Country: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY), INACTIVATED POLIOMYELITIS VIRUS TYPE 2 (MEF STRAIN), INACTIVATED POLIOMYELITIS VIRUS TYPE 3 (SAUKETT STRAIN), HEPATITIS B SUR
AVENTIS PHARMA - Indonesia
DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY), INACTIVATED POLIOMYELITIS VIRUS TYPE 2 (MEF STRAIN), INACTIVATED POLIOMYELITIS VIRUS TYPE 3 (SAUKETT STRAIN), HEPATITIS B SUR
NLT 20 IU /NLT 40 IU /25 MCG /25 MCG /40 DU /8 DU /32 DU /10 MCG /12 MCG
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,5 ML + 2 SEPARATE NEEDLES
SANOFI PASTEUR - France
2020-03-18
1 HEXAXIM SUSPENSION FOR INJECTION DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), HEPATITIS B (RDNA), POLIOMYELITIS (INACTIVATED) AND _HAEMOPHILUS INFLUENZAE _ TYPE B CONJUGATE VACCINE (ADSORBED). COMPOSITION One dose 1 (0.5 ml) contains: Diphtheria Toxoid not less than 20 IU 2 Tetanus Toxoid not less than 40 IU 2,3 _Bordetella pertussis _antigens Pertussis Toxoid 25 micrograms Filamentous Haemagglutinin 25 micrograms Poliovirus (Inactivated) 4 Type 1 (Mahoney) Type 2 (MEF-1) Type 3 (Saukett) Hepatitis B surface antigen 6 _Haemophilus influenzae _type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein 40 D antigen units 5 8 D antigen units 5 32 D antigen units 5 10 micrograms 12 micrograms 22 -36 micrograms 1 Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al 3+ ) 2 As lower confidence limit (p= 0.95) 3 Or equivalent activity determined by an immunogenicity evaluation 4 Produced on Vero cells 5 Or equivalent antigenic quantity determined by a suitable immunochemical method 6 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) LIST OF EXCIPIENTS: 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. THERAPEUTIC INDICATION 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, poliomyelitis and invasive diseases caused by _Haemophilus influenzae _type b (Hib). The use of this vaccine should be in accordance with official recommendations. DISETUJUI OLE Aqra d-dokument sħiħ