Страна: Индонезия
Език: индонезийски
Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; HEPATITIS B SURFACE ANTIGEN (HBS AG); INACTIVATED POLIO VIRUS TYPE 1; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 3; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID
SMITH KLINE BEECHAM PHARMACEUTICAL IND. - Indonesia
DIPHTERIA TOXOID PROTEIN; FHA; FILAMENTOUS HEMAGGLUTININ; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; HEPATITIS B SURFACE ANTIGEN (HBS AG); INACTIVATED POLIO VIRUS TYPE 1; INACTIVATED POLIO VIRUS TYPE 2; INACTIVATED POLIO VIRUS TYPE 3; PERTACTIN; PERTUSSISTOXOID MED ALUMINIUMHYDROXID; TETANUS TOXOID
CAIRAN INJEKSI
DUS, 1 PRE-FILLED SYRINGE @ 0,5 ML + 1 VIAL @ 0,5 ML
GLAXO SMITHKLINE BIOLOGICALS-Belgium
2018-01-23
_Page 1 of 10_ INFANRIX HEXA ™ COMBINED DIPHTHERIA-TETANUS-ACELLULAR PERTUSSIS, HEPATITIS B, ENHANCED INACTIVATED POLIO VACCINE AND _HAEMOPHILUS INFLUENZAE_ TYPE B VACCINE 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 1 25 micrograms Filamentous Haemagglutinin 1 25 micrograms Pertactin 1 8 micrograms Hepatitis B surface antigen 2,3 10 micrograms Poliovirus (inactivated) 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) 3 conjugated to tetanus toxoid as carrier protein 20 - 40 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. The Hib component is presented as a white powder. For excipients, see _List of Excipients_. PHARMACEUTICAL FORM Powder and suspension for suspension for injection. CLINICAL PARTICULARS INDICATIONS _INFANRIX HEXA_ _™_ is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and _Haemophilus influenzae_ type b. DOSAGE AND ADMINISTRATION POSOLOGY The primary vaccination schedule consists of two or three doses (of 0.5 mL) which should be administered according to official recommendations (see _Pharmacodynamic Effects_ for schedules evaluated in clinical trials). _ INFANRIX HEXA_ _™_ can be considered for the booster if the antigen composition is in accordance with the official recommendations. PRI Прочетете целия документ