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After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid1 not less than 30 International Units (IU). Tetanus toxoid1 not less than 40 International Units (IU). Bordetella pertussis antigens: Pertussis toxoid (PT)1 25 micrograms; Filamentous Haemagglutinin (FHA)1 25 micrograms; Pertactin (PRN)1 8 micrograms. Hepatitis B surface antigen (HBs)2,3 10 micrograms. Poliovirus (inactivated) (IPV): type 1 (Mahoney strain)4 40 D-antigen unit; type 2 (MEF-1 strain)4 8 D-antigen unit; type 3 (Saukett strain)4 32 D-antigen unit. Haemophilus influenzae type b polysaccharide 10 micrograms (polyribosylribitol phosphate, PRP)3, conjugated to tetanus toxoid as carrier protein approximately 25 micrograms.
1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+.
2produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology.
3adsorbed on aluminium phosphate (AlPO4) 0.32 milligrams Al3+.
4propagated in VERO cells.
The DTPa-HBV-IPV component is presented as a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. This is a normal observation.
The Hib component is presented as a white powder.
Excipients/Inactive Ingredients: Lactose, sodium chloride (NaCl), Medium 199 (as stabilizer containing amino acids, mineral salts and vitamins), water for injections.
Neomycin sulphate and polymyxin B sulphate are present as residues from the manufacturing process.
