EnceVir Neo for children,suspension 0.25mg/dose ampoule 10pcs

Composition

Active ingredient:

0.3 to 1.5 micrograms of inactivated tick-borne encephalitis virus (CE) antigen.

Auxiliary substances:

aluminum hydroxide (adjuvant),

sucrose (stabilizer),

human albumin (stabilizer)*,

buffer system salts**:

sodium chloride,

sodium hydrophosphate dodecahydrate,

sodium dihydrogen phosphate dihydrate.

The vaccine does not contain any antibiotics or preservatives.

Indications

Specific prevention of tick-borne encephalitis in children from 3 to 17 years (inclusive).

Preventive vaccination is subject to:

• people who live in tick-borne encephalitis-endemic territories; • people who visit tick-borne encephalitis-endemic territories for recreation, tourism, and work in suburban and garden areas.

Contraindications

Hypersensitivity to chicken embryo protein in the anamnesis is not an absolute contraindication, excluding anaphylaxis. However, such individuals should be vaccinated with caution.

The vaccine is used with caution in people with a history of cerebral disorders.

Use during pregnancy and lactation. The use of the vaccine during pregnancy is contraindicated. Vaccination of women during breastfeeding is carried out by a doctor’s decision, taking into account the risk of infection with TBE.

Side effects

According to data obtained during clinical studies, local and general reactions may develop after the introduction of the vaccine, which occurred mainly on the first use of the vaccine and passed independently without prescribing specific therapy in the period from several hours to several days (2-4 days).

Local reactions are expressed in redness, swelling, soreness at the injection site.

General reactions develop in the form of malaise, drowsiness, increased fatigue, headache, dizziness, nausea, abdominal pain, myalgia, and an increase in body temperature up to 38.5 ° C. Allergic reactions may occur.

If the patient has poor tolerance to elevated temperature (up to 38.5 ° C), symptomatic therapy is performed.

Based on the data obtained as a result of a clinical study of the vaccine, the following information was obtained on the frequency of adverse reactions:

Very common (≥1/10) – soreness at the injection site.

Often – 1/10-1/100) – hyperemia at the injection site, swelling at the injection site, fever up to 38.5 ° C (especially for the first vaccination), passing within 1 to 4 days, headache, weakness, malaise, fatigue, drowsiness, abdominal pain, myalgia.

Sometimes (1/100 – 1/1000) – nausea, dizziness.

Rarely (1/1000 – 1/10000) – allergic reactions of immediate and delayed types.

Very rare ( The permissible frequency for general reactions with temperatures above 37.5 ° C is not more than 4%.

How to take, course of use and dosage

The vaccine is injected into the deltoid muscle of the arm (preferably the left one) in a dose of 0.25 ml. In young children, the vaccine can be injected into the upper outer surface of the middle thigh. Before opening the ampoule, it is necessary to perform its visual inspection. Immediately before injection, the vaccine in the ampoule is warmed to room temperature and shaken until a homogeneous suspension is obtained. The neck of the ampoule is treated with alcohol. A separate disposable syringe should be used for each vaccinated person. The drug is administered immediately after opening the ampoule. The vaccination procedure should be carried out in strict compliance with the rules of asepsis and antiseptics. The vaccination carried out is registered in the established accounting forms with the indication of the name of the drug, the date of vaccination, dose, batch number, expiration date, the manufacturer of the vaccine, the reaction of the vaccinated person to vaccination. Vaccination schemes. Routine vaccination. The course of vaccination consists of two injections of 1 dose (0.25 ml) with an interval of 1-7 months (preferably 2 months). The first and second injections are preferably carried out in the period from autumn to spring. If necessary, vaccination can be carried out at any time of the year, including in the summer (epidemic season). A visit to the natural focus of CE is allowed no earlier than 2 weeks after the second vaccination. Emergency vaccination. If emergency prevention is necessary (first of all, if vaccination is necessary in the summer), the interval between the first and second vaccinations can be reduced to 2 weeks. A visit to the natural focus of CE is recommended no earlier than 2 weeks after the second vaccination. Revaccination. The first revaccination with both schemes is carried out once 12 months after the completion of the primary vaccination course, and subsequent long-term revaccinations are carried out once every 3 years.

Storage conditions

The vaccine should be stored at a temperature of 2° to 8°C; do not freeze

Shelf

life is 2 years.

Active ingredient

Vaccine for the prevention of tick-borne encephalitis

Conditions of release from pharmacies

By prescription

Dosage form

suspension for injection