Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN
GLAXO WELLCOME INDONESIA - Indonesia
DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN
2.5 LF /5.0 LF /8 MCG /8 MCG /2.5 MCG
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 0,5 ML (1 DOSIS) + 2 JARUM
GlaxoSmithKline Biologicals SA - Belgium
2021-12-31
FAW_leaBOOinj_Update PI to GDS15 IPI16_circ1_2Nov22 - for submission _Page 1 of 8 _ BOOSTRIX DIPHTHERIA, TETANUS AND PERTUSSIS (ACELLULAR, COMPONENT) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT) SUSPENSION FOR INJECTION QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 mL) contains: Diphtheria toxoid 1 not less than 2 International Units (IU) (2.5 Lf) Tetanus toxoid 1 not less than 20 International Units (IU) (5 Lf) _Bordetella pertussis_ antigens Pertussis toxoid 1 8 micrograms Filamentous haemagglutinin 1 8 micrograms Pertactin 1 2.5 micrograms 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ _BOOSTRIX_ is a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. This is a normal finding. CLINICAL INFORMATION INDICATIONS_ _ _BOOSTRIX_ is indicated for booster vaccination against diphtheria, tetanus and pertussis of individuals from the age of four years onwards (see _Posology_). _BOOSTRIX_ is also indicated for passive protection against pertussis in early infancy following maternal immunization during pregnancy (see _Posology, Pregnancy _and_ Pharmacodynamics_). The use of _BOOSTRIX_ should be in accordance with official recommendations. DOSAGE AND ADMINISTRATION Posology A single 0.5 mL dose of the vaccine is recommended. _ _ _BOOSTRIX_ can be given in accordance with the current local medical practices for booster vaccination with reduced-content combined diphtheria-tetanus vaccine, when a booster against pertussis is desired. _BOOSTRIX_ can be administered to pregnant women between 27 and 36 weeks of pregnancy in accordance with official recommendations (see _Indications, Pregnancy _and_ Pharmacodynamics_)_._ _BOOSTRIX_ may also be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunization series against diphtheria, tetanus and pertussis (see section _Pharmacodynamics_). Based o Lees het volledige document