Country: Ինդոնեզիա
language: ինդոնեզերեն
source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; INACTIVATED POLIO VIRUS TYPE 1; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 3; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID
AVENTIS PHARMA - Indonesia
DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; INACTIVATED POLIO VIRUS TYPE 1; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 3; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID
CAIRAN INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0.5 ML (1 DOSIS)
SANOFI PASTEUR - France
2017-03-04
TETRAXIM DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED) COMPOSITION One dose (0.5 mL) contains: Diphtheria toxoid (1) ................................................................................................................... ≥ 30 IU (2) (3) Tetanus toxoid (1) ........................................................................................................................ ≥ 40 IU (3) (4) _Bordetella pertussis _antigens: Pertussis toxoid (1) .................................................................................................................. 25 micrograms Filamentous haemagglutinin (1) ...............................................................................................25 micrograms Poliomyelitis virus (inactivated) - type 1 (Mahoney strain) (5) ........................................................................................................... 40 DU (6) (7) - type 2 (MEF-1 strain) (5) ............................................................................................................... 8 DU (6) (7) - type 3 (Saukett strain) (5) ............................................................................................................ 32 DU (6) (7) (1) Adsorbed on aluminium hydroxide, hydrated ......................................................................... 0.3 mg Al 3+ (2) As mean value (3) Or equivalent activity determined by evaluation of immunogenicity (4) As lower confidence limit (p = 0.95) (5) Produced on VERO cells (6) DU: D antigen unit (7) Or equivalent antigenic quantity determined by a suitable immunochemical method TETRAXIM may contain traces of glutaraldehyde, neomycin, streptomycin and polymyxin B. Excipient with known effect: Phenylalanine…………………………………………………………………………12.5 micrograms LIST OF EXCIPIENTS: • Hanks’ medium 199 (without phenol red) • Glacial acetic acid and/or sodium hydroxide (for pH adjustment) • For read_full_document