Ultravac^® live allantoic influenza vaccine (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BB03 (Influenza virus live attenuated)

Active Substance

Influenza vaccine, live

Dosage Form

Ultravac® Influenza vaccine allantoic live

Lyophilizate for preparation of solution for intranasal administration 0.5 ml/1 dose: amp. 1 pc. in a set with solvent (amp. 1 pc.) and a single-use spray-dispenser

Dosage Form, Packaging, and Composition

Excipients: stabilizer M-2 (sucrose – 15 mg, lactose – 6 mg, glycine – 3 mg, sodium glutamate – 3 mg, trometamol – 0.3 mg, sodium chloride – 0.3 mg, gelatin – 3 mg).

Solvent: water for injections – 1 ml.

0.5 ml (1 dose) – glass ampoules (1) in a set with solvent (amp. 1 pc.) and a single-use spray-dispenser – cardboard packs.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

Vaccines; viral vaccines; influenza vaccines

Pharmacological Action

The vaccine induces the formation of specific immunity against influenza types A and B.

The protective effect of the vaccine usually begins 3 weeks after vaccination and lasts for 10-12 months.

Indications

• Active prophylaxis of influenza in adults without age limit and in children from 3 years of age.

Vaccination is primarily recommended for individuals at high risk of complications and for individuals who, due to their profession, are at high risk of contracting influenza or infecting others: persons over 60 years of age, persons suffering from chronic somatic diseases, frequently ill with acute respiratory infections; preschool children, schoolchildren, healthcare workers, service sector workers, transport workers, educational institution workers.

ICD codes

Dosage Regimen

Vaccination is carried out once in the autumn-winter period annually.

The vaccine is administered intranasally using a spray dispenser (SD). Immediately before the start of vaccinations, the contents of the ampoule are dissolved in 0.5 ml of solvent.

The vaccine should dissolve within 3 minutes. The dissolved preparation is a clear or slightly opalescent liquid. 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.

A single-use spray-dispenser (SD) is used for the administration of the single-dose vaccine.

The spray-dispenser consists of a sterile syringe with a scale of divisions of 40 and 100 units (in volumetric ratio the scales are identical), a sterile needle and one removable spray nozzle for creating a fine suspension.

Method of application for vaccination

1. Put the needle on the syringe, fill it with solvent (water for injections) in a volume of 0.5 ml at room temperature.
2. To dilute the vaccine, fill the opened ampoule with water from the syringe.
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 spray nozzle.
5. Bring the spray nozzle close to the nasal passage and, with a sharp press on the syringe plunger, inject the vaccine into the nasal passage.
6. Remove the spray nozzle, put on the needle and fill the syringe with the remaining preparation in the ampoule (0.25 ml).
7. Remove the needle, again firmly put on the spray nozzle and administer the preparation into the other nasal passage in accordance with point 5.

The spray nozzle is inserted to a depth of 0.5 cm into the nasal passages, previously cleared of mucus. The person being vaccinated is in a sitting position with the head slightly tilted back. After administration of the vaccine, 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.

Subsequent vaccinations can be carried out with any influenza vaccine in the autumn-winter period of the next year in accordance with the Instructions for Use of the drug.

Adverse Reactions

Within 4 days after vaccination, the following are possible: 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 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 temperature normalization);
• Chronic diseases in the phase of exacerbation or decompensation;
• Increased sensitivity to chicken protein;
• Reaction or post-vaccination complication to previous administration;
• Immunodeficiency state (primary), immunosuppression;
• Malignant neoplasms;
• Rhinitis;
• Pregnancy.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy.

Use in Hepatic Impairment

Chronic diseases in the stage of exacerbation or decompensation are a contraindication for vaccination.

Use in Renal Impairment

Chronic diseases in the stage of exacerbation or decompensation are a contraindication for vaccination.

Pediatric Use

Used in children from 3 years of age.

Geriatric Use

Can be used according to indications.

Special Precautions

All persons subject to vaccination must be examined by a doctor (paramedic) taking into account anamnesis data. On the day of vaccination, the vaccinees must be examined by a doctor (paramedic) with mandatory thermometry. At a temperature above 37°C (98.6°F), vaccinations are 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.

Overdose

Data on overdose of Ultravac^® vaccine have not been provided.

Drug Interactions

Within 2 days after vaccination, the use of any medicinal products administered intranasally is not recommended.

Storage Conditions

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 – 1 year. Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed 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.