Tetraanatoxin purified adsorbed (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AX (Other bacterial vaccines)

Dosage Form

Tetraanatoxin purified adsorbed

Subcutaneous suspension 1 dose/1 ml: 1 ml or 3 ml ampoule, 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for subcutaneous administration in the form of an opalescent liquid, white in color with a grayish, yellowish, or brownish tint; upon settling, it separates into a loose white precipitate or white with a grayish, yellowish, or brownish tint, which is easily broken up upon shaking, and a clear, colorless supernatant liquid.

* binding units.

Excipients: aluminum hydroxide (in terms of Al³⁺) – not more than 1.2 mg, thiomersal – 100±15 mcg, formaldehyde – not more than 100 mcg.

1 ml (1 dose) – ampoules (5) – contour cell packs (2) – cardboard packs.
1 ml (1 dose) – ampoules (10) – cardboard boxes.
3 ml (3 doses) – ampoules (10) – cardboard boxes.

Clinical-Pharmacological Group

Immunological preparation. Anatoxin

Pharmacotherapeutic Group

MIBP-anatoxin

Pharmacological Action

Administration of the drug in accordance with the approved schedule induces the formation of specific antitoxic immunity lasting for at least 5 years.

Indications

• Prevention of botulism and tetanus in persons aged from 16 to 60 years (women up to 55 years).

ICD codes

Dosage Regimen

The primary immunization course consists of three injections: double vaccination with an interval of 25-30 days and revaccination after 6-9 months. If it is necessary to extend the intervals, the next vaccination should be carried out as soon as possible.

Subsequent single revaccinations are carried out as indicated every 5 years.

The single dose of the drug is 1 ml.

The drug is administered subcutaneously into the subscapular area (1 cm from the lower angle of the scapula towards the posterior midline). Before use, the ampoule with the drug must be shaken thoroughly until a homogeneous suspension is obtained.

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

Adverse Reactions

Within the first two days after administration of the drug, general and local reactions may develop. The general reaction is manifested by fever, malaise; local reactions – by the appearance of skin hyperemia, soft tissue swelling or a small infiltrate, and in rare cases, the development of regional lymphadenitis. The presence of indurations at the site of the previous injection is not a contraindication for the next vaccination. In this case, the drug is administered on the side opposite to the site of the previous administration.

The possibility of anaphylactic shock developing in exceptional cases in certain highly sensitive individuals must be considered.

Contraindications

• Allergic reactions to previous administration of the drug or its components;
• Acute infectious and non-infectious diseases, exacerbation of chronic diseases, infectious and non-infectious diseases of the central nervous system in the medical history. Vaccinations are carried out no earlier than one month after recovery (remission);
• Blood diseases;
• Diseases of the endocrine system;
• Diseases of the circulatory system;
• Bronchial asthma and other allergic diseases, severe allergic reactions to food, medicinal and other substances;
• Systemic lupus erythematosus and other connective tissue diseases;
• Malignant neoplasms;
• Pregnancy, lactation period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Special Precautions

Precautions for use

The drug in ampoules with damaged integrity, missing labeling, altered physical properties (change in color, presence of non-dispersible flakes), expired shelf life, or improper storage is unsuitable for use.

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.

Considering the possibility of anaphylactic shock, medical supervision of vaccinated individuals should be ensured for 30 minutes after administration of the drug. Vaccination sites must be equipped with means for anti-shock therapy, including adrenaline (epinephrine).

Effect on ability to drive vehicles and machinery

No information available.

Overdose

Not established.

Drug Interactions

The drug can be administered simultaneously (with different syringes into different parts of the body) with tick-borne encephalitis vaccine and tularemia vaccine. Persons fully vaccinated against tetanus are recommended to be administered botulinum anatoxin. The interval from previous vaccinations against other infections should be at least one month.

Storage Conditions

In accordance with SP 3.3.2.1248-03 at a temperature from 2 to 8°C (46.4°F). Keep out of reach of children. Do not freeze.

Shelf Life

Shelf life – 3 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.