Hexaxim Description

Hexaxim is a whitish, cloudy suspension.
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
One dose¹ (0.5 mL) contains: 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.
¹ Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al³⁺).
² As lower confidence limit (p=0.95) and not less than 30 IU as mean value.
³ As lower confidence limit (p=0.95).
⁴ Or equivalent activity determined by an immunogenicity evaluation.
⁵ Cultivated on Vero cells.
⁶ These D-antigen quantities expressed by using parallel line method 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 (sigmoid method).
⁷ 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, Sucrose, Essential amino acids including L-phenylalanine, Sodium hydroxide, acetic acid or hydrochloric acid (for pH adjustment), Water for injections.
For adsorbent: see as previously mentioned.