Q-fever vaccine M-44 live (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BX (Other viral vaccines)

Dosage Form

Q-fever vaccine M-44 live

Lyophilizate for preparation of suspension for cutaneous scarification application 10 doses/amp.: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of suspension for cutaneous scarification application in the form of an amorphous mass, which is a tablet of pink color with a grayish, yellowish, or brownish tint.

Components of the drying medium: sucrose 1 %, pasteurized drinking milk 49 %.
Solvent: sodium chloride injection 0.9 %.

10 doses – ampoules (5) in a kit with solvent 5 ml amp. 5 pcs. – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of Q fever

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

A single administration of the vaccine is accompanied by the development of specific immunity 3-4 weeks after vaccination.

Indications

Specific prophylaxis of Q fever is carried out from the age of 14 years.

Contingents subject to vaccination

• Persons engaged in the procurement, storage, processing of raw materials and livestock products obtained from farms where Q fever diseases in cattle are registered;
• Persons engaged in the procurement, storage and processing of agricultural products in territories enzootic for Q fever;
• Persons working with live cultures of Q fever pathogens.

ICD codes

Dosage Regimen

The vaccine is administered once by the cutaneous scarification method in a dose of 0.05 ml. Revaccination is carried out with a dose of 0.05 ml not earlier than 1 year after the primary vaccination for persons whose serum lacks specific complement-fixing antibodies.

Immediately before vaccination, 0.5 ml of sodium chloride injection 0.9% is added to the ampoule with the vaccine. The vaccine should dissolve within 2 minutes to form a thick homogeneous suspension of pink color with a grayish, yellowish, or brownish tint.

The vaccination site (the outer surface of the middle third of the shoulder) is treated with a 70% alcohol solution or ether (the use of other disinfectant solutions is not allowed). After they evaporate, using an eye dropper or a syringe through a needle, apply 2 drops of the diluted vaccine at a distance of 30-40 mm. Using a sterile scarifier, through each drop of vaccine applied to the skin, make three cross-shaped incisions 8-10 mm long at a distance of 3-4 mm from each other so that blood appears in small “dewdrops”. Rub the vaccine into the incisions with the flat side of the scarifier, after which the vaccine should dry for 5-10 minutes. Subsequent treatment of the vaccination site is not carried out.

The dissolved vaccine is suitable for use within 30 minutes when stored under a sterile napkin at room temperature and within 60 minutes when stored at a temperature of 2 to 10°C (50°F).

The administration of the drug is recorded in the established accounting forms indicating the date of administration, dose, manufacturer, batch number, and reaction to the vaccination.

Adverse Reactions

A general reaction to the vaccination develops on the 2nd-3rd day in some vaccinated individuals and is expressed in a one-day malaise, chills, headache, and an increase in temperature to 37.5°C (99.5°F).

A local reaction, characterized by redness and nodular swelling along the incisions, usually develops in at least 90% of vaccinated individuals. The duration of the local reaction is 3-4 days.

Contraindications

• Acute infectious and non-infectious diseases; chronic diseases in the acute phase; vaccinations are carried out no earlier than one month after recovery or remission;
• Allergic diseases (according to anamnesis): bronchial asthma, atopic dermatitis, hay fever, etc.; allergy to chicken egg;
• Chronic diseases of the upper respiratory tract and lungs;
• Systemic connective tissue diseases;
• Immunodeficiency states (primary and secondary);
• Pregnancy and lactation period;
• Malignant diseases.

The possibility of vaccinating persons suffering from diseases not listed in this list of contraindications is determined by the doctor, based on the health status of the person to be vaccinated.

Immediately before vaccination, the doctor conducts a thorough medical examination with thermometry and interviews the vaccinees to identify contraindications. At a temperature above 37°C (98.6°F), vaccinations are not carried out.

Use in Pregnancy and Lactation

Use during pregnancy and lactation is contraindicated.

Special Precautions

Precautions for use

Before use, each ampoule with the vaccine is carefully inspected. The drug is unsuitable for use if the ampoule has cracks, foreign inclusions, color uncharacteristic of the vaccine, and other defects, as well as damaged labeling and expired shelf life.

Special precautions for the destruction of unused medicinal product

Unused vaccine, as well as rejected ampoules, are opened and neutralized by immersion in disinfectant solutions (3% chloramine solution or 3% sodium hydroxide solution, or 6% hydrogen peroxide solution, or 1% Biodez extra solution for 1 day) and boiling for 1 hour.

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

Information is absent.

Overdose

Not established.

Drug Interactions

Vaccinations are carried out no earlier than 1 month after the previous immunization with other vaccines. Simultaneous vaccinations with vaccines against Q fever and brucellosis are allowed. The brucellosis vaccine is administered in accordance with the instructions for use of the drug into the other arm.

Storage Conditions

Store and transport in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Freezing is not allowed.

Keep out of reach of children.

Shelf Life

Shelf life 2 years.

Dispensing Status

For therapeutic-prophylactic and sanitary-prophylactic 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.