"Encepur" - vaccination against tick-borne encephalitis. Encepur for children instructions for use, contraindications, side effects, reviews Encepur for children instructions for use

Owner registration certificate:
NOVARTIS VACCINES AND DIAGNOSTICS GmbH & Co.KG

ATX code for ENCEPUR CHILDREN

J07BA01 (Encephalitis, tick borne, inactivated, whole virus)

Analogues of the drug according to ATC codes:

Before using ENCEPUR CHILDREN you should consult your doctor. These instructions for use are for informational purposes only. To get more complete information Please refer to the manufacturer's instructions.

Clinical and pharmacological group

Release form, composition and packaging

The suspension for intramuscular administration is whitish, opaque, without foreign inclusions.

Excipients: trishydroxymethylaminomethane, sodium chloride, sucrose, aluminum hydroxide, water for injection; does not contain preservatives.

0.25 ml (1 dose) - disposable glass syringes (1) with a needle - blisters (1) - cardboard packs.

* propagated on chicken embryo cell culture, inactivated, purified.

pharmachologic effect

Based on the results of clinical studies, the following intervals for revaccination should be used:

For children vaccinated according to the traditional schedule (schedule A), the following intervals are recommended.

For children vaccinated under the emergency schedule (scheme B), the following intervals are recommended.

Introduction rules

Immediately before administration, the vaccine must be shaken well.

The vaccine is administered intramuscularly, preferably in the forearm area (deltoid muscle).

If necessary (for example, patients hemorrhagic diathesis) the vaccine can be administered subcutaneously.

The vaccine cannot be administered intravenously.

Incorrect intravenous administration of the vaccine can cause reactions including shock. In such cases, anti-shock therapy must be carried out immediately.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examination of the vaccinated person with mandatory thermometry, studies medical card the person being vaccinated. The doctor is responsible for ensuring that the vaccination is prescribed correctly.

The vaccination performed is recorded in the established registration forms, indicating the date of vaccination, dose, name of the vaccine, manufacturer, batch number, expiration date, reaction to the vaccine.

Only a full course of vaccination provides reliable protection.

Vaccination
Dose
Scheme A
First vaccination
0.25 ml
0 day
Second vaccination
0.25 ml
After 1-3 months
Third vaccination
0.25 ml
9-12 months after the second vaccination
Vaccination
Dose
Scheme B
First vaccination
0.25 ml
0 day
Second vaccination
0.25 ml
in 7 days
Third vaccination
0.25 ml
in 21 days
First revaccination
All subsequent revaccinations
3 years
every 5 years
First revaccination
All subsequent revaccinations
in 12-18 months
every 5 years

Overdose

Data on overdose of the Encepur® vaccine for children are not provided.

Drug interactions

Simultaneous administration of the Encepur® children's vaccine and other vaccines with separate syringes into different parts of the body is allowed.

In patients receiving immunosuppressive therapy, vaccination may be less effective.

After administration of immunoglobulin against tick-borne encephalitis Encepur® vaccination for children should be carried out no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

ENCEPUR FOR CHILDREN: SIDE EFFECTS

When assessing the side effects of the drug, the following frequency data were used as the basis: very often - ≥ 10%; often - from 1% to 10%; sometimes - from 0.1% to 1%, rarely - from 0.01% to 0.1%, very rarely -

Based on clinical trial data and results clinical use vaccines, the following information was obtained on the frequency of side effects encountered:

Local reactions in the injection area: very often - transient pain at the injection site; often - redness, swelling; very rarely - granuloma at the site of drug administration, as an exception with the formation of a tumor-like accumulation of blood serum in the tissues.

Systemic reactions: very often (in children from 1 to 2 years old) - increased body temperature ≥ 38°C; often - general malaise, flu-like symptoms (sweating, chills), increased body temperature ≥ 38°C (most often after the first vaccination in children from 3 to 11 years).

From the outside digestive system: often - nausea; rarely - vomiting, diarrhea.

From the musculoskeletal system: often - arthralgia and myalgia; very rarely - arthralgia and myalgia in the occipital area. Arthralgia and myalgia in the neck area can present a picture of meningism. Such symptoms are rare and disappear within a few days without consequences.

