contraindicated in patients with severe renal impairment.

Patients with liver dysfunction

No specific studies have been conducted for this group of patients.

www.lsgeotar.ru

instructions for use, description of the drug and indications for use.

Pharmacological effects: Nadroparin calcium (the active ingredient of Fraxiparin) is considered a low molecular weight heparin, obtained from standard heparin by depolymerization under special conditions. The drug is characterized by pronounced activity against blood clotting factor Xa and weak activity against factor Pa. The Angi-Ha activity (i.e., antiplatelet/anti-platelet adhesion activity) of the drug is more pronounced than its effect on activated partial thromboplastin time (an indicator of blood clotting rate), which distinguishes nadroparin calcium from unfractionated standard heparin. Thus, the drug has antithrombotic activity (preventing the formation of a blood clot) and has a rapid and long-lasting effect.

Fraxiparine - indications for use:

Fraxiparine - method of application:

Prevention of thromboembolic complicationsGeneral surgery. The usual recommended dosage is 0.3 ml of Fraxiparine once a day subcutaneously for at least 7 days. In any case, prophylaxis should be carried out during the period of risk. The first dose is administered 2 to 4 hours before surgery. Orthopedic surgery. The initial dose of Fraxiparine is administered 12 hours before surgery and 12 hours after it. The use of the medicine is continued for at least 10 days. In any case, prophylaxis should be carried out during the period of risk. The dosage depends on the patient’s body weight and is determined according to the table below:

Non-surgical intensive care unit patients

Treatment of thromboembolic complications Fraxiparin is administered subcutaneously twice a day (every 12 hours), often for 10 days. The dosage depends on the patient’s body weight and is determined according to the table below:

Prevention of blood clotting during hemodialysis. Drug dosages are selected individually, taking into account the technical conditions of dialysis. Fraxiparine is often used as a one-time injection into the arterial circuit at the beginning of each procedure. Recommended starting dosages for patients without an increased risk of bleeding are shown in the table below:

Treatment of unstable angina and myocardial infarction without a Q wave on the ECG. It is suggested to use Fraxiparine in combination with aspirin (up to 325 mg per day). The usual duration of treatment is 6 days. The initial dose of Fraxiparine is administered intravenously into a pre-installed venous catheter at a dose of 86 IU anti-Xa/kg, and then the same dose subcutaneously every 12 hours. Recommended dosages of Fraxiparine are shown in the table below:

Fraxiparine - side effects:

Fraxiparine - contraindications:

Fraxiparine - pregnancy:

Interaction with other drugs: During treatment with Fraxiparine, you should not take any other drugs (including those available without a prescription) without first consulting your doctor. Not recommended simultaneous use Fraxiparine with aspirin (except for the treatment of unstable angina and myocardial infarction without a Q wave) and other salicylates, non-steroidal anti-inflammatory drugs without first consulting a doctor. You should inform your doctor if you are taking oral anticoagulants, glucocorticosteroids or dextrans.

Fraxiparine - overdose:

Fraxiparine - release form:

Fraxiparine - storage conditions:

Fraxiparine - synonyms:

Fraxiparine - composition:

Fraxiparine - additionally:

Important! Before using Fraxiparine, you should consult your doctor. This instruction is intended for informational purposes only.

dxline.ru

Trade name of the drug: Fraxiparine

International nonproprietary name:

Dosage form:

Compound

Active substance: calcium nadroparin - 9500 IU anti-factor Xa activity in 1 ml
Excipients: calcium hydroxide solution (or dilute hydrochloric acid) sufficient amount to pH 5.0 - 7.0, water for injection up to 1.0 ml.

• Syringes lo 0.3 ml - 2850 IU anti-factor Xa activity.
• Syringes then 0.4 ml - 3800 IU anti-factor Xa activity.
• Syringes LO 0.6 ml - 5700 IU anti-factor Xa activity.
• Syringes then 0.8 ml - 7600 IU anti-factor Xa activity.
• Syringes LO 1.0 ml - 9500 IU anti-factor Xa activity.

Description: transparent or slightly opalescent, colorless or light yellow solution.

Pharmacotherapeutic group:

ATX code: B01A B06

Pharmacological properties

Mechanism of action
Nadroparin calcium is a low molecular weight heparin (LMWH) obtained by depolymerization from standard heparin. It is a glycosaminoglycan with an average molecular weight of approximately 4300 daltons.
Nadroparin exhibits a high ability to bind to the plasma protein antithrombin III (AT III). This binding results in accelerated inhibition of factor Xa. This explains the high antithrombotic potential of nadroparin. Other mechanisms providing the antithrombotic effect of nadroparin. include activation of tissue factor conversion inhibitor (TFPI), activation of fibrinogenesis through direct release of tissue plasminogen activator from endothelial cells and modification of the rheological properties of blood (decreasing blood viscosity and increasing the permeability of platelet and granulocyte membranes).

