Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
INACTIVATED HEPATITIS A VIRUS
GLAXO WELLCOME INDONESIA - Indonesia
INACTIVATED HEPATITIS A VIRUS
1440 ELISA UNIT
SUSPENSI INJEKSI
DUS, 1 PREFILLED SYRINGE @ 1 DOSIS (1 ML)
GlaxoSmithKline Biologicals SA - Belgium
2021-12-23
FAW_ leaHAVpfs_OnePFS+newGSK logo_circ1_21Nov22 – for submission _Page 1 of 6 _ HAVRIX 1440 ADULT / 720 JUNIOR INACTIVATED HEPATITIS A VACCINE Suspension for injection QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1.0 mL) of _HAVRIX_ 1440 ADULT contains: Hepatitis A virus (inactivated) 1,2 1440 ELISA Units 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated 0.50 milligrams Al 3+ One dose (0.5 mL) of _HAVRIX_ 720 JUNIOR contains: Hepatitis A virus (inactivated) 1,2 720 ELISA Units 1 Produced on human diploid (MRC-5) cells 2 Adsorbed on aluminium hydroxide, hydrated 0.25 milligrams Al 3+ Turbid liquid suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed. Pada proses pembuatannya bersinggungan dengan bahan bersumber babi CLINICAL INFORMATION INDICATIONS _HAVRIX_ is indicated for active immunization against hepatitis A virus (HAV) infection in subjects at risk of exposure to HAV. _HAVRIX_ will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis E virus or other pathogens known to infect the liver. In areas of low to intermediate prevalence of hepatitis A, immunization with _ HAVRIX_ is particularly recommended in subjects who are, or will be, at increased risk of infection such as: Travellers. Persons travelling to areas where the prevalence of hepatitis A is high. These areas include Africa, Asia, the Mediterranean basin, the Middle East, Central and South America. Armed Forces. Armed Forces personnel who travel to higher endemicity areas or to areas where hygiene is poor have an increased risk of HAV infection. Active immunization is indicated for these individuals. Persons for Whom Hepatitis A Is an Occupational Hazard or for Whom There Is an Increased Risk of Transmission. These include employees in day-care centres, nursing, medical and paramedical personnel in hospitals and institutions, especially gastroenterology and paediatric units, sewage workers, food handlers, Lesen Sie das vollständige Dokument