Active substanceVaccine for the prevention of influenza [live]Vaccine for the prevention of influenza [live]
Dosage form: & nbsplyophilizate for the preparation of a solution for intranasal administration
Composition:

. In one dose of the vaccine (0.5 ml) contains:

- Vaccine strain of the influenza virus type A / 17 / California / 2009/38 (H1N1), obtained from the virus-containing allantoic fluid of chick embryos - not less than 107,0 EID50;

- stabilizer M-2: sucrose, lactose, glycine, sodium glutamate, tris (hydroxymethyl) -aminomethane, sodium chloride, gelatin.

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:

Amorphous mass of white color.

Pharmacotherapeutic group:MIBP vaccine
ATX: & nbsp

J.07.B.B   Vaccine for the prevention of influenza

J.07.B   Vaccines for the prevention of viral infections

Pharmacodynamics:

Immunological properties.

The vaccine causes the formation of specific immunity in humans against influenza type A/H1N1/.

Indications:

Specific prevention of influenza type A/H1N1/ in people in age from 18 to 60 years.

Contraindications:

- 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.

- 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.

- Immunodeficiency status (primary), immunosuppression, malignant neoplasms.

- Diseases of the nasopharynx in the acute stage.

- 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 Inoculation is registered in the established registration forms with the indication of the date,enterprise-manufacturer of the drug, serial number, response to vaccination.

Dosing and Administration:

The vaccine is administered intranasally, twice with an interval of 10 days. Immediately before vaccination, the contents of the ampoule are dissolved at room temperature in an appropriate volume of solvent (0.5 ml, 1.0 ml, 15 ml or 3.0 ml for the vaccine at 1, 2, 3 doses or 6 doses, respectively). The vaccine should be completely dissolved within 3 minutes.

Dissolved drug - a clear or slightly opalescent liquid. Dissolved vaccine should be used within 30 minutes.

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 dispersed mixture, a dispenser is used - a dispenser consisting of a sterile syringe, a sterile needle and one disposable disposable nozzle included in the vaccine kit.

Spray dispenser (removable nozzle) is injected at a depth of 0.5 cm into the nasal passages, previously cleaned of mucus. The grafted should be sitting in a sitting position with a slightly upturned head.After vaccine administration, the vaccine should remain in this position for 1 min.

Mode of application:

1. Put the needle on the syringe, fill it with a solvent (water purified or water boiled room temperature).

2. Add the solvent (0.5, 1.0, 1.5 or 3.0 ml according to the vaccine form) to the opened ampoule with the vaccine from the syringe.

3. After dissolving, fill the syringe with the drug in a volume of 0.25 ml (a mark of 10 on a scale of 40 units or a mark of 25 on a scale of 100 units).

4. Remove the needle and put on a tightly detachable nozzle.

5. Bring the nebulizer dispenser close to the nasal passage and squeeze the vaccine into the nasal passage with a sharp push on the syringe plunger.

6. Remove the dispenser dispenser, put on the needle and fill the syringe with the next dose of the drug (0.25 ml).

7. Remove the needle, re-tighten the same dispenser and inject the drug into the other nasal passage in accordance with paragraph 5.

For the subsequent vaccinations (the form of release more than 1 dose in an ampoule), repeat the actions described in p. 3-7, with the mandatory replacement of the removable attachment for each subsequent vaccine.

Precautionary measures. The graft is recommended to be isolated within 3 days from children of the first half of life and from individuals with a primary and severe secondary immunodeficiency state.

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 grafted. The duration of the temperature reaction should not exceed 3 days.

Interaction:

It is not recommended after the vaccination to use within 2 days of any drugs administered intranasally.

Form release / dosage:

Liofilizate for the preparation of solution for intranasal administration 0.5000 ml / dose.

Packaging:In ampoules of 1, 2, 3, 6 doses. Available in sets:

1) 1 ampoule with a vaccine (1 dose), 1 syringe with a needle, 1 removable nozzle-sprayer and instructions for use in a pack of cardboard box.

2) 1 ampoule with a vaccine (2 doses), 1 syringe with a needle, 2 removable nozzles-sprayers and instructions for use in a pack of cardboard box.

3) 1 ampoule with a vaccine (3 doses), 1 syringe with a needle, 3 removable nozzles-sprayers and instructions for use in a pack of cardboard box.

4) 1 ampoule with a vaccine (6 doses), 1 syringe with a needle, 6 removable spray nozzles and instructions for use in a pack of cardboard box.

Storage conditions:

Conditions of storage and transportation. The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C in a place inaccessible to children. Freezing is not allowed.

Shelf life:

1 year. After the expiration date, the drug is not applicable.

Terms of leave from pharmacies:On prescription
Registration number:LSR-007988/09
Date of registration:13.10.2009 / 25.10.2013
Expiration Date:Unlimited
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Representation: & nbspMICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Information update date: & nbsp26.10.2017
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