Encepur vaccination series and dose. Medicinal reference book geotar. Adverse reactions

J.07.B.A Encephalitis vaccine

J.07.B.A.01 TBE virus - inactivated whole

Vaccine against tick-borne encephalitis, inactivated, purified with adjuvant.

Registration number:

Dosage form:

Composition:

Description: Opaque suspension of whitish color without extraneous inclusions.

Pharmacotherapeutic group:

ATC code:

Indications:
Active prevention of tick-borne encephalitis (TBE) in adults and adolescents from 12 years of age. Vaccination is indicated for persons permanently residing or temporarily staying in areas endemic for tick-borne encephalitis. Vaccination can be carried out all year round.
Immunobiological properties:
Titers of antibodies to the TBE virus are detected in all vaccinated after a full course of primary immunization.
When immunized according to scheme A: 4 weeks after the first vaccination (day 28): in 50% of those vaccinated
2 weeks after the second vaccination (Day 42): 98% of those vaccinated
2 weeks after 3rd vaccination (day 314): in 99% of those vaccinated.
When using regimen B - emergency vaccination, a protective level of antibodies is reached after 14 days.
After the second vaccination (day 21) in 90% of the vaccinated. After the third vaccination (day 35) in 99% of the vaccinated.

Contraindications:

1. Acute febrile conditions of any etiology. or exacerbation of chronic infectious diseases. Vaccinations are carried out no earlier than 2 weeks after the disappearance of signs of an acute illness (normalization of body temperature);
2. The presence of an allergy to the components of the vaccine;

Method of application and dosage:
a) Primary vaccination course.
Primary vaccination is carried out using scheme A (traditional scheme).

Side effect
When evaluating the side effects of the drug, the following frequency data were used as the basis:
Very common >10%
Often 1 to 10%
Occasionally from 0.1 to 1%
Rarely 0.01 to 0.1%
Very rare Based on data obtained from clinical studies and the results of clinical use of the vaccine, the following information was obtained on the frequency of side effects:
Local reactions at the injection site
Often: passing pains
Often: redness, swelling Very rarely: granuloma at the injection site, as an exception with the formation of a tumor-like accumulation of blood serum in the tissues.
Systemic reactions
Very common: general malaise
Common: Flu-like symptoms (sweating, chills), most common after first vaccination, fever >38°C
gastrointestinal tract
Common: nausea
Rare: vomiting
Very rare: diarrhea
Muscles and joints:
Common: arthralgia and myalgia
Very rare: arthralgia and myalgia in the neck
Circulation and lymphatic system
Very rare: lymphadenopathy
Nervous system:
Very common: headache
Very rare: paresthesia (eg, itching, numbness of the extremities).
The immune system
Very rare: allergic reactions (generalized allergic rash, mucosal edema, laryngeal edema, dyspnea, bronchospasm, hypotension, transient thrombocytopenia).
Influenza-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 may represent a picture of meningism. Such symptoms are rare and disappear within a few days without consequences.
There were reports that in isolated cases, after vaccination against TBE, there were diseases of the central and peripheral nervous system, including ascending paralysis (Guillain-Barré syndrome).

Pregnancy and lactation:
Clinical studies of the safety of the vaccine Encepur Adult for pregnant and lactating women have not been conducted.
Vaccination of pregnant and lactating women can only be carried out after a careful assessment of the risk of their possible infection with the TBE virus.

Caveats:
In general, there is no increased risk of vaccination with Encepur Adult in individuals who are considered "allergic to chicken protein" or who have a positive skin reaction to ovalbumin.
In the exceptionally rare cases in which such patients have experienced clinical symptoms such as rash, swelling of the lips and/or epiglottis, lagingo-or bronchospasm, hypotension or shock, the vaccine should only be administered under close clinical supervision in a room provided with anti-shock therapy.
The need for vaccination in persons with a history of brain damage must be determined very carefully.
Persons with the following diseases:

• family history of seizures
• febrile convulsions(For persons to be vaccinated, it is advisable in this case to prescribe antipyretics immediately before the introduction of the vaccine, as well as 4 and 8 hours after vaccination).
• eczema and other skin conditions, localized skin infection,
• treatment with antibiotics or low doses of corticosteroids or topical use of drugs containing steroids,
• non-progressive CNS lesions,
• congenital or acquired immunodeficiencies,
• chronic diseases internal organs, systemic diseases,

Interaction with others medicines:
Simultaneous vaccination of Encepur adult and the introduction of other vaccines with separate syringes into different parts of the body are allowed. In patients receiving immunosuppressive therapy, vaccination may be less effective.
After the introduction of immunoglobulin against tick-borne encephalitis, vaccination of Encepur adult should be carried out no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

Package.
0.5 ml (1 dose) in a sterile hydrolytic class glass syringe, type I (Eur. Pharm.) with a needle closed with a rubber cap. One syringe with a needle in a blister (PVC). One blister with instructions for use in a cardboard pack.
Transportation.
All types of covered transport at a temperature of 2 to 8°C. Do not freeze!