From the immune system: very rarely - lymphadenopathy (damage/enlargement of the lymph nodes).

From the central nervous system and peripheral nervous system: very often - drowsiness in children under 3 years of age; often - headache in children over 3 years of age; very rarely - paresthesia (for example, itching, numbness of the extremities), convulsions with increased body temperature.

Allergic reactions: very rarely - generalized allergic rash, swelling of the mucous membranes, laryngeal edema, dyspnea, bronchospasm, hypotension, short-term thrombocytopenia.

Flu-like symptoms occur most often after the first vaccination and usually disappear after 72 hours. If necessary, it is recommended to use anti-inflammatory and antipyretic drugs.

There have been reports that in isolated cases, after vaccination against tick-borne encephalitis, diseases of the central and peripheral nervous system occurred, including ascending paralysis (Guillain-Barré syndrome).

Storage conditions and periods

The vaccine should be stored and transported at a temperature of 2° to 8°C; do not freeze. Keep out of the reach of children. Shelf life - 24 months. Do not use after the expiration date stated on the package.

Indications

• active prevention of tick-borne encephalitis in children aged 1 to 11 years inclusive.

From the age of 12, the vaccine is indicated for use in adults.

Vaccination is indicated for persons permanently residing or temporarily staying in areas where tick-borne encephalitis is endemic. Vaccination can be carried out year-round, including the epidemic season of tick-borne encephalitis.

Contraindications

• acute febrile conditions of any etiology or exacerbation of chronic infectious diseases.
• Vaccination is carried out no earlier than
• less than 2 weeks after symptoms disappear acute illness(normalization of body temperature);
• the presence of allergic reactions to vaccine components.

If a complication occurs after vaccination, it should be considered as a contraindication for further vaccination with the same vaccine until the cause of the complication is determined. This is especially important for adverse reactions that are not limited to the injection site.

special instructions

As a rule, there is no increased risk when immunizing children with Encepur® vaccine allergic reactions for chicken protein or a positive skin reaction to ovalbumin.

In extremely rare cases, when such patients experienced clinical symptoms such as rash, swelling of the lips and epiglottis, laryngo- or bronchospasm, hypotension or shock, the vaccine should be administered only under close clinical supervision and in a room equipped with anti-shock therapy.

The need for vaccination of persons with a history of brain lesions should be carried out after the conclusion of a neurologist.

Persons with a history of the following diseases or conditions are vaccinated strictly as prescribed by the doctor:

• common infection
• especially if there is an increase in body temperature of more than 38°C;
• family history of seizures;
• febrile seizures (in persons
• in this case, it is advisable for those subject to vaccination to be prescribed antipyretic drugs immediately before the administration of the vaccine,
• and also 4 hours and 8 hours after vaccination);
• eczema and others skin diseases,
• localized infectious skin lesions;
• during treatment with antibiotics or corticosteroids,
• incl.
• in small doses,
• as well as with local use of drugs,
• containing steroids;
• non-progressive lesions of the central nervous system;
• congenital or acquired immunodeficiencies;
• chronic diseases internal organs,
• systemic chronic diseases.

If necessary, these patients can be prescribed therapy appropriate to the underlying disease.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Registration numbers

susp. intramuscular injection 0.75 mcg/1 dose: syringes 0.25 ml 1 pc. with needle P N015312/01 (2002-04-09 – 0000-00-00)

Experimental determination of suitable drugs:

• VACCINE FOR PREVENTION…

Active substance

Antigen of tick-borne encephalitis virus (vaccinum encephalitidis ixodicae (inactivatum culturale))

Release form, composition and packaging

Suspension for intramuscular administration opaque, whitish in color, without foreign inclusions.

Excipients: trishydroxymethylaminomethane, sucrose, aluminum hydroxide, water for injection; does not contain preservatives.

0.5 ml - disposable glass syringes with needles (1) - blisters (1) - cardboard packs.

* propagated on chicken embryo cell culture, inactivated, purified.

pharmachologic effect

Vaccine against. Antibody titers to the tick-borne encephalitis virus are detected in all vaccinated people after the full course of primary immunization.

