Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
DIPHTHERIA TOXOID (D); FILAMENTOUS HAEMAGGLUTININ (FHA); HIB PURIFIED CAPSULAR POLYSACCHARIDE; PERTACTIN (PRN or 69kDa Outer Membrane Protein); PERTUSSIS TOXOID (PT); POLIO VIRUS TYPE 1 (INACTIVATED); POLIO VIRUS TYPE 2 (INACTIVATED); POLIO VIRUS TYPE 3 (INACTIVATED); TETANUS TOXOID (T)
GLAXOSMITHKLINE PTE LTD
J07CA06
min 30IU/0.5ml
INJECTION
DIPHTHERIA TOXOID (D) min 30IU/0.5ml; FILAMENTOUS HAEMAGGLUTININ (FHA) 25mcg/0.5ml; HIB PURIFIED CAPSULAR POLYSACCHARIDE 10 mcg/0.5 ml; PERTACTIN (PRN or 69kDa Outer Membrane Protein) 8mcg/0.5ml; PERTUSSIS TOXOID (PT) 25mcg/0.5ml; POLIO VIRUS TYPE 1 (INACTIVATED) 40DU/0.5ml; POLIO VIRUS TYPE 2 (INACTIVATED) 8DU/0.5ml; POLIO VIRUS TYPE 3 (INACTIVATED) 32DU/0.5ml; TETANUS TOXOID (T) min 40IU/0.5ml
INTRAMUSCULAR
Prescription Only
GlaxoSmithKline Biologicals
ACTIVE
1999-06-25
1 INFANRIX™-IPV+HIB COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, INACTIVATED POLIO AND _HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 International Units (IU) (25 Lf) Tetanus toxoid 1 not less than 40 International Units (IU) (10 Lf) _Bordetella pertussis_ antigens Pertussis toxoid 1 25 micrograms Filamentous haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Poliovirus (inactivated) 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 _Haemophilus influenzae_ type b purified capsular polysaccharide 3 (polyribosylribitol phosphate) 10 micrograms conjugated to tetanus toxoid as carrier protein approximately 30 micrograms 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.5 milligrams Al 3+ 2 propagated in VERO cells, purified and inactivated with formaldehyde 3 prepared from _Haemophilus influenzae _type b, strain 20,752; after purification, the conjugate is lyophilised in the presence of lactose as stabiliser. The diphtheria and tetanus toxoids obtained from cultures of _Corynebacterium diphtheriae_ and_ Clostridium tetani_ are inactivated and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I _Bordetella pertussis_ from which the PT, FHA and pertactin are extracted, purified and treated with formaldehyde; PT is irreversibly inactivated. The DTPa-IPV component of the vaccine is a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. The Hib component of the vaccine is a white powder. PHARMACEUTICAL FORM Powder and suspension for suspension for injection. 2 CLINICAL PARTICULARS INDICATIONS _INFANRIX_ _™_ _-IPV+HIB_ is indicated for active immunisation in infants Les hele dokumentet
1 INFANRIX-IPV+HIB COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, INACTIVATED POLIO AND _HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Diphtheria toxoid 1 not less than 30 International Units (IU) (25 Lf) Tetanus toxoid 1 not less than 40 International Units (IU) (10 Lf) _Bordetella pertussis_ antigens Pertussis toxoid (PT) 1 25 micrograms Filamentous haemagglutinin (FHA) 1 25 micrograms Pertactin (PRN) 1 8 micrograms Poliovirus (inactivated) (IPV) 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 _Haemophilus influenzae_ type b purified capsular polysaccharide 3 (polyribosylribitol phosphate) (PRP) 10 micrograms conjugated to tetanus toxoid as carrier protein approximately 25 micrograms 1 adsorbed on aluminium hydroxide, hydrated (Al(OH) 3 ) 0.5 milligrams Al 3+ 2 propagated in VERO cells, purified and inactivated with formaldehyde 3 prepared from _Haemophilus influenzae _type b, strain 20,752; after purification, the conjugate is lyophilised in the presence of lactose as stabiliser. The diphtheria and tetanus toxoids obtained from cultures of _Corynebacterium diphtheriae_ and_ Clostridium tetani_ are inactivated and purified. The acellular pertussis vaccine components (PT, FHA and pertactin) are prepared by growing phase I _Bordetella pertussis_ from which the PT, FHA and pertactin are extracted, purified and treated with formaldehyde; PT is irreversibly inactivated. The Infanrix-IPV component of the vaccine is a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. The Hib component of the vaccine is a white powder. CLINICAL INFORMATION INDICATIONS _INFANRIX-IPV+HIB_ is indicated for active immunisation in infants from the age of 2 months against diphtheria, tetanus, pertussis, poliomyelitis and _Haemophilus influenzae_ type b. _INFANRIX-IPV+HIB_ is also indica Les hele dokumentet