Storage.
Store at a temperature of 2 to 8 °C. Do not freeze! Keep out of the reach of children!

Best before date.
24 months. Do not use after the expiry date stated on the package.

Holiday conditions. Released by prescription.

Manufacturer:

Active substance

Tick-borne encephalitis virus antigen (vaccinum encephalitidis ixodicae (inactivatum culturale))

Release form, composition and packaging

Suspension for intramuscular injection opaque, whitish 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 in chick embryo cell culture, inactivated, purified.

pharmachologic effect

Vaccine against. Titers of antibodies to tick-borne encephalitis virus are detected in all vaccinated after a full course of primary immunization.

When immunized according to scheme A:

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

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

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

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

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

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

Indications

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

Vaccination is indicated for persons permanently residing or temporarily staying in areas endemic for tick-borne encephalitis. Vaccination can be carried out all 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 the symptoms of an acute illness (normalization of body temperature);

- the presence of allergic reactions to the components of the vaccine.

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

Dosage

Primary vaccination course

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

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

The traditional scheme is preferred for individuals in endemic areas.

After completion of vaccination, a protective antibody titer is maintained for at least 3 years, after which it is recommended to revaccinate.

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

If rapid (emergency) vaccination is required, scheme B is applied.

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 it is recommended to revaccinate.

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

Revaccination

After a course of primary vaccination, carried out according to one of the two schemes, one injection of 0.5 ml of Encepur adult vaccine is sufficient to maintain a strong immune system. Based on the results of clinical trials, the following booster intervals should be used.

For individuals who have received primary vaccination according to the routine vaccination schedule (Scheme A), the following intervals are recommended.

For individuals who received primary vaccinations under the emergency scheme (Schedule B), the following intervals are recommended.

Introduction rules

Shake the syringe well before administering it.

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

The vaccine must not be administered intravenously!

Erroneous intravenous administration of the vaccine can cause allergic reactions up to. In such cases, it is necessary to immediately conduct anti-shock therapy.

On the day of vaccination, the doctor (or paramedic) conducts a survey and examination of the vaccinated with obligatory thermometry, studies the medical record of the vaccinated. The doctor is responsible for the correct appointment of the vaccine.

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

Only a full course of vaccination provides reliable protection.

Side effects

When evaluating the side effects of the drug, the following frequency data were based on: 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 the data obtained during clinical studies and the results of the clinical use of the vaccine, the following information was obtained on the frequency of side effects:

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

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

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

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

From the side immune system: very rarely - lymphadenopathy.

From the side of 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, mucosal edema, laryngeal edema, dyspnea, bronchospasm, hypotension, short-term thrombocytopenia.

Influenza-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 may represent 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, including ascending paralysis (Guillain-Barré syndrome), occurred.

Overdose

Data on overdose of the vaccine Encepur adult are not provided.

drug interaction

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

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

After the introduction of the vaccine against tick-borne encephalitis, the introduction of the Encepur adult vaccine should be carried out no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

special instructions

In general, there is no increased risk when immunized with Encepur Adult vaccine in persons with allergic reactions to chicken protein or a positive skin reaction to ovalbumin.

In the exceptionally rare cases in which such patients have 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 provided with anti-shock therapy.

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

Persons with the following diseases can be vaccinated simultaneously with the appointment of drug treatment appropriate for this disease:

- family history of seizures;

- febrile convulsions (for persons to be vaccinated, it is advisable in this case to prescribe antipyretics immediately before the introduction 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 topical 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.

Expiration date - 24 months. Do not use after the expiry date stated on the package.

(Vaccine against tick-borne encephalitis culture inactivated purified liquid with adjuvant)

Dosage form:

Composition:

Description: Opaque suspension of whitish color without extraneous inclusions.

