Purified adsorbed liquid tetanus toxoid for donors AC-toxoid for donors (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07AM01 (Tetanus toxoid)

Active Substance

Anatoxinum tetanicum purificatum adsorptum fluidum (SP State Pharmacopoeia)

Dosage Form

Anatoxinum tetanicum purificatum adsorptum fluidum for donors (AC-toxoid for donors)

Suspension for subcutaneous administration 1 dose/1 ml: amp. 1 ml 10 pcs.

Dosage Form, Packaging, and Composition

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

	1 dose (1 ml)
Tetanus toxoid	40 EU*

* Specific activity of tetanus toxoid is not less than 1000 EU/mg of protein nitrogen.

Excipients: aluminum hydroxide (in terms of aluminum Al³⁺) – not more than 1.1 mg, thiomersal (preservative) – from 85 to 115 mcg, formaldehyde – not more than 200 mcg.

1 ml – ampoules (10) – cardboard boxes.

Clinical-Pharmacological Group

Immunological preparation. Toxoid

Pharmacotherapeutic Group

MIBP-toxoid

Pharmacological Action

It induces the formation of specific immunity against tetanus. One immunizing dose contains 10 antitoxin-binding units (EU) of tetanus toxoid, which corresponds to not less than 40 IU.

Indications

Active immunization against tetanus according to the schedule of routine vaccinations; emergency prophylaxis of tetanus.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A35	Other forms of tetanus
Z23.5	Need for immunization against tetanus alone

ICD-11 code	Indication
1C13	Tetanus
QC00.5	Need for immunization against tetanus alone

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Active immunization is carried out in individuals not previously vaccinated against tetanus and consists of two vaccinations with an interval of 30-40 days and a revaccination after 6-12 months, using 1 dose of toxoid each time. Subsequent revaccinations are performed once every 10 years as a single dose. For emergency prophylaxis, the toxoid is administered with tetanus antitoxin serum. The dose and frequency of administration are determined individually, depending on the clinical situation. The toxoid is administered subcutaneously into the subscapular region.

Adverse Reactions

Possible weakness, malaise, headache, fever (these symptoms usually disappear within 24-48 hours).

In very rare cases anaphylactic shock.

Local reactions redness, swelling, pain at the injection site.

Contraindications

There are no contraindications for emergency prophylaxis. For routine vaccination – acute infectious diseases and chronic diseases in the acute phase.