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After reconstitution, 1 dose (0.5 mL) contains: Diphtheria toxoid1 not less than 30 International Units (IU) (25 Lf). Tetanus toxoid1 not less than 40 International Units (IU) (10 Lf). Bordetella pertussis antigens: Pertussis toxoid (PT)1 25 micrograms; Filamentous haemagglutinin (FHA)1 25 micrograms; Pertactin (PRN)1 8 micrograms. Poliovirus (inactivated) (IPV): type 1 (Mahoney strain)2 40 D-antigen unit; type 2 (MEF-1 strain)2 8 D-antigen unit; type 3 (Saukett strain)2 32 D-antigen unit. Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) (PRP) 10 micrograms. Conjugated to tetanus toxoid as carrier protein approximately 25 micrograms.
1adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5 milligrams Al3+.
2propagated in VERO cells.
The Infanrix-IPV component of the vaccine is a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed.
The Hib component of the vaccine is a white powder.
Excipients/Inactive Ingredients: Lactose, sodium chloride, Medium 199, water for injections.
Potassium chloride, disodium phosphate, monopotassium phosphate, polysorbate 80, glycine, formaldehyde, neomycin sulphate, polymyxin sulphate are present as residuals from the manufacturing process.