Pharmacodynamics
Nadroparin is characterized by higher activity against factor Xa compared to activity against factor IIa. It has both immediate and prolonged antithrombotic activity.
Compared with unfractionated heparin, nadroparin has less effect on platelet function and aggregation and has little effect on primary hemostasis.
In prophylactic doses, it does not cause a significant decrease in activated partial thrombin time (aPTT).
During a course of treatment during the period of maximum activity, the aPTT can be extended to a value 1.4 times higher than the standard one. This prolongation reflects the residual antithrombotic effect of nadroparin calcium.

Pharmacokinetics
Pharmacokinetic properties are determined based on changes in anti-Xa factor activity of plasma.
Absorption
After subcutaneous administration, maximum anti-Xa activity (Cmax) is achieved after 35 hours (Tmax).
Bioavailability
After subcutaneous administration, nadroparin is almost completely absorbed (about 88%).
At intravenous administration Maximum anti-Xa activity is achieved in less than 10 minutes, and the half-life (T ½) is about 2 hours.
Metabolism
Metabolism occurs mainly in the liver (desulfation, depolymerization).
Removal
The half-life after subcutaneous administration is approximately 3.5 hours. However, anti-Xa activity persists for at least 18 hours after injection of nadroparin at a dose of 1900 anti-Xa ME.

At-risk groups

Elderly patients
In elderly patients, due to a possible decrease in renal function, the elimination of nadroparin may slow down. Possible renal failure in this group of patients requires evaluation and appropriate dose adjustment.

Indications for use

Prevention of thromboembolic complications:

• for general surgical and orthopedic interventions;
• in patients with a high risk of thrombosis (acute respiratory and/or heart failure in an intensive care unit, unstable angina, myocardial infarction without a Q wave).
• Treatment of thromboembolism.
• Prevention of blood clotting during hemodialysis.

Contraindications

• Hypersensitivity to nadroparin or any other component of the drug;
• A history of thrombocytopenia with the use of nadroparin;
• Signs of bleeding or increased risk of bleeding associated with impaired hemostasis, with the exception of DIC not caused by heparin;
• Organic lesions organs with a tendency to bleed (for example, acute gastric or duodenal ulcers);
• Injuries or surgical interventions on the brain, spinal cord or eyes;
• Intracranial hemorrhage;
• Acute septic endocarditis;
• Severe renal failure (creatinine clearance less than 30 ml/min) in patients receiving Fraxiparine for the treatment of thromboembolism, unstable angina and non-Q wave myocardial infarction;
• Childhood (<18 лет)

Directions for use and doses

Subcutaneous injection technique
It is preferable to inject with the patient lying down, into the subcutaneous tissue of the anterolateral or posterolateral surface of the abdomen, alternately from the right and left sides. Injection into the thigh is allowed.
To avoid loss of the drug when using syringes, do not remove air bubbles before injection.
The needle should be inserted perpendicularly, and not at an angle, into the pinched fold of skin, which must be held between the thumb and forefinger until the end of the solution. Do not rub the injection site after injection.

Prevention of thromboembolism

general surgery
The recommended dose of Fraxiparine is 0.3 ml (2850 anti-Xa ME) subcutaneously, 2-4 hours before surgery, then Fraxiparine is administered once a day. Treatment is continued for at least 7 days and during the period of risk of thrombosis, until the patient is transferred to an outpatient regimen.
Orthopedic surgeries
Fraxiparine is prescribed subcutaneously, the dosage depends on the patient’s body weight, and is indicated in the table below, at the rate of 38 anti-Xa IU/kg body weight, which can be increased to 50% on the 4th postoperative day. The initial dose is prescribed 12 hours before surgery, the 2nd dose - 12 hours after the end of the operation. Further, Fraxiparine continues to be used once a day during the period of risk of thrombosis until the patient is transferred to an outpatient regimen. The minimum duration of therapy is 10 days.

Elderly patients
In elderly patients, dose adjustment is not required, with the exception of patients with impaired renal function. Before starting treatment with Fraxiparine, it is recommended to assess renal function.

Kidney failure

Prevention of thromboembolism: In patients with mild to moderate renal impairment (creatinine clearance >30 ml/min and less than 60 ml/min), no dose reduction is required if Fraxiparine is used for the prevention of thromboembolism. In patients with severe renal failure (creatinine clearance less than 30 ml/min), the dose should be reduced by 25%. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), the dose should be reduced by 25%.
Treatment of thromboembolism, prevention of thromboembolism in patients with a high risk of thrombus formation (unstable angina and non-Q wave myocardial infarction): In patients with mild to moderate renal failure receiving Fraxiparine for the treatment of these diseases, the dose should be reduced by 25%. Fraxiparine is contraindicated in patients with severe renal impairment.

Patients with liver dysfunction

No specific studies have been conducted for this group of patients.

