Influvir Monovalent influenza vaccine alive (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BB (Anti-influenza vaccines)

Active Substance

Influenza vaccine, alive

Influenza vaccine, alive (Grouping name)

Dosage Form

Influvir Monovalent influenza vaccine alive

Lyophilisate for preparation of solution for intranasal administration 0.5 ml/1 dose: amp. 1 dose (0.5 ml) or 6 doses (3 ml)

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intranasal administration in the form of a white amorphous mass.

* The strain composition of the vaccine is changed annually in accordance with the epidemic situation and WHO recommendations.

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

0.5 ml (1 dose) – ampoules (1) in a kit with 1 syringe and 1 removable spray nozzle – cardboard packs.
1 ml (2 doses) – ampoules (1) in a kit with 1 syringe and 2 removable spray nozzles – cardboard packs.
1.5 ml (3 doses) – ampoules (1) in a kit with 1 syringe and 3 removable spray nozzles – cardboard packs.
3 ml (6 doses) – ampoules (1) in a kit with 1 syringe and 6 removable spray nozzles – cardboard packs.
1 ml (2 doses) – ampoules (250) in a kit with syringes and removable spray nozzles – cardboard boxes.
1.5 ml (3 doses) – ampoules (250) in a kit with syringes and removable spray nozzles – cardboard boxes.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

Vaccines; viral vaccines; influenza vaccines

Pharmacological Action

Influenza live monovalent vaccine.

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

Indications

• Specific prophylaxis of influenza type A/H₁N₁/.

ICD codes

Dosage Regimen

The vaccine is administered intranasally.

Immediately before vaccination, the contents of the ampoule are dissolved at room temperature in the corresponding volume of solvent (0.5 ml; 1.0 ml; 1.5 ml or 3.0 ml for the vaccine with 1, 2, 3 doses or 6 doses, respectively). The vaccine should dissolve completely within 3 minutes.

The dissolved preparation is a clear or slightly opalescent liquid. The dissolved vaccine must be used within 30 minutes.

The preparation in ampoules with damaged integrity, labeling, as well as with changed physical properties (color, transparency), or in case of improper storage is not suitable for use.

The vaccine is administered into the nasal passages at the rate of 0.25 ml into each nostril.

For the administration of the vaccine in the form of a fine-dispersion spray, a sprayer-dispenser is used, consisting of a sterile syringe, a sterile needle and one removable single-use nozzle included in the vaccine kit.

The sprayer-dispenser (removable nozzle) is inserted to a depth of 0.5 cm into the nasal passages, previously cleared of mucus. The person to be vaccinated should be in a sitting position with the head slightly tilted back. After the vaccine administration, the vaccinated person should remain in this position for 1 minute.

Instructions for use

1. Put the needle on the syringe, fill it with solvent (purified water or boiled water at room temperature).
2. Introduce the solvent (0.5; 1.0; 1.5 or 3.0 ml according to the vaccine release form) from the syringe into the opened ampoule with the vaccine.
3. After dissolution, fill the syringe with the preparation in a volume of 0.25 ml (mark 10 on the 40-unit scale or mark 25 on the 100-unit scale).
4. Remove the needle and firmly put on the removable nozzle.
5. Bring the sprayer-dispenser close to the nasal passage and inject the vaccine into the nasal passage by pressing the syringe plunger sharply.
6. Remove the sprayer-dispenser, put on the needle and fill the syringe with the next dose of the preparation (0.25 ml).
7. Remove the needle, firmly put on the same sprayer-dispenser again and administer the preparation into the other nasal passage according to point 5.

For subsequent vaccinations (release form more than 1 dose per ampoule), repeat the actions described in paragraphs 3-7, with mandatory change of the removable nozzle for each subsequent person to be vaccinated.

Adverse Reactions

Within 4 days after vaccination, some vaccinated individuals may experience: temperature rise to 37.5°C (99.5°F), mild malaise, headache, minor catarrhal symptoms. The presence of reactions with a temperature rise above 37.5°C (99.5°F) is allowed in no more than 2% of vaccinated individuals. The duration of the temperature reaction should not exceed 3 days.

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., vaccination is carried out after the temperature normalizes;
• Chronic diseases in the stage of exacerbation or decompensation;
• Hypersensitivity to chicken protein. Reaction or post-vaccination complication to previous administration of seasonal influenza vaccines;
• Immunodeficiency state (primary), immunosuppression, malignant neoplasms;
• Diseases of the nasopharynx in the acute stage;
• Pregnancy and lactation.

All persons subject to vaccination must be examined by a doctor (paramedic) taking into account anamnestic data. On the day of vaccination, the persons to be vaccinated must be examined by a doctor (paramedic) with mandatory thermometry. At a temperature above 37°C (98.6°F), vaccination is not carried out. The doctor (paramedic) is responsible for the correct prescription of the vaccination. The performed vaccination is registered in the established accounting forms indicating the date, manufacturer of the drug, batch number, reaction to the vaccination.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 18 years of age.

Geriatric Use

Contraindicated in the elderly over 60 years of age.

Special Precautions

The vaccinated person should be isolated for 3 days from infants in the first half of the year of life and from persons with primary and severe secondary immunodeficiency states.

Drug Interactions

It is not recommended to use any intranasally administered medicines for 2 days after vaccination.

Storage Conditions

The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature from 2 to 8°C (46.4°F) in a place inaccessible to children. Freezing is not allowed.

Shelf Life

Shelf life – 1 year.

Dispensing Status

Vaccine in ampoules of 1 dose – by prescription. Vaccine in ampoules of 2, 3, 6 doses – for medical and preventive institutions.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.