Purified liquid adsorbed diphtheria-tetanus toxoid with reduced antigen content

Description

Administration of the preparation in accordance with the approved schedule leads to the development of specific antitoxic immunity to diphtheria.

Presentation

Suspension for intramuscular and subcutaneous injections (with preservative), 0.5 ml ampoules (1 vaccination dose) or 1 ml ampoules (2 vaccination doses) Suspension for intramuscular and subcutaneous injections (without preservative), 0.5 ml ampoules (1 vaccination dose) 10 ampoules in the box with a package insert and an ampoule cutter, or 5 ampoules in PVC dose trays, 2 dose trays in each package with a package insert and an ampoule cutter. If the ampoule has a score line, a ring or a dot, an ampoule cutter is not inserted.

Ingredients

ADT-M-toxoid consists of a mixture of purified diphtheria and tetanus toxoid adsorbed on aluminum hydroxide

1 dose (0.5 ml) contains:

Toxoid with preservative:

• diphtheria toxoid – 5 flocculating units (Lf);
• tetanus toxoid - 5 binding units (BU);

Excipients:

• aluminum hydroxide (equivalent to aluminum) - not more than 0.55 mg;
• thiomersal – 42.5 to 57.5 µg;
• formaldehyde - not more than 50 µg;

Toxoid without preservative:

• diphtheria toxoid – 5 flocculating units (Lf);
• tetanus toxoid - 5 binding units (BU);

Excipients:

• aluminum hydroxide (equivalent to aluminum) - not more than 0.55 mg;
• formaldehyde - not more than 50 µg;

The specific activity of diphtheria toxoid is not less than 1500 Lf/mg of protein nitrogen, tetanus toxoid – not less than 1000 BU/mg of protein nitrogen.

Indications

Prevention of diphtheria and tetanus in children, adolescents and adults.