Država: Singapur
Jezik: engleski
Izvor: HSA (Health Sciences Authority)
DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ; HAEMOPHILUS INFLUENZA TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) CONJUGATED TO 22 - 36 μg TETANUS PROTEIN (PRP-T); HEPATITIS B SURFACE ANTIGEN; PERTUSSIS TOXOID; POLIOVIRIUS (INACTIVATED) TYPE 1 (MAHONEY); POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1); POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT); TETANUS TOXOID
SANOFI-AVENTIS SINGAPORE PTE. LTD.
J07CA09
INJECTION, SUSPENSION
DIPHTHERIA TOXOID 30 Lf (>= 20 IU)/0.5 mL; FILAMENTOUS HAEMAGGLUTININ 25 μg/0.5 mL; HAEMOPHILUS INFLUENZA TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) CONJUGATED TO 22 - 36 μg TETANUS PROTEIN (PRP-T) 12 μg/0.5 mL; HEPATITIS B SURFACE ANTIGEN 10 μg/0.5 mL; PERTUSSIS TOXOID 25 μg/0.5 mL; POLIOVIRIUS (INACTIVATED) TYPE 1 (MAHONEY) 40 DU/0.5 mL; POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1) 8 DU/0.5 mL; POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT) 32 DU/0.5 mL; TETANUS TOXOID 10 Lf (>= 40 IU)/0.5 mL
INTRAMUSCULAR
Prescription Only
Sanofi Pasteur Val de Reuil
ACTIVE
2015-08-25
SG/HEX/0823/SmPC0922 NAME OF THE MEDICINAL PRODUCT Hexaxim suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and _Haemophilus influenzae _ type b conjugate vaccine (adsorbed). QUALITATIVE AND QUANTITATIVE COMPOSITION One dose 1 (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) 40 D antigen units 6 Type 2 (MEF-1) 8 D antigen units 6 Type 3 (Saukett) 32 D antigen units 6 Hepatitis B surface antigen 7 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 section Contraindications). Excipient with known effect Phenylalanine ..................... 85 micrograms (See section Special warnings and precautions for use) For the full list of excipients, see section List of excipients. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. Hexaxim is a whitish, cloudy suspension. CLINICAL PARTICULARS SG/HEX/0823/SmPC0922 THERAPEUTIC INDICATIONS Hexaxim (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomy Pročitajte cijeli dokument