Adverse reactions

The following classification of adverse reactions was used depending on the frequency of occurrence: very often (>1/10), often (>1/100,<1/10), иногда (>1/1000, <1/100), редко (>1/10,000, <1/1000), очень редко (<1/10,000).
From the circulatory and lymphatic system: very often - bleeding of various locations, more often in patients with other risk factors; rarely - thrombocytopenia; very rarely - eosinophilia, reversible after discontinuation of the drug.
From the immune system: very rarely - hypersensitivity reactions (including Quincke's edema and skin reactions).
Metabolic: very rarely - reversible hyperkalemia associated with the ability of heparins to suppress aldosterone secretion, especially in patients at risk.
Hepatobiliary disorders: often - increased levels of liver transaminases, which are usually transient.
From the skin and subcutaneous tissues: very often - the formation of a small subcutaneous hematoma at the injection site. In some cases, the appearance of dense nodules is observed, which does not indicate heparin encapsulation, which disappear after a few days. Very rarely - skin necrosis, usually at the injection site. Necrosis is usually preceded by purpura or an infiltrated or painful erythematous patch, which may or may not be accompanied by general symptoms. In such cases, treatment with Fraxiparine should be stopped immediately.
From the reproductive system: very rarely - priapism.

Overdose

Symptoms
The main sign of overdose with subcutaneous or intravenous administration is bleeding. It is necessary to monitor the number of platelets and other parameters of the blood coagulation system. Minor bleeding does not require special therapy; it is usually sufficient to reduce or delay the subsequent dose of Fraxiparine.
Treatment
The use of protamine sulfate is necessary only in severe cases. Protamine sulfate has a pronounced neutralizing effect on the anticoagulant effects of heparin, but some anti-Xa activity may be restored.
0.6 ml of protamine sulfate neutralizes about 950 anti-Xa ME of nadroparin. The dose of protamine sulfate is calculated taking into account the time elapsed after heparin administration, with a possible reduction in the dose of the antidote.

Interactions with other drugs

The development of hyperkalemia may depend on the simultaneous presence of several risk factors. Drugs that cause hyperkalemia: potassium salts, potassium-sparing diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers, nonsteroidal anti-inflammatory drugs, heparins (low molecular weight or unfractionated), cyclosporine and tacrolimus, trimethoprim. The risk of developing hyperkalemia increases when the above-mentioned drugs are combined with Fraxiparine.
The combined use of Fraxiparine with drugs that affect hemostasis, such as acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), vitamin K antagonists, fibrinolytics and dextran, leads to a mutually enhanced effect.
In addition, you should take into account:
platelet aggregation inhibitors (except for acetylsalicylic acid as an asthmatic and antipyretic drug, i.e. in a dose over 500 mg; NSAIDs): abciximab, acetylsalicylic acid in antiplatelet doses (50-300 mg) for cardiac and neurological indications, beraprost, clopidogrel , eptifibatide, iloprost, ticlopidine, tirofiban, increase the risk of bleeding.
Fraxiparine should be prescribed with caution to patients receiving oral anticoagulants, systemic glucocorticosteroids and dextrans. When prescribing oral anticoagulants to patients receiving Fraxiparine, its use should be continued until the prothrombin time stabilizes to the required value.

special instructions

Particular attention should be paid to the specific instructions for use for each drug belonging to the low molecular weight heparin class. because they may use different dosage units (IU or mg). As a result, alternating Fraxiparine with other LMWHs during long-term treatment is unacceptable. It is also necessary to pay attention to which particular drug is used Fraxiparine or Fraxiparine Forte, because this affects the dosage regimen. Graduated syringes are designed to select the dose depending on the patient’s body weight.
Fraxiparine is not intended for intramuscular administration.
During treatment with Fraxiparine, clinical monitoring of platelet count measurements should be carried out. Thrombocytopenia
Since when using heparins there is a possibility of developing thrombocytopenia (heparin-induced thrombocytopenia), platelet levels must be monitored during the entire course of treatment with Fraxiparin.
Rare cases of thrombocytopenia, sometimes severe, have been reported, which may be associated with arterial or venous thrombosis, which is important to consider in the following cases:

• with thrombocytopenia;
• with a significant decrease in platelet levels (by 30 - 50% compared to normal values);
• with negative dynamics of thrombosis for which the patient is receiving treatment;
• with DIC syndrome.

• in patients already receiving anticoagulants, the need for spinal or epidural anesthesia must be justified;
• in patients planning elective surgery using spinal or epidural anesthesia, the need for anticoagulants should be justified.

Release form

0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml or 1.0 ml of the drug in a single-dose glass syringe with a protective housing, a tip with a stainless steel needle, closed with a cap. 2 syringes are packed in a blister made of PVC/specially impregnated paper. 1 or 5 blisters (2 or 10 syringes each) along with instructions for use are placed in a cardboard box.

Storage conditions

List B
Store at a temperature not exceeding 30°C. Do not freeze. Keep out of the reach of children.

Best before date

3 years.
Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies: