Composition, form of production and packaging
Solution for the / m introduction 0.5 ml (1 dose)
hemagglutinin and neuraminidase of the following viral strains:
A (H 3 N 2 ) * 15 Ојg GA **
A (H 1 N 1 ) * 15 Ојg GA **
B * 15 Ојg GA **
* - after the name of the strain, the name of the type is issued; the strain composition is aligned with WHO recommendations for the current influenza epidemic season.
** - hemagglutinin.
0.5 ml - ampoules (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The influenza inactivated split vaccine is a mixture of highly purified protective surface and internal antigens of influenza A (H 1 N 1 and H 3 N 2 ) and type B viruses.
The vaccine is well tolerated by adults, forms high specific immunity against influenza type A and B. After immunization, immunity persists for up to 12 months.High efficiency of the vaccine is ensured by the presence in it of both surface and internal antigens of the influenza virus.
INDICATIONS
- Specific prevention of influenza in humans.
Annual vaccination is recommended for people with a high risk of complications and people who are at a high risk of influenza or who are infected by other people:
- persons suffering from chronic physical illnesses;
- often ill acute respiratory infections;
- medical workers;
- employees in the service sector;
- transport workers;
- employees of educational institutions.
Allowed use from age 12 without age limitation.
DOSING MODE
Vaccination is carried out annually in the autumn-winter period. It is possible to vaccinate at the beginning of an epidemic rise in the incidence of influenza.
The vaccine is given in / m in the upper third of the outer surface of the shoulder (in the deltoid muscle).
Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules: before opening the ampoule, the neck of the ampoule is wiped with cotton wool soaked with 70% ethyl alcohol, the ampoule is opened, the vaccine is taken into a disposable syringe and excess air is removed from the syringe. Alcohol rubs the skin at the injection site. The drug in the opened ampoule is not subject to storage.
On the day of vaccination, the vaccinated should be examined by a physician (paramedic) with obligatory thermometry. At a temperature above 37 В° C vaccination is not carried out.
The preparation is not suitable for use in ampoules with broken integrity or marking, with changing physical properties (color, transparency), expired shelf life, violation of storage requirements.
SIDE EFFECT
Local and general reactions to the introduction of the vaccine are largely absent. Rarely at the injection site, there may be reactions in the form of soreness, redness and swelling of the skin. Individuals may have general reactions in the form of increased fatigue, headache, dizziness, subfebrile temperature, runny nose, pharyngitis, coughing, arthralgia, myalgia, nausea. These reactions usually disappear on their own in 1-3 days. In extremely rare cases with high individual sensitivity, allergic reactions can be observed.
CONTRAINDICATIONS
- allergic reactions to previous vaccinations, chicken protein and vaccine components;
- acute feverish conditions or exacerbation of a chronic disease.
For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after normalizing the temperature.
Vaccinations are carried out after recovery (remission).
PREGNANCY AND LACTATION
Clinical studies have not been conducted.
APPLICATION FOR CHILDREN
Allowed use from age 12 without age limitation.
SPECIAL INSTRUCTIONS
Do not administer intravenously. In the offices where the vaccination is carried out, it is necessary to have medicines for carrying out anti-shock measures and stopping the anaphylactic reaction.
The vaccinated should be monitored by a health worker within 30 minutes after immunization.
DRUG INTERACTION
The vaccine can be administered against the background of basic therapy of the underlying disease. The vaccine can be used concomitantly with other inactivated vaccines. This should take into account contraindications to each of the vaccines used, the drugs must be injected into different parts of the body with different syringes.
TERMS OF RELEASE FROM PHARMACY
Released by prescription
TERMS AND CONDITIONS OF STORAGE
Storage and transportation in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 В° C in a place inaccessible to children. Freezing is not allowed. Keep out of the reach of children.
