Infanrix Hexa Description

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 (polyribosylribitol phosphate, PRP)³ 10 micrograms. 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.
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.
Potassium chloride, disodium phosphate, monopotassium phosphate, polysorbate 20 and 80, glycine, formaldehyde, neomycin sulphate, polymyxin B sulphate are present as residues from the manufacturing process.