Ultragrivac^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BB (Anti-influenza vaccines)

Active Substance

Avian influenza vaccine, live

Dosage Form

Ultragrivac® Influenza live vaccine

Lyophilizate for preparation of solution for intranasal administration 0.5 ml/1 dose: amp. 0.5 ml (1 dose) in set with solvent, syringe, and applicator

Dosage Form, Packaging, and Composition

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

Excipients: stabilizer M-2 30.6 mg.

Solvent: water for injections – 1 ml.

EID₅₀ – mean embryo infective dose (a quantitative indicator of the virulence of an infectious disease pathogen, expressed by the value of the infective dose that, with a given route of infection, causes the development of the disease in 50% of experimental animals).

0.5 ml (1 dose) – glass ampoules (1) in a set with solvent 1 ml amp. 1 pc., syringe with needle in a contour non-cell packaging and applicator Actuators-183.016 – cardboard packs.
3 ml (6 doses) – glass ampoules (1) in a set with solvent 5 ml amp. 1 pc., syringe with needle in a contour non-cell packaging and 6 applicators Actuators-183.016 – cardboard packs.
3 ml (6 doses) – glass ampoules (1) in a set with solvent 5 ml amp. 1 pc., syringe with needle and applicator Actuators-183.016 – contour cell packaging (1) – cardboard packs.
0.5 ml (1 dose) – glass ampoules (2500) – cardboard boxes.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces the formation of specific immunity in humans against avian influenza type A. The protective effect of the vaccine usually occurs 21 days after the second vaccination.

Indications

• Specific prophylaxis of avian influenza in humans.

Vaccination is recommended for epidemic indications for persons aged 18 to 60 years.

ICD codes

Dosage Regimen

The vaccine is administered intranasally twice with an interval of 10 days using a spray applicator.

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 dissolve completely within 3 minutes. The dissolved preparation is a colorless, slightly opalescent liquid.

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

The vaccine is administered into the nasal passages at a rate of 0.25 ml into each nostril. To administer the vaccine as a fine-dispersion mixture, a sterile syringe, a sterile needle, and one removable applicator Actuators-183.016 for single use, included in the vaccine kit, are used.

The spray tip 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 vaccine administration, the vaccinated person should remain in a sitting position with the head slightly tilted back for 1 minute. The dissolved vaccine must be used within 30 minutes.

Method of application for vaccination

1. Put the needle on the syringe, fill it with the solvent (water for injections) at 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 the solvent from the syringe.
3. After dissolution, fill the syringe with the preparation in a volume of 0.5 ml (mark 20 on the 80-unit scale or mark 50 on the 100-unit scale).
4. Remove the needle and firmly put on the removable applicator Actuators-183.016 (spray tip).
5. Bring the spray tip close to the nasal passage and, with sharp presses on the syringe plunger, inject the vaccine into each nasal passage, 0.25 ml each.

Adverse Reactions

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

Contraindications

• Acute infectious and non-infectious diseases;
• 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 breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Vaccination is recommended for epidemic indications for persons aged 18 to 60 years.

Geriatric Use

Vaccination is recommended for epidemic indications for persons aged 18 to 60 years.

Special Precautions

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

Acute infectious and non-infectious diseases are temporary contraindications for vaccination. Vaccination is carried out 2-4 weeks after recovery. For non-severe ARVI, acute intestinal diseases, etc., vaccination is carried out after temperature normalization.

Precautionary measures

The person to be vaccinated should be in a sitting position with the head slightly tilted back. After vaccine administration, the vaccinated person should remain in a sitting position with the head slightly tilted back for 1 minute. The dissolved vaccine must be used within 30 minutes.

Drug Interactions

Not established.

Storage Conditions

Do not use after the expiration date. The vaccine is stored and transported in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a dry place inaccessible to children. Freezing is not allowed. Transportation at a temperature from 9°C (48.2°F) to 25°C (77°F) for a duration of no more than 10 days is allowed.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

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.