Land: Indonesia
Språk: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AGLUTINOGENS 2+3; DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; FIMBRIAE; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID
AVENTIS PHARMA - Indonesia
AGLUTINOGENS 2+3; DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; FIMBRIAE; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID
CAIRAN INJEKSI
DUS, 1 VIAL @ 0,5 ML (1 DOSIS)
SANOFI PASTEUR Limited - Canada
2017-11-20
DISETUJUI OLEH BPOM 4 AGUSTUS 2022 ID REG:EREG10002212000297 ADACEL-CCDS V19-v06-Aug22 ADACEL ® TETANUS TOXOID AND DIPHTHERIA TOXOIDS ADSORBED COMBINED WITH COMPONENT PERTUSSIS VACCINE COMPOSITION Each single dose (0.5 mL) contains: Tetanus Toxoid 5 Lf Diphtheria Toxoid 2 Lf Component Pertussis Pertussis Toxoid 2.5 µg Filamentous Haemagglutinin 5 µg Fimbrial agglutinogens 2 + 3 5 µg Pertactin 3 µg Aluminum Phosphate (aluminum 0.33 mg) 1.5 mg 2-phenoxyethanol 0.6% (v/v) Residual formaldehyde ≤ 5 µg Residual glutaraldehyde ADACEL ® appears as a sterile, uniform, cloudy, white suspension. < 50 µg DESCRIPTION ADACEL ® [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed], is a sterile, uniform, cloudy, white suspension of tetanus and diphtheria toxoids adsorbed separately on aluminum phosphate, combined with acellular pertussis vaccine and suspended in water for injection. The acellular pertussis vaccine is composed of 5 purified pertussis antigens (PT. FHA, PRN and FIM). INDICATIONS ADACEL ® is indicated for active booster immunization for the prevention of tetanus, diphtheria and pertussis (whooping cough) in person 4 to 6 years of age and 10 years or older. ADACEL® is indicated for passive protection against pertussis in early infancy following maternal DISETUJUI OLEH BPOM 4 AGUSTUS 2022 ID REG:EREG10002212000297 ADACEL-CCDS V19-v06-Aug22 immunization during pregnancy (see sections DOSAGE AND ADMINISTRATION, and WARNING AND PRECAUTION). ADACEL® should be used in accordance with official recommendations In accordance with local recommendations, Adacel may be considered as an alternative for the fifth dose of tetanus, diphtheria and acellular pertussis vaccine (DTaP) (Tdap) in children 4 through 6 years of age, concomitantly administered with inactivated Poliomyelitis Vaccine (IPV) at separate site to complete the vaccination series of this age when indicated. ADACEL® is not to be used for the treatment of disease caused by Bordetella pertussis. Corynebacterium diphtheri Les hele dokumentet