When immunizing according to scheme A:

4 weeks after the first vaccination (day 28) - in 50% of vaccinated people;

2 weeks after the second vaccination (day 42) - in 98% of vaccinated people;

2 weeks after the third vaccination (day 314) - in 99% of vaccinated people.

When using scheme B - emergency vaccination, the protective level of antibodies is achieved after 14 days:

after the second vaccination (21 days) - in 90% of vaccinated people;

after the third vaccination (day 35) - in 99% of vaccinated people.

Indications

- active prevention of tick-borne encephalitis in adults and adolescents from the age of 12.

Vaccination is indicated for persons permanently residing or temporarily staying in areas where tick-borne encephalitis is endemic. Vaccination can be carried out year-round.

Contraindications

- acute febrile conditions of any etiology or exacerbation of chronic infectious diseases. Vaccination is carried out no earlier than 2 weeks after the disappearance of symptoms of an acute disease (normalization of body temperature);

— presence of allergic reactions to vaccine components.

If a complication occurs after vaccination, it should be considered as a contraindication for further vaccination with the same vaccine until the cause of the complication is determined. This is especially important for adverse reactions that are not limited to the injection site.

Dosage

Primary course of vaccination

Primary vaccination is carried out using scheme A (traditional scheme).

The second dose may be given 14 days after the first dose.

The traditional scheme is preferable for persons located in endemic areas.

After completion of vaccination, protective antibody titers persist for at least 3 years, after which revaccination is recommended.

Seroconversion develops no earlier than 14 days after the second vaccination.

If rapid (emergency) vaccination is required, regimen B is used.

Seroconversion develops no earlier than 14 days after the second vaccination, i.e. 21 days. After completion of vaccination, the protective antibody titer persists for 12-18 months, after which revaccination is recommended.

In immunocompromised individuals and those aged 59 years and older, antibody levels should be checked between 30 and 60 days after the second vaccination with schedule A and the third vaccination with schedule B and, if necessary, additional vaccinations should be given.

Revaccination

After a course of primary vaccination carried out according to one of two schemes, one injection of 0.5 ml of Encepur vaccine for adults is sufficient to maintain strong immunity. Based on the results of clinical studies, the following intervals for revaccination should be used.

For persons who received primary vaccination according to the routine vaccination schedule (schedule A), it is recommended to use the following intervals.

For persons who received primary vaccination according to the emergency regimen (scheme B), it is recommended to use the following intervals.

Introduction rules

Immediately before administration, the vaccine in the syringe must be shaken well.

The vaccine is administered intramuscularly, preferably in the area of ​​the upper third of the shoulder (deltoid muscle). If necessary (for example, in patients with hemorrhagic diathesis), the vaccine can be administered subcutaneously.

The vaccine cannot be administered intravenously!

Incorrect intravenous administration of the vaccine can cause allergic reactions up to. In such cases, anti-shock therapy must be carried out immediately.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examination of the vaccinated person with mandatory thermometry, and studies the medical record of the vaccinated person. The doctor is responsible for ensuring that the vaccination is prescribed correctly.

The vaccination performed is recorded in the established registration forms, indicating the date of vaccination, dose, name of the vaccine, manufacturer, batch number, expiration date, reaction to the vaccine.

Only a full course of vaccination provides reliable protection.

Side effects

When assessing the side effects of the drug, the following frequency data were used as the basis: very often - ≥ 10%; often - from 1% to 10%; sometimes - from 0.1% to 1%, rarely - from 0.01% to 0.1%, very rarely -< 0.01%, включая единичные случаи.

Based on data obtained during clinical trials and the results of clinical use of the vaccine, the following information was obtained on the frequency of adverse events encountered:

Local reactions in the injection area: very often - passing pain; often - redness, swelling; very rarely - granuloma at the site of drug administration, as an exception with the formation of a tumor-like accumulation of blood serum in the tissues.

Systemic reactions: very often - general malaise; often - flu-like symptoms (sweating, chills), most often after the first vaccination, increased body temperature ≥ 38°C.

From the digestive system: often - nausea; rarely - vomiting; very rarely - diarrhea.

