Medicinal reference book geotar. Encepur children's instructions for use, contraindications, side effects, reviews Encepur vaccination is best to start in the fall

Dosage form:  suspension for intramuscular injection Compound:

One dose (0.5 ml) of the vaccine contains:

active ingredients : tick-borne encephalitis virus antigen (strain K23) propagated in chick embryo cell culture, inactivated, purified, 1.5 μg;

auxiliary components: trishydroxymethylaminomethane 2.55 mg, sodium chloride 2.4 mg, sucrose 20-30 mg, aluminum hydroxide 1 mg, water for injection up to 0.5 ml.

The vaccine does not contain preservatives.

Description:

Opaque suspension of whitish color without extraneous inclusions.

Pharmacotherapeutic group: MIBP - ATH vaccine:  

J.07.B.A Encephalitis vaccine

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

Pharmacodynamics:

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% of those vaccinated;

2 weeks after the 3rd vaccination (314 days): in 99% of the 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.

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.

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 hypersensitivity to the active ingredient, excipients or substances used in the production process, which may be contained in trace amounts (chlortetracycline,).

3. A strong reaction to the previous dose of the vaccine (temperature above 40 ° C, at the injection site - edema and hyperemia over 8 cm in diameter).

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.

Carefully:

In general, there is no increased risk of vaccination with Encepur® Adult in individuals who are considered "allergic to chicken protein" or 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 individuals 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-dose corticosteroids or topical steroids

Non-progressive CNS lesions

Congenital or acquired immunodeficiencies,

Chronic diseases of internal organs, systemic diseases, -

vaccination can be carried out simultaneously with the appointment of drug treatment appropriate to this disease.

Pregnancy and lactation:

Clinical studies on the safety of Encepur® Adult in 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.

Dosage and administration:

a) Primary vaccination course.

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

Vaccination	Dose	Scheme A
First vaccination
Second vaccination		After 1-3 months
Third vaccination		9-12 months after the second vaccination

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, apply scheme B.

Vaccination	Dose	Scheme B
First vaccination
Second vaccination		After 7 days
Third vaccination		After 21 days

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 is maintained for 12-18 months, after which it is recommended to revaccinate.

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

b) Revaccination.

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

For individuals who have received primary vaccination according to the routine vaccination schedule (Scheme A), it is recommended to use the following intervals:

Scheme A (traditional)	First revaccination	Subsequent revaccinations
Age from 12 to 49 years		Every 5 years
Age over 49 years		Every 3 years

For individuals vaccinated under the emergency schedule (Scheme B), the following intervals are recommended.

Scheme B (emergency)	First revaccination	Subsequent revaccinations
Age from 12 to 49 years	After 12-18 months	Every 5 years
Age over 49 years	After 12-18 months	Every 3 years

Method of administration:

Shake the syringe well before administering the vaccine!

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

Do not administer intravenously!

Incorrect intravenous administration of the vaccine can cause allergic reactions up to shock. 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 used as the basis:

Very often - ≥10%

Often - from 1 to 10%

Occasionally - from 0.1 to 1%

Rarely - from 0.01 to 0.1%

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 at the injection site

Very common: transient pain at the injection site.

Often: redness, swelling.

Very rare: granuloma at the injection site, in exceptional cases with the formation of a tumor-like accumulation of blood serum in the tissues.

Systemic reactions

Very common: general malaise.

Often: flu-like symptoms (sweating, chills), most often after the first vaccination, fever> 38 ° C.

Gastrointestinal tract

Often: nausea.

Rare: vomiting.

Very rare: diarrhea.

Muscles and joints

Very common: myalgia.

Often: arthralgia.

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 rarely: allergic reactions (generalized allergic rash, mucosal edema, laryngeal edema, dyspnea, bronchospasm, hypotension) and 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.

Two cases of glioblastoma have been observed in clinical trials.

The frequency of occurrence of this phenomenon in clinical studies was higher than the expected baseline general population frequency described in the literature. However, there was no increase in the incidence of these events during post-marketing surveillance, and a causal relationship with the use of Encepur® Adult has not been established.

There have been 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).

Interaction:

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 with Encepur® adult should be carried out no earlier than 4 weeks later, otherwise the level of specific antibodies may be reduced.

Influence on the ability to drive transport. cf. and fur.:

Studies to study the effect of the Encepur vaccine® adult on the ability to drive vehicles and mechanisms were not carried out (see also the section "Side effects"). Some of the adverse reactions described in the "Side Effects" section may affect the ability to drive vehicles and mechanisms.

