Kraj: Indonezja
Język: indonezyjski
Źródło: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INACTIVATED HEPATITIS A VIRUS, HEPATITIS B SURFACE ANTIGEN
GLAXO WELLCOME INDONESIA - Indonesia
INACTIVATED HEPATITIS A VIRUS, HEPATITIS B SURFACE ANTIGEN
720 ELISA UNIT /20 Mcg
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 1 ML (1 DOSIS)
GlaxoSmithKline Biologicals SA - Belgium
2021-12-23
FAW_leaTWIinj_one PFS_circ1_10Nov22 – for submission _Page 1 of 7 _ _ _ TWINRIX INACTIVATED HEPATITIS A AND RDNA HEPATITIS B VACCINE (ADSORBED) QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. One dose (1.0 mL) contains: Hepatitis A virus (inactivated) 1,2 720 ELISA Units Hepatitis B surface antigen 3,4 20 micrograms 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated 0.05 milligrams Al 3+ 3 Produced in yeast cells (_Saccharomyces cerevisiae_) by recombinant DNA technology 4 Adsorbed on aluminium phosphate 0.4 milligrams Al 3+ _TWINRIX_ is a white, slightly milky liquid presented in a glass prefilled syringe. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS INDICATIONS _TWINRIX_ is indicated for use in non immune adults, adolescents and children aged from 2-15 years, who are at risk of both hepatitis A and hepatitis B infection and never been vaccinated or incomplete vaccinated course of hepatitis B. DOSAGE AND ADMINISTRATION DOSAGE A dose of 1.0 mL _TWINRIX_ is recommended for adults, adolescents and children aged from 2-15 years. _Primary vaccination schedules _ • _Adults and adolescents of 16 years of age and above_ The standard primary course of vaccination with _ TWINRIX_ consists of three doses, the first administered at the elected date, the second one month later and the third six months after the first dose. In exceptional circumstances in adults, when travel is anticipated within one month or more after initiating the vaccination course, but where insufficient time is available to allow the standard 0, 1, 6 month schedule to be completed, a schedule of three intramuscular injections given at 0, 7 and 21 days may be used. When this schedule is applied, a fourth dose is recommended 12 months after the first dose. • _Children of 2 to 15 years of age_ The standard primary course of vaccination with _ TWINRIX_ consists of two doses, the first is administered at the elected date and the second between six and twelve months after the f Przeczytaj cały dokument