Hexaxim Description

After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.
The active substances are per dose (0.5 mL)¹: Diphtheria Toxoid not less than 20 IU^2,4 (30Lf); Tetanus Toxoid not less than 40 IU^3,4 (10Lf); Bordetella pertussis antigens [Pertussis Toxoid 25 micrograms; Filamentous Haemagglutinin 25 micrograms]; Poliovirus (Inactivated)⁵ [Type 1 (Mahoney) 29 D antigen units⁶; Type 2 (MEF-1) 7 D antigen units⁶; Type 3 (Saukett) 26 D antigen units⁶]; Hepatitis B surface antigen⁷ 10 micrograms; Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) 12 micrograms conjugated to Tetanus protein 22-36 micrograms.
¹Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al³⁺).
²As lower confidence limit (p=0.95) and not less than 30 IU as mean value.
³As lower confidence limit (p=0.95).
⁴Or equivalent activity determined by an immunogenicity evaluation.
⁵Cultivated on Vero cells.
⁶These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method.
⁷Produced in yeast Hansenula polymorpha cells by recombinant DNA technology.
The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B.
Excipients/Inactive Ingredients: The other ingredients are: 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.