Immunoglobuline antitetanus human (Solution) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J06BB02 (Immunoglobuline antitetanus human)

Dosage Form

Immunoglobuline antitetanus human

Solution for intramuscular injection 250 IU/1 dose: amp. 10 pcs.

Dosage Form, Packaging, and Composition

1 dose – ampoules (10) – cardboard packs.
1 dose – ampoules (10) with an ampoule knife or scarifier – cardboard packs.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

A concentrated solution of a purified immunologically active protein fraction, isolated by fractionation with ethyl alcohol at a temperature below 0°C from the plasma of donors immunized with tetanus toxoid.

Contains IgG with antibody activity that neutralizes tetanus toxin.

Pharmacokinetics

C_max of antibodies in the blood is reached after 24 hours. T_1/2 of antibodies from the body is 3-4 weeks.

Indications

Emergency prophylaxis of tetanus in adults and children who have not received a full course of immunization with tetanus toxoid or with an unknown vaccination history.

ICD codes

Dosage Regimen

It is administered intramuscularly, as a single dose into the upper outer quadrant of the gluteal muscle or into the outer surface of the thigh at a dose of at least 250 IU (contents of 1 ampoule) regardless of age.

Before injection, the ampoule with the drug is kept for 2 hours at a temperature of 18-22°C (64-72°F).

To avoid foam formation, the drug is drawn into the syringe with a needle with a wide lumen (a different needle is used for the injection).

The drug in an opened ampoule must not be stored.

Adverse Reactions

Rarely: local reactions (skin hyperemia, pain at the injection site), low-grade fever up to 37.5°C (99.5°F) within the first 24 hours after administration, allergic reactions (up to anaphylactic shock).

Contraindications

Hypersensitivity (including to human blood products).

With caution allergic diseases (bronchial asthma, atopic dermatitis, recurrent urticaria), tendency to allergic reactions.

Special Precautions

It is prohibited to administer the drug intravenously.

Procedure rooms must be equipped with anti-shock therapy means. Patients must be under medical supervision for at least 30 minutes after administration of the drug.

For individuals with allergic diseases or those who have had clinically significant allergic reactions in their history, the administration of antihistamines is recommended on the day of drug administration and for the subsequent 3-8 days.

For individuals with autoimmune diseases (blood diseases, connective tissue diseases, etc.), the drug should be administered against the background of appropriate therapy.

Active immunization against measles, mumps, rubella, and tetanus is carried out no earlier than 3 months after the end of the course of therapy.

Data on the administration of the drug are recorded in the appropriate registration forms indicating the batch number, manufacturing date, expiration date, manufacturer, dose and date of administration, and the nature of the reaction to the administration.

The drug in ampoules with damaged integrity or labeling, with changed physical properties (change in color, solution turbidity, presence of non-dispersible flakes), expired shelf life, or improper storage is not suitable for use.

Drug Interactions

Pharmaceutically incompatible with other medicinal products. Reduces the effectiveness of active immunization (with live vaccines).

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.