Release form / dosage:Suspension for intramuscular injection, 0.5 ml/dose. 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.

Storage conditions:

Store at a temperature of 2 to 8 °C. Do not freeze.

Keep out of the reach of children.

Transportation

By all types of covered transport at a temperature of 2 to 8 °C. Do not freeze.

Shelf life:

24 months.

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

Conditions for dispensing from pharmacies: On prescription Registration number: P N013657/01 Date of registration: 06.03.2009 Cancellation date: 2019-11-08 Instructions

Tick-borne encephalitis vaccine.
Preparation: ENCEPUR FOR CHILDREN
The active substance of the drug: vaccinum encephalitidis ixodicae (inactivatum culturale)
ATX encoding: J07BB02
CFG: A vaccine for the prevention of tick-borne encephalitis
Registration number: P No. 015312/01
Date of registration: 28.11.07
The owner of the reg. Award: NOVARTIS VACCINES AND DIAGNOSTICS GmbH & Co.KG (Germany)

Release form Encepur for children, packaging of the drug and composition.

Suspension for i / m administration is opaque, whitish.

0.25 ml (1 dose)
purified inactivated tick-borne encephalitis virus (strain K 23)
75 mcg

Excipients: aluminum hydroxide (adjuvant), formaldehyde, sucrose, salts, water for injections, trace amounts of antibiotics (neomycin, chlortetracycline and gentamicin).

0.25 ml - glass syringes with needles (1) - blisters.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action Encepur for children

Tick-borne encephalitis vaccine. Titers of antibodies to the tick-borne encephalitis virus are detected in almost all vaccinated (97-98% of those vaccinated) 14 days after the full course of primary immunization.

Vaccination is usually carried out in the cold season before the activity of ticks. If it is necessary to vaccinate during the summer season, it is recommended to use schedule B (emergency vaccination) in order to achieve a protective level of antibodies within 1 month.

Pharmacokinetics of the drug.

Indications for use:

Active prevention of tick-borne encephalitis in children aged 12 months to 11 years.

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

Vaccination is subject to children permanently residing or temporarily residing in territories endemic for tick-borne encephalitis.

Dosage and method of application of the drug.

Primary vaccination course

Primary vaccination is carried out using scheme A. If rapid (emergency) vaccination is required, scheme B is used.
Vaccination
Dose
Scheme A
Scheme B
First vaccination
0.25 ml
0 day
0 day
Second vaccination
0.25 ml
After 1-3 months
On the 7th day
Third vaccination
0.25 ml
9-12 months after the second vaccination
On the 21st day

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

In immunocompromised individuals, antibody levels should be checked between 30 and 60 days after the second schedule A vaccination and the third schedule B vaccination and, if necessary, an additional vaccination should be given.

Revaccination

After a course of primary vaccination, carried out according to one of the two schemes, revaccination is carried out once at a dose of 0.25 ml 1 year after the third vaccination (scheme A), and for those vaccinated according to the rapid (emergency) scheme (scheme B), the first revaccination is carried out after 12 months.

Subsequent remote revaccinations are carried out once every 3 years.

Introduction rules

Shake the syringe well before administering it.

The vaccine is administered intramuscularly, preferably in the deltoid muscle, or in the outer upper quadrant of the gluteal muscle.

If necessary (for example, patients with hemorrhagic diathesis), the vaccine can be administered s / c.

The vaccine must not be administered intravenously.

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

The vaccine should be used immediately after removing the protective sheath from the needle. The vaccination procedure should be carried out with strict observance of the rules of asepsis and antisepsis.

Vaccination is carried out in vaccination rooms run by medical institutions by personnel authorized to carry out vaccinations. The room where vaccination is carried out must be equipped with 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.

Side effects of Encepur for children:

After the introduction of the vaccine in some cases, local and general reactions may develop. In this regard, the vaccinated child must be under medical supervision for 30 minutes after vaccination.

Local reactions: short-term redness, swelling and soreness may appear at the injection site, very rarely in combination with a slight increase in regional lymph nodes.

In isolated cases, a granuloma may develop, in exceptional cases - a seroma (tissue thickening with a vesicle filled with serous fluid). The duration of the reaction is no more than 3-5 days.

General reactions: during the first 2 days (especially after the first vaccination), flu-like symptoms (general malaise, fever over 38 ° C, headache, muscle and joint pain, very rarely nausea, vomit). As a rule, these symptoms disappear within 72 hours and are rarely observed after subsequent vaccinations. Possible vascular reactions (sometimes accompanied by transient nonspecific visual impairment), sweating, chills, fatigue.

