Rabivac-Vnukovo-32 (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07BG01 (Rabies virus inactivated whole)

Active Substance

Rabies vaccine (USP Pharmacopoeia)

Dosage Form

Rabivac-Vnukovo-32

Lyophilisate for preparation of solution for subcutaneous and intramuscular administration 0.5 IU/dose: amp. 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Solvent water for injections

0.5 IU – ampoules (5) in a set with solvent 3 ml amp. (5 pcs.) – cardboard packs.

Clinical-Pharmacological Group

Vaccine for the prevention of rabies

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine induces the development of humoral and cellular immunity to the rabies virus.

Indications

Therapeutic-prophylactic and prophylactic immunization in cases of suspected infection with the rabies virus.

ICD codes

Dosage Regimen

Reconstitute the lyophilisate immediately before use with the provided 3 ml solvent (water for injections).

For therapeutic-prophylactic immunization after bites or injuries from animals suspected of rabies, administer the vaccine immediately on day 0, then on days 3, 7, 14, 30, and 90.

For prophylactic immunization of high-risk individuals, administer the vaccine on days 0, 7, and 30. Administer a single booster dose one year later, followed by subsequent boosters every 3 years.

Administer the vaccine intramuscularly into the deltoid muscle for adults and older children; for young children, administer into the anterolateral thigh. The subcutaneous route is also permitted.

The standard dose is 1.0 ml of the reconstituted vaccine per administration, regardless of the patient’s age.

Do not administer the vaccine into the gluteal region. Do not use if the reconstituted solution is cloudy or contains particulate matter.

Adverse Reactions

Administration of the rabies vaccine may in some cases be accompanied by a local or general reaction.

Local reactions: slight swelling, hyperemia, itching, enlargement of regional lymph nodes are possible.

General reactions: malaise, headache, dizziness, nausea, weakness, increased body temperature are possible. If neurological symptoms appear, the patient should be urgently hospitalized.

Contraindications

There are no contraindications for therapeutic-prophylactic immunization, as immunization is carried out for vital indications.

Contraindications for prophylactic immunization are: acute infectious and non-infectious diseases (vaccinations are carried out after recovery); cardiovascular failure of the 2nd and 3rd degree; chronic diseases of the kidneys, liver, endocrine system; systemic connective tissue diseases and allergic reactions to previous administration of a drug containing the vaccine (including angioedema, generalized rash, bronchial asthma); history of hypersensitivity to antibiotics; pregnancy.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is possible only for therapeutic and prophylactic purposes for vital indications.

Prophylactic immunization is contraindicated during pregnancy.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Local treatment of wounds, scratches, and abrasions is extremely important and must be carried out immediately or as soon as possible after a bite or injury.

The vaccinated person must be under medical supervision for at least 30 minutes. Vaccination sites must be equipped with anti-shock therapy means. The performed vaccination is registered in the established accounting forms indicating the name of the drug, dose, date of administration, manufacturer, batch number, and reaction to the administration.

After the administration of rabies immunoglobulin from horse serum, complications may occur: anaphylactic shock, local allergic reaction occurring 1-2 days after administration; serum sickness, which most often occurs on the 6th-8th day.

Drug Interactions

Combined use with rabies immunoglobulin (RIG) is possible in accordance with established schemes.

During the course of therapeutic-prophylactic immunization, vaccination with other drugs is prohibited.

After the completion of rabies vaccination, vaccinations with other vaccines are allowed no earlier than 2 months later. Prophylactic vaccination is carried out no earlier than 1 month after vaccination against another infectious disease.

During the course of therapeutic-prophylactic immunization, the prescription of immunosuppressants and corticosteroids is carried out only for vital indications.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.