From the musculoskeletal system: often - arthralgia and myalgia; very rarely - arthralgia and myalgia in the occipital area.

From the immune system: very rarely - lymphadenopathy.

From the central nervous system and peripheral nervous system: Often - ; very rarely - paresthesia (for example, itching, numbness of the extremities).

Allergic reactions: very rarely - generalized allergic rash, swelling of the mucous membranes, laryngeal edema, dyspnea, bronchospasm, hypotension, short-term thrombocytopenia.

Flu-like symptoms occur most often after the first vaccination and usually disappear after 72 hours. If necessary, it is recommended to use anti-inflammatory therapeutic agents.

Arthralgia and myalgia in the neck area can present a picture of meningism. Such symptoms are rare and disappear within a few days without consequences.

There have been reports that in isolated cases, after vaccination against tick-borne encephalitis, diseases of the central and peripheral nervous system occurred, including ascending paralysis (Guillain-Barré syndrome).

Overdose

Data on overdose of the Encepur vaccine for adults are not provided.

Drug interactions

Simultaneous administration of the Encepur adult vaccine and other vaccines with separate syringes into different parts of the body is allowed.

In patients receiving immunosuppressive therapy, vaccination may be less effective.

After administration against tick-borne encephalitis, the Encepur vaccine should be administered to adults no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

special instructions

As a rule, there is no increased risk when immunizing adults with the Encepur vaccine in individuals who have an allergic reaction to chicken protein or a positive skin reaction to ovalbumin.

In the extremely rare cases where clinical symptoms such as rash, swelling of the lips and epiglottis, laryngo- or bronchospasm, hypotension or shock have been observed in such patients, the vaccine should be administered only under close clinical supervision and in a room equipped with anti-shock therapy.

The need for vaccination in persons with a history of brain lesions must be determined very carefully.

For persons with the following diseases, vaccination can be carried out simultaneously with the appointment drug treatment appropriate this disease:

- family history of seizures;

- febrile convulsions (in this case, it is advisable for persons subject to vaccination to be prescribed antipyretic drugs immediately before the administration of the vaccine, as well as 4 hours and 8 hours after vaccination);

- eczema and other skin diseases, localized skin lesions;

- treatment with antibiotics or corticosteroids, incl. in small doses, as well as with local use of drugs containing steroids;

- non-progressive lesions of the central nervous system;

— congenital or acquired immunodeficiencies;

— chronic diseases of internal organs, systemic chronic diseases.

Shelf life - 24 months. Do not use after the expiration date stated on the package.

J.07.B.A Vaccine to prevent encephalitis

J.07.B.A.01 Tick-borne encephalitis virus - inactivated whole

The disease tick-borne encephalitis is very dangerous for both children and adults. In addition, it is quite common in Russia. This is due to our climatic conditions, which are favorable for the reproduction of the virus. You can meet encephalitis-carrying ticks in any region except the far north, depending on the season. A significant proportion of those bitten and infected are children.

1–2% of patients die, up to 20% get irreversible neurological complications. In endemic areas, routine vaccination against tick-borne encephalitis is required. And if quick protection is needed, emergency vaccination is required. Several such vaccines are registered in Russia. "Entsepur" is one of them. Let's take a closer look at how it works, when and in what cases it is used.

What kind of vaccine is Encepur?

Encepur is a vaccine that creates specific immunity against tick-borne encephalitis. Two types of this vaccination are registered: adult and children. The only difference is the dosage. The adult Encepur was registered in Russia in 1999. Following it in 2004, a children's version appeared on the Russian market.

"Encepur" contains only antigens of the Siberian and Far Eastern subtypes of the encephalitis virus. The vaccine is inactivated. In children's "Encepur" there are 0.75 mcg of antigens, in adults - 1.5 mcg. The lower the dose of administered antigens, the lower the likelihood of adverse reactions.

The Encepur tick-borne encephalitis vaccine does not contain polygeline and human albumin, which are sometimes added to other vaccines as a stabilizer. Therefore, the allergenicity of the vaccine is lower than that of some analogues. In addition, the risk of infection is eliminated dangerous infections(AIDS, hepatitis, etc.). This drug meets all WHO requirements.