Allergic reactions: very rarely - generalized rash, mucosal edema, laryngeal edema, dyspnea, bronchospasm or hypotension, diarrhea.

From the nervous system: in isolated cases, diseases of the central and peripheral nervous system developed, including ascending paralysis (Guillain-Barré syndrome).

Statistics do not indicate an increase in the frequency of primary manifestations or the occurrence of autoimmune diseases (eg, multiple sclerosis) after vaccination. However, in isolated cases, the possibility that vaccination can provoke a disease in patients with a corresponding genetic predisposition cannot be completely excluded. According to current scientific knowledge, vaccination is not the cause of autoimmune diseases.

Contraindications to the drug:

For vaccination

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.

For revaccination (optional)

Severe reactions after previous vaccination (temperature over 40°C, swelling and hyperemia of more than 8 cm in diameter at the injection site).

Special instructions for the use of Encepur for children.

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

In extremely rare cases, when such patients have observed 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.

Persons with a history of the following diseases or conditions should be vaccinated strictly according to the doctor's prescription:

Family history of seizures;

Febrile convulsions (for persons to be vaccinated, it is desirable in this case to prescribe antipyretics immediately before the introduction of the vaccine, as well as 4 hours and 8 hours after vaccination);

Chronic diseases of internal organs, systemic chronic diseases, non-progressive lesions of the central nervous system (post-traumatic);

Eczema and other skin conditions, localized skin lesions;

Congenital or acquired immunodeficiencies;

During treatment with antibiotics or corticosteroids, incl. small doses, as well as topical application of drugs containing steroids.

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

Drug overdose:

Data on overdose of Encepur children's vaccine are not provided.

Interaction of Encepur for children with other drugs.

It is allowed to simultaneously administer the Encepur children's vaccine and other vaccines (except for anti-rabies and BCG) with separate syringes in different parts of the body.

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

After the introduction of immunoglobulin against tick-borne encephalitis, at least 4 weeks are recommended before the introduction of the Encepur children's vaccine, otherwise the level of specific antibodies may be reduced.

Conditions of sale in pharmacies.

The drug is dispensed by prescription.

Terms of the storage conditions of the drug Encepur for children.

The vaccine should be stored and transported at temperatures between 2° and 8°C; do not freeze. Do not use vaccine after freezing.

Keep out of the reach of children.

Shelf life - 24 months. Do not use after the expiry date stated on the packaging.

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

Registration number:

P N013657/01-060309

Dosage form:

Suspension for intramuscular injection 0.5 ml/dose

Compound:

one dose (0.5 ml) of the vaccine contains:
Active ingredients: antigen of tick-borne encephalitis virus (strain K23) propagated on a cell culture of a chicken embryo, inactivated, purified, 1.5 μg
Auxiliary components: Trishydroxymethylaminomethane 2.55 mg, Sodium chloride 2.4 mg, Sucrose 20-30 mg, Aluminum hydroxide 1 mg, Water for injection up to 0.5 ml.
The vaccine does not contain preservatives.

Description: Opaque suspension of whitish color without extraneous inclusions.

Pharmacotherapeutic group:

inactivated vaccine

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;

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.

Method of application and dosage:
a) 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. on the 21st day. After completion of vaccination, the protective antibody titer is maintained for 12-18 months, after which it is recommended to revaccinate.
In immunocompromised individuals and individuals 59 years of age and older, antibody levels should be checked between 30 and 60 days after the second schedule A vaccination and the third schedule B vaccination and, if necessary, an additional vaccination should be given.
b) Revaccination.
After a course of primary vaccination according to one of the two schemes, one injection of 0.5 ml of Encepur adult is sufficient to maintain a strong immune system. Based on the results of clinical studies performed, the following intervals for revaccination 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 vaccinated under the emergency schedule (Scheme B), the following intervals are recommended. Method of administration:
Shake the syringe well before administering the vaccine!
The vaccine is administered intramuscularly, preferably in the region of the upper third of the shoulder (deltoid muscle). If necessary (for example, in patients with hemorrhagic diathesis), the vaccine can be administered subcutaneously.
Do not administer intravenously!
Incorrect intravenous administration of the vaccine can cause allergic reactions up to shock. 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 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 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 individuals 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 of internal organs, systemic diseases,

vaccination can be carried out simultaneously with the appointment of drug treatment appropriate to this disease.

Interaction with other drugs:
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!

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

Holiday conditions. Released by prescription.

