Inactivated influenza vaccine eluated centrifugal liquid influenza Vaccine (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BB01 (Influenza virus inactivated whole)

Active Substance

Inactivated influenza vaccine (Grouping name)

Dosage Form

Inactivated influenza vaccine eluated centrifugal liquid (Influenza vaccine)

Subcutaneous administration suspension 0.5 ml/1 dose: syringes 1 pc. or amp. 10 pcs.

Dosage Form, Packaging, and Composition

Excipients : albumin sol. for inf. 10% and 20%, thiomersal 50±7.5 mcg.

0.5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
0.5 ml – ampoules (10) – cardboard boxes.
0.5 ml – syringes (1) – contour cell packs (1) – cardboard packs.

Clinical-Pharmacological Group

Influenza vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

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

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

Indications

• Influenza prophylaxis in adults over 18 years of age.

ICD codes

Dosage Regimen

Vaccinations are carried out in the autumn-winter period.

Annual vaccination is primarily recommended for individuals at high risk of complications and for individuals whose occupations pose a high risk of contracting influenza or infecting others:

• Persons over 60 years of age;
• Persons suffering from chronic somatic diseases;
• Persons frequently affected by acute respiratory infections;
• Medical workers;
• Workers in the service sector, transport, and educational institutions.

The vaccine is administered once, subcutaneously, at a dose of 0.5 ml, into the area of the outer surface of the upper arm several centimeters below the shoulder joint.

Before use, the ampoule with the drug must be shaken thoroughly.

The drug in ampoules with damaged integrity or labeling, with altered physical properties (color, transparency, homogeneity), with an expired shelf life, or improper storage is not suitable for use.

The opening of ampoules and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis.

The drug in an opened ampoule must not be stored.

The performed vaccination is recorded in the established registration forms, indicating the date of administration, dose, batch number, and the name of the manufacturer.

Adverse Reactions

Upon administration of the drug, some vaccinated individuals may experience general reactions in the form of malaise, headache, and increased body temperature.

No more than 3% of reactions exceeding 37.5°C (99.5°F) (including no more than 0.5% exceeding 38.5°C (101.3°F)) are allowed, registered within the first two days after immunization, and lasting no more than three days.

Local reactions (redness and swelling) occur in most vaccinated individuals; some vaccinated individuals may develop limited infiltrates.

The development of an infiltrate up to 50 mm in size is allowed in no more than 3% of cases. The duration of local reactions does not exceed 5 days.

Contraindications

• Allergic reactions to chicken eggs and hypersensitivity to chicken protein;
• Reaction or post-vaccination complication to previous administration of seasonal influenza vaccines;
• Acute infectious and non-infectious diseases, chronic diseases in the acute stage – vaccinations are carried out no earlier than one month after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal diseases, vaccination is carried out after temperature normalization;
• Systemic diffuse connective tissue diseases;
• Adrenal gland diseases;
• Hereditary, degenerative, and progressive diseases of the nervous system;
• Pregnancy and lactation.

The possibility of vaccinating individuals suffering from chronic diseases not listed in the contraindications is determined by the attending physician, based on the patient’s condition.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Used in adults over 18 years of age.

Geriatric Use

Annual vaccination is primarily recommended for individuals at high risk of complications and for individuals whose occupations pose a high risk of contracting influenza or infecting others, for example, persons over 60 years of age.

Special Precautions

Precautions for use

All persons subject to vaccination must be examined by a doctor, taking into account anamnestic data.

On the day of vaccination, the vaccinees must be examined by a doctor with mandatory temperature measurement. Vaccination is not performed at a temperature above 37°C (98.6°F). The doctor is responsible for the correct prescription of the vaccination.

After vaccination, the vaccinated person must remain under medical supervision for at least 30 minutes. The vaccination site must be equipped with anti-shock therapy means.

Information on the possible effect of the medicinal product on the ability to drive vehicles, mechanisms.

Not established.

Overdose

Cases of overdose have not been established.

Drug Interactions

The influenza vaccine can be used simultaneously with other vaccines from the National Calendar of Preventive Vaccinations and inactivated vaccines from the Calendar of Preventive Vaccinations for Epidemic Indications, administered to adults. In this case, contraindications to each of the vaccines used must be taken into account, and the drugs must be administered into different parts of the body using different syringes.

Storage Conditions

Store in accordance with SP 3.3.2.1248-03 at a temperature of 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

For medical and preventive institutions. Dispensing of the vaccine in disposable syringes by prescription is allowed.

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.