TETRAXIM

País: Indonesia

Idioma: indonesio

Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredientes activos:

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

Disponible desde:

AVENTIS PHARMA - Indonesia

Designación común internacional (DCI):

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

formulario farmacéutico:

CAIRAN INJEKSI

Unidades en paquete:

DUS, 1 PREFILLED SYRINGE @ 0.5 ML (1 DOSIS)

Fabricado por:

SANOFI PASTEUR - France

Fecha de autorización:

2017-03-04

Ficha técnica

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