Purified liquid adsorbed diphtheria-tetanus toxoid with reduced antigen content
Trade name
ADT-M-toxoid
Dosage form
Suspension for intramuscular and subcutaneous injections
Shelf life
3 years
Manufacturer
NPO Microgen, 177, Bratskaya str., Perm, Perm Territory, 614089 Russia; and 105 Novorossiyskaya str., Ufa, Republic of Bashkortostan, 450014 Russia
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.