EnceVir Neo for children, 0.25 ml/dose 0.25 ml 10 pcs

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

The preventive vaccination is subject to:

– persons living in tick-borne encephalitis endemic areas;
– persons visiting tick-borne encephalitis endemic areas for recreation, tourism, work in dacha and garden plots.

Active ingredient

Composition

Active ingredient:

from 0.3 to 1.5 µg of inactivated tick-borne encephalitis virus (BE) antigen.

Auxiliary substances:

Aluminum hydroxide (adjuvant),

saccharose (stabilizer),

Human albumin (stabilizer)*,

Buffer system salts**:

sodium chloride,

sodium hydrophosphate dodecahydrate,

sodium dihydrophosphate dihydrate.

The vaccine contains no antibiotics or preservatives.

How to take, the dosage

The vaccine is injected into the deltoid muscle of the arm (preferably the left arm) in a dose of 0.25 ml. In young children, the vaccine can be injected into the upper external surface of the middle thigh. Before opening the ampoule it is necessary to make a visual inspection.

Immediately before injection the vaccine in the ampoule is warmed to room temperature and shaken to a homogeneous suspension. The neck of the ampoule is treated with alcohol. A separate disposable syringe must be used for each vaccinated person. The drug is injected immediately after opening the ampoule. The vaccination procedure must be carried out in strict compliance with the rules of asepsis and antiseptics.

The vaccination is recorded in the established record forms with the name of the drug, date of vaccination, dose, series number, expiration date, the manufacturer of the vaccine, the reaction of the vaccinated person to the vaccination.

Vaccination schedules. Scheduled vaccination. The vaccination course consists of two injections in 1 dose (0.25 ml) with 1-7 month intervals (preferably 2 months).

The first and second injections are preferably administered in the period from fall to spring. If necessary, vaccination can be carried out at any time of the year, including the summer period (epidemic season). A visit to a natural center of KE is allowed no earlier than 2 weeks after the second vaccination.

Emergency vaccination. In case of emergency prophylaxis (especially in summer time) the interval between the first and second vaccinations can be shortened to 2 weeks. It is recommended to visit a natural center of CS no earlier than 2 weeks after the second vaccination.

Revaccination. The first revaccination for both regimens is carried out once 12 months after completion of the primary vaccination course, subsequent remote revaccinations are carried out once every 3 years.

Contraindications

A history of hypersensitivity to chicken embryo protein is not an absolute contraindication, except for anaphylaxis. However, these people should be vaccinated with caution.

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

Pregnancy and breastfeeding. The use of the vaccine during pregnancy is contraindicated. Vaccination of women during the breast-feeding period is carried out by a doctor’s decision with taking into account the risk of getting QE.

Side effects

According to the data obtained during clinical studies, after vaccine administration local and general reactions are possible, which occurred mainly at the first injection of the vaccine and passed on their own without the administration of specific therapy within a few hours to a few days (2 – 4 days).

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

General reactions develop in the form of malaise, drowsiness, increased fatigue, headache, dizziness, nausea, abdominal pain, myalgia, increased body temperature up to 38.5 ºC.

Allergic reactions may develop.

In case the patient has poor tolerance of fever (up to 38.5 ºC) symptomatic therapy is administered.

The following information about the frequency of adverse reactions was obtained based on data from the clinical study of the vaccine:

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

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

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

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

Very rare (< 1/10,000) – pronounced neurological symptomatology.
Permissible frequency for general reactions with temperature over 37.5 ºC – no more than 4%.