Encepur children - instructions for use, dose, side effects, contraindications

active components : the antigen of the tick-borne encephalitis virus (strain K23) of the chicken embryo reproduced on culture, inactivated, purified 0.75 μg;

auxiliary components: tris-hydroxymethylaminomethane 1.28 mg, sodium chloride 1.2 mg, sucrose 10-15 mg, aluminum hydroxide 0.5 mg, water for injection up to 0.250 ml.

The vaccine does not contain preservatives.

Description:

Opaque suspension whitish color without foreign inclusions.

Pharmacotherapeutic group:MIBP vaccine

ATX: & nbsp

J.07.B.A Vaccine for the prevention of encephalitis

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

Pharmacodynamics:

Immunobiological properties:

Titers of antibodies to the TB virus are detected in all those vaccinated after a full course of primary immunization.

For immunization according to scheme A:

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

2 weeks after the second inoculation (day 42): 98% of the vaccinated;

2 weeks after the 3rd vaccination (314 days): 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): 90% of the vaccinated;

After the third vaccination (day 35): 99% of the vaccinated.

Indications:

Active prophylaxis of tick-borne encephalitis (TBE) for children aged 1 to 11 years inclusive. For children from 12 years of age, a vaccine is used for immunization of adults.

Vaccination is indicated for persons permanently residing or temporarily residing in territories endemic for tick-borne encephalitis.

Vaccination can be carried out all the year round, including the period of the epidemic season.

Contraindications:

1. Acute feverish conditions of any etiology or exacerbation of chronic infectious diseases Vaccinations are conducted no earlier than 2 weeks after the disappearance of signs of acute disease (normalization of body temperature);

2. Presence of allergy to vaccine components.

If the complication arose after the 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 with regard to adverse reactions that are not limited to the injection site.

Carefully:

As a rule, there is no increased risk when vaccinating Encepur® in children who are considered to be "allergic to chicken protein" or who have a positive skin reaction to ovalbumin.

In those extremely rare cases where such patients have had clinical symptoms such as a rash, swelling of the lips and / or epiglottis, lagging or bronchospasm, hypotension or shock,The vaccine should be administered only with careful clinical observation in a room provided with anti-shock therapy.

The need for vaccination of people with cerebral lesions in history should be carried out after the conclusion of a neurologist.

Persons with the following diseases:

- a common infection, especially if there is a temperature increase of more than 38 ° C;

- seizure in a family history;

- febrile convulsions (persons who are to be vaccinated, it is desirable in this case to prescribe antipyretics immediately before the introduction of the vaccine, and also 4 and 8 hours after vaccination);

- eczema and other skin diseases, localized skin infection;

- treatment with antibiotics or low doses of corticosteroids or topical application of preparations containing steroids;

- non-progressive lesions of the central nervous system;

- congenital or acquired immunodeficiencies;

- chronic diseases of internal organs, systemic diseases -

Vaccination is strictly according to the doctor's prescription. If necessary, these persons can be prescribed treatment corresponding to the underlying disease.

Dosing and Administration:

a) The primary course of vaccination.

Primary vaccination is performed using scheme A (the traditional scheme).

Vaccination	Dose	Scheme A
First Inoculation	0.25 ml	0 day
Second Inoculation	0.25 ml	After 1 -3 months.
Third Inoculation	0.25 ml	9-12 months after the second vaccination

The second dose can be administered 14 days after the first dose

A traditional scheme is preferable for people in endemic areas.

Seroconversion develops no earlier than 14 days after the second vaccination

After the vaccination is completed, the protective titer of the antibodies persists for at least 3 years, after which it is recommended to conduct a booster.

If rapid (emergency) vaccination is required, scheme B:

Vaccination	Dose	Scheme B
First Inoculation	0.25 ml	0 day
Second Inoculation	0.25 ml	In 7 days
Third Inoculation	0.25 ml	After 21 days

Seroconversion develops no earlier than 14 days after the second inoculation, ie on the 21st day. After the vaccination is completed, the protective antibody titer persists for 12-18 months, after which it is recommended to revaccinate

Children with immunodeficiency should check the level of antibodies in the period from 30 to 60 days after the second vaccination according to scheme A and the third vaccination according to scheme B and, if necessary, an additional vaccination

b) Revaccination.

