País: Cingapura
Língua: inglês
Origem: HSA (Health Sciences Authority)
Diphtheria toxoid; Filamentous Hemagglutinin (FHA); Inactivated polio virus type 1; Inactivated polio virus type 2; Inactivated polio virus type 3; Pertactin (PRN); Pertussis toxoid (PT); Tetanus toxoid
GLAXOSMITHKLINE PTE LTD
J07CA02
INJECTION, SUSPENSION
Diphtheria toxoid 2.5 Lf/ 0.5 ml - not less than 2 IU; Filamentous Hemagglutinin (FHA) 8 mcg/0.5ml; Inactivated polio virus type 1 40 DU/0.5 ml; Inactivated polio virus type 2 8 DU/0.5 ml; Inactivated polio virus type 3 32 DU/0.5 ml; Pertactin (PRN) 2.5 mcg/0.5 ml; Pertussis toxoid (PT) 8 mcg/0.5 ml; Tetanus toxoid 5.0 Lf/0.5ml - not less than 20 IU
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals SAS
ACTIVE
2020-02-20
-1- BOOSTRIX POLIO DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) 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 Inactivated poliovirus type 1 (Mahoney strain) 2 40 D-antigen unit type 2 (MEF-1 strain) 2 8 D-antigen unit type 3 (Saukett strain) 2 32 D-antigen unit 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.3 milligrams Al 3+ and aluminium phosphate (AlPO 4 ) 0.2 milligrams Al 3+ 2 propagated in VERO cells Boostrix Polio 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 Polio is indicated for booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis of individuals from the age of three years onwards (see _Posology)_ . The use of Boostrix Polio should be in accordance with official recommendations. DOSAGE AND ADMINISTRATION POSOLOGY A single 0.5 ml dose of the vaccine is recommended. Boostrix Polio may be administered from the age of three years onwards. Boostrix Polio should be administered in accordance with official recommendations and/or local practice -2- regarding the use of vaccines with reduced content of diphtheria toxoid plus tetanus toxoid in combination with pertussis and poliomyelitis antigens. Boostrix Polio can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see _Pregnancy_ and P _harmacodynamics_ ). Boostrix Polio may also be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation Leia o documento completo