Composition, form of production and packaging
Suspension for i / m administration 1 dose (0.5 ml)
hemagglutinin and influenza A neuraminidase (strain H1N1) 15 Ојg
1 dose - ampoules (10) - packs of cardboard.
1 dose - ampoules (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
PHARMACHOLOGIC EFFECT
The vaccine is surface glycoproteins (hemagglutinin and neuraminidase) isolated from purified influenza viruses of type A / California / 7/2009 (H 1 N 1 ) v, grown on chick embryos, sorbed on aluminum hydroxide.
The vaccine causes the formation of specific immunity in humans against influenza A / H 1 N 1 /.
INDICATIONS
- specific prevention of influenza A / H 1 N 1 / in people aged 18-60 years.
DOSING MODE
The vaccine is injected once / in the upper third of the outer surface of the shoulder (in the deltoid muscle region) at a dose of 0.5 ml. Before administration, the ampoule with the preparation should be shaken until a homogeneous suspension is obtained.
The drug is not suitable for use in ampoules with broken integrity or marking, with expired shelf life, improper storage.
Opening of ampoules and the vaccination procedure are carried out with strict adherence to the rules of aseptic and antiseptic. The drug in the opened ampoule is not subject to storage.
Vaccination is recorded in the prescribed registration forms with the date of administration of the drug, dose, serial number and name of the manufacturer.
SIDE EFFECT
In the place of administration of the vaccine there may be reactions in the form of pain, redness and swelling of the skin. Individuals may have general reactions in the form of increased fatigue, headache, dizziness, subfebrile temperature, rhinitis, 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 influenza vaccines;
- acute infectious and non-infectious diseases, chronic diseases in the acute stage - vaccination is carried out not earlier than a month after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after normalizing the temperature;
- vaccination with rabies vaccines less than 2 months before immunization;
- systemic connective tissue diseases;
- adrenal gland diseases;
- hereditary, degenerative and progredient diseases of the nervous system;
- Pregnancy;
- lactation;
- Hypersensitivity to chicken protein.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
In acute infectious and non-infectious diseases, chronic diseases in the acute stage - vaccination is carried out not earlier than a month after recovery (remission).
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
In acute infectious and non-infectious diseases, chronic diseases in the acute stage - vaccination is carried out not earlier than a month after recovery (remission).
SPECIAL INSTRUCTIONS
All persons subject to vaccination should be examined by a doctor in the light of anamnestic data.
On the day of immunization, the vaccinated should be examined by a physician with mandatory thermometry. At a body temperature of 37 В° C or higher, there is no vaccination. The doctor is responsible for the correct administration of the vaccine.
The possibility of vaccination of persons suffering from chronic diseases not listed in the list of contraindications is determined by the attending physician based on the patient's condition.
Precautionary measures
Do not enter iv. 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 (determined by the attending physician). 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
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
The preparation is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 В° to 8 В° C in a place inaccessible to children. Freezing is not allowed. Shelf life - 1 year. After the expiration date, the drug is not applicable.