After a course of primary vaccination, performed according to one of the two schemes, one injection of Enzepur® children's 0.25 ml is sufficient to obtain intense immunity. For children from the age of 12, the Encepur adult vaccine should be used.

Based on the results of clinical trials conducted, the following intervals should be used for booster vaccination.

For children who received vaccination according to the traditional scheme (Scheme A), the following intervals are recommended:

The first dose for revaccination	All subsequent booster revaccinations
3 years	Every 5 years

For children who received an emergency vaccine (Scheme B), the following intervals are recommended.

The first dose for revaccination	All subsequent booster revaccinations
In 12-18 months	Every 5 years

Method of administration:

Immediately before administration, the vaccine should be shaken well!

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

Do not administer intravenously!

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

On the day of vaccination, the doctor (or paramedic) conducts a survey and examines the vaccine with mandatory thermometry, examines the medical card of the vaccinated person. The doctor is responsible for the correct administration of the vaccine.

The vaccination is recorded in the prescribed registration forms with the date of vaccination, dose, name of vaccine, manufacturer, serial number, expiration date, response to vaccination.

Only a full course of vaccination provides reliable protection.

Side effects:

In assessing the side effects of the drug, the following frequency data was the basis:

Very often - ≥10%

Often - from 1 to 10%

Occasionally, from 0.1 to 1%

Rarely, from 0.01 to 0.1%

Very rarely - <0.01%, including isolated cases

Based on the data obtained during clinical trials and the results of clinical use of the vaccine, the following information was obtained on the incidence of side effects:

Local reactions in the field of injection

Very often: transient pain at the injection site.

Often: redness, swelling.

Very rarely: granuloma at the site of injection,in the form of an exception with the formation of a tumor-like accumulation of serum in the tissues

Systemic reactions

Very often: in children from one year to two years - 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 3 to 11 years old).

Gastrointestinal tract

Often: nausea.

Rarely: vomiting, diarrhea.

Muscles and Joints

Often: arthralgia and myalgia.

Very rarely: arthralgia and myalgia in the occiput.

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

Circulatory and lymphatic system

Very rarely: lymphadenopathy (lymph node involvement / enlargement).

Nervous system

Very often: drowsiness in children younger than three years.

Often: headaches in children older than three years.

Very rarely: malaise (eg, itching, numbness of the limbs), convulsions with fever.

The immune system

Very rarely: allergic reactions (eg, generalized allergic rash, mucosal edema, laryngeal edema, dyspnoea, bronchospasm, hypotension and other reactions with possible temporary nonspecific visual impairment, short-term thrombocytopenia).

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

There were reports that, in isolated cases after vaccination against CE, there were diseases of the central and peripheral nervous system, including ascending paralysis (Guillain-Barre syndrome).

Interaction:

Simultaneous vaccination of Encepur® children is possible and the introduction of other vaccines with separate syringes to different parts of the body

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

After the introduction of immunoglobulin against tick-borne encephalitis, Enzenur® should be given to children not earlier than 4 weeks later, otherwise the level of specific antibodies can be reduced.

Form release / dosage:A suspension for intramuscular administration, 0.25 ml / dose.

Packaging:

For 0.25 ml (1 dose) in a sterile disposable syringe made of hydrolytic class I glass (Hebrew Pharm.) With a needle covered with a rubber cap. A label with a marking is affixed to the syringe on which the arrow indicates the separable part of the label intended for registrationvaccination in a medical record. One syringe with a needle in a blister (PVC). One blister with instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Transportation

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

Shelf life:

24 months.

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

Terms of leave from pharmacies:On prescription

Registration number:П N015312 / 01

Date of registration:02.04.2009

The owner of the registration certificate:Novartis Vaccines & Diagnostics Sr.L. Novartis Vaccines & Diagnostics Sr.L. Italy

Manufacturer: & nbsp

NOVARTIS VACCINES AND DIAGNOSTICS, S.r.l. Italy

Representation: & nbspNOVARTIS PHARMA LLCNOVARTIS PHARMA LLC

Information update date: & nbsp14.12.2015

Illustrated instructions

Instructions

Encepur® for children (Encepur® baby)