Pajjiż: Singapor
Lingwa: Ingliż
Sors: HSA (Health Sciences Authority)
HEPATITIS A VIRUS INACTIVATED
GLAXOSMITHKLINE PTE LTD
J07BC02
720 elisa units/0.5ml
INJECTION
HEPATITIS A VIRUS INACTIVATED 720 elisa units/0.5ml
INTRAMUSCULAR
Prescription Only
GSK Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG (primary packager)
ACTIVE
1998-05-04
1 Proposed Package Insert (updated 1Jun12) HAVRIX™ 1440 ADULT / 720 JUNIOR INACTIVATED HEPATITIS A VACCINE QUALITATIVE AND QUANTITATIVE COMPOSITION Suspension for injection. 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. PHARMACEUTICAL FORM Suspension for injection. CLINICAL PARTICULARS INDICATIONS HAVRIX™ is indicated for active immunisation 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, immunisation 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 immunisation 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 Aqra d-dokument sħiħ
1 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. CLINICAL INFORMATION INDICATIONS HAVRIX is indicated for active immunisation 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, immunisation 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 immunisation 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, among others. Persons at increased risk due to their sexual behaviour. Homosexuals,_ _persons with multiple sexual partners. Haemophiliacs. Abusers of Injecta Aqra d-dokument sħiħ