Immunoglobuline antitetanus from human serum (Solution) Instructions for Use

Marketing Authorization Holder

Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd (China)

ATC Code

J06BB02 (Human tetanus immunoglobulin)

Dosage Form

Immunoglobuline antitetanus from human serum

Solution for intramuscular injection 100 IU/ml: fl. 2.5 ml or 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Solution for intramuscular injection transparent or slightly opalescent, colorless or light yellow in color.

Excipients: glycine (stabilizer) – 20-25 mg, sodium chloride – 7 mg, water for injection.

2.5 ml – glass bottles (1) – cardboard boxes.
5 ml – glass bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Immunological preparation. Immunoglobulin

Pharmacotherapeutic Group

MIBP-globulin

Pharmacological Action

The active principle of the drug is immunoglobulins class G, which possess the activity of antibodies that neutralize tetanus toxin.

Pharmacokinetics

C_max of antibodies in the blood is reached after 24 – 48 hours after administration. T_1/2 of antibodies from the body is 3-4 weeks.

Indications

• Prophylaxis and treatment of tetanus, especially in case of increased sensitivity of the patient to the administration of tetanus toxoid.

ICD codes

Dosage Regimen

Immunoglobuline antitetanus from human serum is administered intramuscularly into the anterolateral region of the thigh.

Before injection, the vial with the drug is kept for 2 hours at a temperature from 18 to 22°C (71.6°F). Opening of vials and the administration procedure are carried out with strict adherence to the rules of asepsis and antisepsis. To avoid foam formation, the drug is drawn into a syringe with a needle with a wide lumen; another needle is used for the injection. The drug in an opened vial is not subject to storage. The drug is not suitable for use in vials with damaged integrity or labeling, with changed physical properties (change in color, cloudiness of the solution, presence of non-dispersible flakes), with an expired shelf life, or improper storage.

A skin test before administration is not required.

Dosage.

1. Prophylactic dose: one adult or pediatric dose contains 250 IU.
2. In case of a large area of injury and heavy wound contamination, a single dose can be doubled.
3. Therapeutic dose: from 3000 to 6000 IU, should be divided and administered into different areas of the body.

Adverse Reactions

Reactions to the administration of human tetanus immunoglobulin are generally absent. In rare cases, local reactions may develop in the form of slight hyperemia and pain at the injection site. An increase in body temperature to 37.5°C (99.5°F) is possible during the first 24 hours after drug administration. In some individuals with altered reactivity, allergic reactions may develop, and in exceptional cases, anaphylactic shock. In this regard, persons who have received the drug should be under medical supervision for at least 30 minutes. Procedure rooms where immunoglobulin is administered must be equipped with anti-shock therapy means.

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

Contraindications

• Hypersensitivity to drugs containing human immunoglobulin.

Special Precautions

It is prohibited to administer the drug intravenously.

The use of the drug is not allowed in case of sediment that does not disappear upon shaking, as well as foreign formations, cracks on the vial, or a loosely closed vial cap.

After opening the vial, the prescribed dose must be used immediately. The remainder of the drug in the vial is not subject to use.

Drug Interactions

During emergency prophylaxis with tetanus toxoid and immunoglobulin, the drugs should be administered into different areas of the body using different syringes. Immunoglobuline antitetanus from human serum should not be mixed with other drugs.

Immunoglobuline antitetanus from human serum within the subsequent three months after administration may hinder the development of a full immune response to the administration of live vaccines against measles, mumps, and chickenpox.

Storage Conditions

At a temperature from 2°C (35.6°F) to 8°C (46.4°F) in a place protected from light. Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

For medical and preventive 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.