Purified liquid adsorbed diphtheria-tetanus toxoid with reduced antigen content

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.