Pharmacotherapeutic group:

ATC code:

Indications:
Active prevention of tick-borne encephalitis (TBE) for children aged 1 to 11 years inclusive. For children from 12 years of age, a vaccine intended for immunization of adults is used.
Vaccination is indicated for persons permanently residing or temporarily staying in areas endemic for tick-borne encephalitis. Vaccination can be carried out all year round, including during the TBE epidemic season.
Immunobiological properties:
Titers of antibodies to the TBE virus are detected in all vaccinated after a full course of primary immunization.
When immunized according to scheme A:
4 weeks after the first vaccination (day 28): in 50% of those vaccinated
2 weeks after the second vaccination (day 42) in 98%
vaccinated 2 weeks after 3rd vaccination(314 days) in 99% of those vaccinated
When using scheme B - emergency vaccination, the protective level of antibodies is reached after 14 days:
After the second vaccination (21 days) in 90% of those vaccinated
After the third vaccination (day 35) in 99% of those vaccinated

Contraindications:

1. Acute febrile conditions of any ethnology or exacerbation of chronic infectious diseases Vaccinations are carried out no earlier than 2 weeks after the disappearance of signs of an acute disease (normalization of body temperature);
2. Allergy to vaccine components

Method of application and dosage:
a) Primary vaccination course. Primary vaccination is carried out using scheme A (traditional scheme).

Side effect
When evaluating the side effects of the drug, the following frequency data were used as the basis:
Very common >10%
Often 1 to 10%
Occasionally from 0.1 to 1%
Rarely 0.01 to 0.1%
Very rare Based on data obtained from clinical studies and the results of clinical use of the vaccine, the following information was obtained on the frequency of side effects:
Local reactions at the injection site
Very common: transient pain at the injection site
Common: redness, swelling
Very rare: granuloma at the injection site, as an exception with the formation of a tumor-like accumulation of blood serum in the tissues
Systemic reactions
Very common: in children aged 1 to 2 years, fever >38°C
Common: general malaise flu-like symptoms (sweating, chills), fever >38°C (most common after first vaccination in children aged 3 to 11 years)
gastrointestinal tract
Common: nausea
Rare: vomiting, diarrhea
Muscles and joints:
Common: arthralgia, myalgia
Very rare: arthralgia and myalgia in the neck
Arthralgia and myalgia in the neck may represent a picture of meningism. These symptoms are rare and disappear within a few days without sequelae.
Circulation and lymphatic system
Very rare: lymphadenopathy (damage/enlargement of lymph nodes)
Nervous system:
Very common: drowsiness in children under three years of age
Common: Headaches in children older than 3 years
Very rare: malaise (eg, itching, numbness of extremities), convulsions with fever
The immune system
Very rare: allergic reactions (for example, generalized allergic rash, mucosal edema, laryngeal edema, dyspnea, bronchospasm, hypotension and other reactions with possible temporary non-specific visual disturbances, transient thrombocytopenia)
Flu-like symptoms are most common after the first vaccination and usually resolve within 72 hours. If necessary, it is recommended to use anti-inflammatory and antipyretic drugs.
There were reports that in isolated cases, after vaccination against TBE, there were diseases of the central and peripheral nervous system, including ascending paralysis (Guillain-Barré syndrome).

Caveats:
In general, there is no increased risk of vaccination with Encepur ® Pediatric in individuals who are considered "allergic to chicken protein" or who have a positive skin reaction to ovalbumin.
In the exceptionally rare cases in which such patients have experienced clinical symptoms such as rash, swelling of the lips and/or epiglottis, lagingo-or bronchospasm, hypotension or shock, the vaccine should only be administered under close clinical supervision in a room provided 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 neuropathologist.
Persons with the following diseases:

• common infection, especially if there is a temperature increase of more than 38 ° C
• family history of seizures
• febrile convulsions (for persons to be vaccinated, it is advisable in this case to prescribe antipyretics immediately before the introduction of the vaccine, as well as 4 and 8 hours after vaccination).
• eczema and other skin conditions, localized skin infection,
• treatment with antibiotics or low doses of corticosteroids or topical use of drugs containing steroids,
• non-progressive CNS lesions,
• congenital or acquired immunodeficiencies,
• chronic diseases of internal organs, systemic diseases, vaccination is carried out strictly according to the doctor's prescription. If necessary, these persons can be prescribed therapy corresponding to the underlying disease.

Interaction with other drugs:
Simultaneous vaccination of Encepur ® for children and the introduction of other vaccines with separate syringes into different parts of the body are allowed.
In patients receiving immunosuppressive therapy, vaccination may be less effective.
After the introduction of immunoglobulin against tick-borne encephalitis, vaccination with Enzeiur ® for children should be carried out no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

Package.
0.25 ml (1 dose) in a sterile disposable syringe made of hydrolytic class glass, type I (Eur. Pharm.) with a needle closed with a rubber cap. A label is glued on the syringe with a marking on which the arrow indicates the detachable part of the label intended for registration of vaccination in medical card One syringe with a needle in a blister (PVC). One blister with instructions for use in a cardboard pack.
Transportation
At temperatures from 2 to 8 °C. Do not freeze.
Storage
At temperatures from 2 to 8 °C. Do not freeze Keep out of the reach of children!

Leave conditions: Released by prescription

Best before date:

Manufacturer: