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Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).
Hexaxim is a whitish, cloudy suspension.
One dose1 (0.5 ml) contains: Diphtheria Toxoid not less than 20 IU2,4 (30Lf); Tetanus Toxoid not less than 40 IU3,4 (10Lf); Bordetella pertussis antigens: Pertussis Toxoid 25 micrograms, Filamentous Haemagglutinin 25 micrograms; Poliovirus (Inactivated)5: Type 1 (Mahoney) 40 D antigen units6, Type 2 (MEF-1) 8 D antigen units6, Type 3 (Saukett) 32 D antigen units6; Hepatitis B surface antigen7 10 micrograms; Haemophilus influenzae type b polysaccharide 12 micrograms (Polyribosylribitol Phosphate) conjugated to Tetanus protein 22-36 micrograms.
1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al 3+).
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 Produced on Vero cells.
6 Or equivalent antigenic quantity determined by a suitable immunochemical 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, Saccharose, 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.