The Encepur vaccine against tick-borne encephalitis has been clinically studied and has studies that were conducted in Russia. The effectiveness of the drug against virus variants in the Primorsky Territory was studied. There is confirmation of the high effectiveness of the vaccine against it. It's approaching 100%.

The safety of the vaccine was also studied. For 14 years there has not been a single case of post-vaccination encephalitis caused by Encepur.

The manufacturer of Encepur is the German company Vaccines and Diagnostics GmbH & Co. KG".

This vaccination is indicated:

• adults and children living in endemic (with high risk infection) in tick-borne encephalitis areas;
• children and adults temporarily visiting endemic areas.

Instructions and immunization schedules "Encepur"

The Encepur vaccination against tick-borne encephalitis is given according to two vaccination schemes: administration for emergency or planned prophylaxis.

When should you get Encepur vaccinations against tick-borne encephalitis? Routine immunization is carried out using a three-time injection of the vaccine.

1. The first vaccination is administered in a standard dose. Immunity after it occurs in 50% of vaccinated people after 2 weeks.
2. The second one is placed after 1–3 months, but the instructions for the drug allow it to be done earlier, after 14 days. Immunity after the second vaccine occurs in 98% of vaccinated people after 2 weeks.
3. The third vaccination is the last. It is placed 9–12 months after the second. The number of vaccinated people with full immunity is 99%.

Who is this scheme suitable for? It is better to adhere to it for everyone who lives in areas where the disease is endemic, in order to certainly exclude infection. After any stage of vaccination according to this scheme, immunity develops only on day 42.

The validity period of the Encepur vaccination against tick-borne encephalitis is about three years.

When to get vaccinated if you need quick protection? If you are planning to visit a forest in an endemic zone, and the time for routine vaccination has already been missed, then a more rapid increase in the number of protective agents is required. An emergency protection scheme has been developed for this purpose. In this case, vaccinations are also given three times, the only difference is when they are administered.

With this vaccination schedule, after the second administration, immunity is detected in 90% of vaccinated people, and after the third - in 99%. The required amount of antibodies appears on the 21st day from the start of vaccination.
The number of protective bodies remains for up to 18 months.

Revaccination is carried out with a single administration of one dose of the drug, depending on the scheme of the initial course. It also depends on the age of the person. After scheduled vaccination, revaccination is carried out:

• in persons from 12 to 49 years old after 3 years, then every 5 years;
• people over 49 years old every 3 years.

After emergency prevention:

• for persons from 12 to 49 years old - after one, maximum one and a half years, then every 5 years;
• people over 49 years old - also after one, maximum one and a half years, then every 3 years.

Such schemes are provided for in the instructions for adults "Entsepur".

Vaccination of children

When should a child be vaccinated? The instructions for children's "Entsepur" allow children from 1 year of age to be vaccinated as planned.
The vaccination schedule is as follows:

If vaccination is required for a child under one year of age, this can be done if necessary.

Where is the Encepur tick-borne encephalitis vaccine given? It is injected into a muscle, the deltoid is best suited.

Contraindications and side effects

There are contraindications for the Encepur tick-borne encephalitis vaccination. The vaccine is temporarily contraindicated for those who have colds or other diseases in the acute phase. Vaccination is postponed for a month after recovery.

TO absolute contraindications relate:

• severe allergic reaction to previous injections;
• chicken egg allergy;
• heavy adverse reactions at the first injections.

The Encepur vaccine is not contraindicated for pregnant women. But its effect in this group of patients has not been studied. Therefore, it is better to evaluate all the pros and cons and do it only if it is absolutely necessary.

Due to the absence of certain proteins, the vaccine is well tolerated. What complications can occur after Encepur vaccination?

1. Local manifestations: redness, infiltration - disappear on their own after some time.
2. General malaise, sweating, fever - may appear in 1-10% of vaccinated people, disappear within 3 days.
3. Nausea, less often vomiting. Diarrhea is very rare.
4. Headache occurs frequently. But numbness of the limbs is very rare.
5. Allergic reactions from itching and rash to angioedema and anaphylactic shock.
6. Rarely, there may be pain in the joints, muscles, and swollen lymph nodes.
7. IN clinical practice In isolated cases, ascending paralysis was reported after the administration of Encepur. Therefore, people with brain damage should be vaccinated very carefully.

