国: インドネシア
言語: インドネシア語
ソース: 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 完全なドキュメントを読む