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One dose1 (0.5 mL) contains: 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 aluminum hydroxide, hydrated (0.6 mg Al3+).
2 As lower confidence limit (p=0.95).
3 Or equivalent activity determined by an immunogenicity evaluation.
4 Produced on Vero cells.
5 Or equivalent antigenic quantity determined by a suitable immunochemical method.
6 Produced in yeast Hansenula polymorpha cells by recombinant DNA technology.
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see Contraindications).
Excipient with known effect: Phenylalanine 85 micrograms. (See Precautions.)
Excipients/Inactive Ingredients: Disodium hydrogen phosphate, Potassium dihydrogen phosphate, Trometamol, Saccharose, Essential amino acids including L-phenylalanine, Sodium hydroxide, acetic acid or hydrochloric acid (for pH adjustment), Water for injections.
