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The active substances are per dose (0.5 ml)1: Diphtheria Toxoid not less than 20 IU2; Tetanus Toxoid not less than 40 IU2,3; Bordetella pertussis antigens [Pertussis Toxoid 25 micrograms; Filamentous Haemagglutinin 25 micrograms]; Poliovirus (Inactivated)4 [Type 1 (Mahoney) 40 D antigen units5; Type 2 (MEF-1) 8 D antigen units5; Type 3 (Saukett) 32 D antigen units5]; Hepatitis B surface antigen6 10 micrograms; Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) 12 micrograms conjugated to Tetanus protein 22-36 micrograms.
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al3+).
2 IU International Unit.
3 Or equivalent activity determined by an immunogenicity evaluation.
4 Produced on Vero cells.
5 Equivalent antigenic quantity in the vaccine.
6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology.
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.
Excipients/Inactive Ingredients: Disodium hydrogen phosphate, potassium dihydrogen phosphate, trometamol, saccharose, essential amino acids including L-phenylalanine, sodium hydroxide and/or acetic acid and/or hydrochloric acid (for pH adjustment), and water for injections.