Manufacturer:

Novartis Vaccines and Diagnostics GmbH & Co. KG., Emil-von-Behring-Str. 76, D-35041 Marburg, Germany. Novartis Vaccine and Diagnostics GmbH & Co. KG., Germany, Emil von Behring Str. 76, D-35041 Marburg, Germany Information about all cases of complications after vaccination should be sent to the MIBP National Control Authority - FSUE GISK im. L.A. Tarasevich Rospotrebnadzor, 119002 Moscow, Sivtsev Vrazhek, 41 and to the representative office of the manufacturer: Novartis Vaccines and Diagnostics GmbH and Co. KG”, Germany 119002 Moscow, Glazovsky lane, 7, office 9.

Last 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

pharmachologic effect- immunostimulating.

Dosage and administration

V / m, 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 PC.

You cannot enter I/O.

Incorrect intravenous administration of the vaccine can cause allergic reactions up to shock. 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.

Shake the syringe well before administering the vaccine.

Primary vaccination course

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

Table 1

Vaccination			Scheme A
1st vaccination	0,25	0,5	0th day
2nd vaccination	0,25	0,5	after 1-3 months
3rd vaccination	0,25	0,5	9-12 months after the 2nd vaccination

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

The traditional scheme is preferred for individuals in endemic areas.

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

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

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

table 2

Vaccination	Dose for children from 1 to 11 years, ml	Dose for adults and children from 12 years old, ml	Scheme B
1st vaccination	0,25	0,5	0th day
2nd vaccination	0,25	0,5	in 7 days
3rd vaccination	0,25	0,5	in 21 days

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 is maintained for 12-18 months, after which it is recommended to revaccinate.

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

Revaccination

After a course of primary vaccination, carried out according to one of the two schemes, one injection is sufficient to maintain a tense immunity. Based on the results of clinical trials, the booster intervals shown in Tables 3, 4 should be used.

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

Table 3

For individuals vaccinated under the emergency schedule (Scheme B), the following intervals are recommended.

Registration certificate holder:
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:

You should consult with your doctor before using ENCEPUR CHILDREN. These instructions for use are for informational purposes only. For more information, please refer to the manufacturer's annotation.

Clinical and pharmacological group

Release form, composition and packaging

Suspension for i / m introduction of a whitish color, 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 in chick embryo cell culture, inactivated, purified.

pharmachologic effect

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

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

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

Introduction rules

Shake the vaccine well immediately before administration.

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

If necessary (for example, patients with hemorrhagic diathesis), the vaccine can be administered s / c.

The vaccine must not be administered intravenously.

Incorrect intravenous administration of the vaccine can cause reactions up to shock. 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.

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
after 12-18 months
every 5 years

Overdose

Data on overdose of Encepur® children's vaccine are not provided.

drug interaction

Simultaneous injection of Encepur® children's 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 immunoglobulin against tick-borne encephalitis, vaccination with Encepur® 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 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 -

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 at the injection site: very often - transient pain at the injection site; 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.

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

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

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

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

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

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

Terms and conditions of storage

The vaccine should be stored and transported at temperatures between 2° and 8°C; do not freeze. Keep out of the reach of children. Expiration date - 24 months. Do not use after the expiry 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 use of the vaccine for adults is indicated.

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 epidemic season of tick-borne encephalitis.

Contraindications

• acute febrile conditions of any etiology or exacerbation of chronic infectious diseases.
• Vaccination is not carried out before
• than 2 weeks after the disappearance of 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.

special instructions

In general, there is no increased risk when immunized with Encepur® Children's Vaccine in children with allergic reactions to chicken protein or a positive skin reaction to ovalbumin.

In extremely rare cases, when such patients have observed 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 of persons with a history of brain lesions should be carried out after the conclusion of a neuropathologist.

Persons with a history of the following diseases or conditions should be vaccinated strictly according to the doctor's prescription:

• common infection,
• especially if there is an increase in body temperature over 38 ° C;
• family history of seizures;
• febrile convulsions (persons
• subject to vaccination, it is desirable in this case to prescribe antipyretics immediately before the introduction of the vaccine,
• and also 4 hours and 8 hours after vaccination);
• eczema and other skin diseases,
• localized skin infections;
• during treatment with antibiotics or corticosteroids,
• including
• in small doses
• as well as topical application of drugs,
• containing steroids;
• non-progressive lesions of the central nervous system;
• congenital or acquired immunodeficiencies;
• chronic diseases of internal organs,
• systemic chronic diseases.

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

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Registration numbers

susp. d / i / m injections 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…