"Entsepur" interacts well with others medicinal substances. But they cannot be administered in the same syringe. Can be done on different limbs.

Vaccination is not carried out after the tick has already bitten. If immunoglobulin was administered before, then Encepur is postponed for at least 2 weeks. Antigens in the vaccine can bind immunoglobulins and reduce their concentration in the blood, and therefore reduce effectiveness.

Vaccines analogous to "Encepur"

"Entsepur" has analogues:

• Russian "Entsevir";
• culture-purified tick-borne encephalitis vaccine (Russia);
• Russian "Klesch-E-Vac";
• Austrian “FSME-Immun Inject” (adult);
• Austrian "FSME-Immun Junior" (children).

Imported drugs differ from Russian ones in the degree of purification and safety. They have fewer contraindications and side effects.

When to vaccinate against tick-borne encephalitis

"Encepur" has the shortest development time for emergency protection. They are only 21 days. You need to protect yourself from ticks, even if you have been fully immunized with this vaccine. After all, Encepur only protects against its own virus, but there are many other diseases that are transmitted by ticks.

It is best to start vaccination with Encepur in the fall.

Let's summarize. "Encepur" provides protection from dangerous disease tick-borne encephalitis. This imported vaccine forms immunity in almost all vaccinated people after full immunization. There are two vaccination schedules that differ in timing. Routine vaccinations will build immunity on day 42, and emergency immunization will build immunity after 21 days. The rapid formation of protection is indicated for those who did not have time to get vaccinated as planned. "Encepur" forms emergency immunity faster than its analogues. The vaccine is valid for 3 to 5 years. Vaccination is not given if the tick has already bitten. It has few contraindications and is well tolerated. Children's "Entsepur" can be taken from the age of 1 year.

Latest update of the description by the manufacturer 01.09.2014

Filterable list

Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

Compound

Encepur adult

Encepur for children

pharmachologic effect

Directions for use and doses

V/m, preferably in the area of ​​the upper third of the shoulder (deltoid muscle). If necessary (for example, patients with hemorrhagic diathesis), the vaccine can be administered PC.

Cannot be administered intravenously.

Incorrect intravenous administration of the vaccine can cause allergic reactions, including shock. In such cases, anti-shock therapy must be carried out immediately.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examination of the vaccinated person with mandatory thermometry, and studies the medical record of the vaccinated person. The doctor is responsible for ensuring that the vaccination is prescribed correctly. The vaccination performed is recorded in the established registration forms, indicating the date of vaccination, dose, name of the vaccine, manufacturer, batch number, expiration date, reaction to the vaccine.

Only a full course of vaccination provides reliable protection.

Immediately before administration, the syringe with the vaccine must be shaken well.

Primary course of vaccination

Primary vaccination is carried out using scheme A (traditional scheme).

Table 1

The second dose may be given 14 days after the first dose.

The traditional scheme is preferable for persons located in endemic areas.

Seroconversion develops no earlier than 14 days after the second vaccination.

After completion of vaccination, protective antibody titers persist for at least 3 years, after which revaccination is recommended.

If rapid (emergency) vaccination is required, schedule B is used.

table 2

Seroconversion develops no earlier than 14 days after the second vaccination, i.e. on the 21st day. After completion of vaccination, the protective antibody titer persists for 12-18 months, after which revaccination is recommended.

In those who are immunocompromised and 59 years of age or older, antibody levels should be checked between 30 and 60 days after the 2nd vaccination of schedule A and the 3rd vaccination of schedule B and, if necessary, an additional vaccination should be given.

Revaccination

After a course of primary vaccination, carried out according to one of two schemes, one injection is sufficient to maintain strong immunity. Based on the results of clinical studies, the intervals for revaccination indicated in Table 3, 4 should be used.

For individuals who have received their primary vaccination using the routine vaccination schedule (Schedule A), the following intervals are recommended.

Table 3

For persons vaccinated under the emergency schedule (Schedule B), the following intervals are recommended.