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Dosage form: & nbsp
Lyophilizate for the preparation of a solution for intranasal administration.

Composition:

In one vaccination dose of 0.5 ml contains:

- vaccine strain of the avian influenza virus type A, obtained from the virus-containing allantoic liquid of chick embryos - not less than 107,0 EID5o / dose;

- stabilizer M-2 - 30.6 mg;

- solvent - water for injection.

The strains of the vaccine are modified in accordance with the recommendations of the WHO and / or the Commission on influenza and diagnostic strains.

Description:

The preparation is an amorphous white mass.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp
  • Vaccine for the prevention of influenza
  • Pharmacodynamics:

    Immunological properties

    The vaccine causes the formation of specific immunity in humans against avian influenza A. The protective effect of the vaccine, as a rule, occurs 21 days after the second vaccination.

    Indications:

    Specific prevention of avian influenza in humans.

    Contingents subject to vaccination

    Vaccination is recommended for people aged 18 to 60 due to epidemiological indications.
    Contraindications:

    1. Acute infectious and non-infectious diseases are temporary contraindications for vaccination. Vaccination is carried out 2-4 weeks after recovery.For non-severe acute respiratory viral infections, acute intestinal diseases, etc., inoculation is carried out after normalizing the temperature.
    2. Chronic diseases in the stage of exacerbation or decompensation. Hypersensitivity to chicken protein. Reaction or post-vaccination complication of previous administration of seasonal influenza vaccines.
    3. Immunodeficiency state (primary), immunosuppression, malignant neoplasms.
    4. Diseases of the nasopharynx in the acute stage.
    5. Pregnancy and lactation.

    All persons subject to vaccinations should be examined by a physician (paramedic), taking into account anamnestic data. On the day of vaccination, the vaccinated should be examined by a physician (paramedic) with obligatory thermometry. At a temperature above 37 ° C vaccinations are not carried out. The doctor (paramedic) is responsible for the correct appointment of the vaccine. The vaccine is recorded in the prescribed registration forms with the date, the manufacturer of the drug, the serial number, the reaction to the vaccination.

    Pregnancy and lactation:Clinical studies were not conducted
    Dosing and Administration:

    The vaccine is administered intranasally 2 times at intervals of 10 days by means of a dispenser - dispenser (PD).

    Immediately before vaccination, the contents of the ampoule are dissolved at room temperature in 0.5 ml of the solvent included in the vaccine kit.

    The vaccine should be completely dissolved within 3 minutes. Dissolved drug - colorless, slightly opalescent liquid.

    It is not suitable to use the drug in ampoules with broken integrity, marking, as well as changing its physical properties (color, transparency), with improper storage.


    The vaccine is injected into the nasal passages at a rate of 0.25 ml per each nasal opening.

    To administer the vaccine in the form of a finely divided mixture, a sterile syringe, a sterile needle and one removable nozzle Actuators-183.016 single-use, included in the vaccine kit.

    The spray tip is injected to a depth of 0.5 cm into the nasal passages, previously cleaned of mucus. The grafted should be in a sitting position with a slightly upturned head. After vaccine administration, the vaccine should remain in a sitting position with a slightly upturned head for 1 minute. Dissolved vaccine should be used within 30 minutes.

    Method of use for vaccination:

    1. Put the needle on the syringe, fill it with a solvent (water for injections) of room temperature, included in the vaccine kit, in a volume of 0.5 ml.

    2. To dissolve, fill the opened ampoule with the vaccine with a solvent from the syringe.

    3. After dissolving, fill the syringe with the preparation in a volume of 0.5 ml (mark 20 on a scale of 80 units or a mark of 50 on a scale of 100 units).

    4. Remove the needle and put on a tightly detachable nozzle Acuators-183.016 (spray tip).

    5. Bring the nozzle tip close to the nasal passage and squeeze the vaccine into each nasal passage of 0.25 ml with sharp pressure on the syringe plunger.




    Precautionary measures

    The grafted should be in a sitting position with a slightly upturned head. After vaccine administration, the vaccine should remain in a sitting position with a slightly upturned head for 1 minute. Dissolved vaccine should be used within 30 minutes.

    Side effects:

    After vaccination for 4 days. some vaccinated people may have: an increase in temperature to 37.5 ° C, malaise, headache, minor catarrhal phenomena. The presence of reactions with an increase in temperature above 37.5 ° C is not more than 2% of the vaccinated. The duration of the temperature reaction should not exceed 3 days.

    Interaction:

    Not installed.

    Form release / dosage:

    Lyophilizate for the preparation of a solution for intranasal administration.

    Packaging:1 dose of vaccine lyophilizate for the preparation of solution for intranasal administration complete with a solvent in ampoules. Produced included: 1 vial of vaccine (1 dose), 1 vial of solvent (1.0 ml), the syringe 1 with the needle in a contour bezgyachakova packaging removable nasadkaActuators 1-183.016 and instructions for use in a stack of cardboard boxed.
    Storage conditions:

    Storage and transportation conditions

    Do not use the drug after the expiry date of the drug is not applicable. The vaccine was stored and transported in accordance with JV 3.3.2.1248-03 at a temperature of from 2 ° C to 8 ° C in a dry and reach of children. Freezing is not allowed. Transportation at a temperature of 9 ° C to 25 ° C with a duration of not more than 10 days is allowed.

    Shelf life: 2 years.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002340/09
    Date of registration:25.03.2009/04.10.2013
    The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.06.2016
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