País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN, HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID, HEPATITIS B SURFACE ANTIGEN, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY STRAIN), INA
GLAXO WELLCOME INDONESIA - Indonesia
DIPHTERIA TOXOID, TETANUS TOXOID, PERTUSSIS TOXOID, FILAMENTOUS HAEMAGGLUTININ, PERTACTIN, HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID, HEPATITIS B SURFACE ANTIGEN, INACTIVATED POLIOMYELITIS VIRUS TYPE 1 (MAHONEY STRAIN), INA
NOT LESS THAN 30 IU /NOT LESS THAN 40 IU /25 MCG /25 MCG /8 MCG /10 PRP AND ~ 25 T MCG /10 MCG /40
SERBUK DAN SUSPENSI INJEKSI
DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML + 1 VIAL @ 0,5 ML
GlaxoSmithKline Biologicals SA - Belgium
2021-12-23
FAW_leaINFHEXinj_ PI update GDS22 IPI17 (One PFS)_circ1_14Nov22 – for submission _Page 1 of 10_ INFANRIX HEXA DIPHTHERIA (D), TETANUS (T), PERTUSSIS (ACELLULAR, COMPONENT) (PA), HEPATITIS B (RDNA) (HBV), POLIOMYELITIS (INACTIVATED) (IPV) AND _HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE (ADSORBED) 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) Tetanus toxoid 1 not less than 40 International Units (IU) _Bordetella pertussis_ antigens Pertussis toxoid (PT) 1 25 micrograms Filamentous Haemagglutinin (FHA) 1 25 micrograms Pertactin (PRN) 1 8 micrograms Hepatitis B surface antigen (HBs) 2,3 10 micrograms Poliovirus (inactivated) (IPV) type 1 (Mahoney strain) 4 40 D-antigen unit type 2 (MEF-1 strain) 4 8 D-antigen unit type 3 (Saukett strain) 4 32 D-antigen unit _Haemophilus influenzae_ type b polysaccharide 10 micrograms (polyribosylribitol phosphate, PRP) 3 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 produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant DNA technology 3 adsorbed on aluminium phosphate (AlPO 4 ) 0.32 milligrams Al 3+ 4 propagated in VERO cells The DTPa-HBV-IPV component is presented as a turbid white suspension. Upon storage, a white deposit and clear supernatant can be observed. This is a normal observation. The Hib component is presented as a white powder. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS _INFANRIX HEXA_ is indicated for primary vaccination of infants and booster vaccination of toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and _Haemophilus influenzae_ type b. The use of _INFANRIX HEXA_ should be in accordance with official recommendations. DOSAGE AND ADMINISTRATION POSOLOGY The primary vaccination schedule consists of two or three doses (of 0.5 mL) which sho Leer el documento completo