HAVRIX 1440 VACCINE 1440 ELISA UNITS/ML

GSK BIOLOGICALS, BRANCH OF SMITHKLINE BEECHAM PHARMA GMBH & CO. KG (PRIMARY PACKAGER) - GERMANYGLAXOSMITHKLINE BIOLOGICALS SA (BELGIUM)🇸🇬 Health Sciences Authority

Approval Date: Apr 30, 1996
Approval ID: f8df73afdaf551a9
Company: GSK BIOLOGICALS, BRANCH OF SMITHKLINE BEECHAM PHARMA GMBH & CO. KG (PRIMARY PACKAGER) - GERMANYGLAXOSMITHKLINE BIOLOGICALS SA (BELGIUM)
Type: Therapeutic

Approval Details

Approval Id: f8df73afdaf551a9
Drug Name: HAVRIX 1440 VACCINE 1440 ELISA UNITS/ML
Product Name: HAVRIX 1440 VACCINE 1440 ELISA UNITS/ML
Approval Number: SIN08683P
Approval Date: 1996-04-30
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: INJECTION
Dosage: Dosage and Administration <ul> <li>Posology Primary vaccination <ul class="dash"> <li>Adults from age 19 years and onwards A single dose of Havrix 1440 Adult (1.0 mL suspension) is used for primary immunisation.</li> <li>Children and adolescents from 1 year up to and including 18 years of age A single dose of Havrix 720 Junior (0.5 mL suspension) is used for primary immunisation.</li> </ul> Booster vaccination After primary vaccination with either Havrix 1440 Adult or Havrix 720 Junior, a booster dose is recommended at any time between 6 and 12 months after the primary dose in order to ensure long term protection.</li> </ul> Method of administration Havrix is for intramuscular administration. The vaccine should be injected in the deltoid region in adults and children, in the antero-lateral part of the thigh in young children. The vaccine should not be administered in the gluteal region. The vaccine should not be administered subcutaneously/intradermally since administration by these routes may result in a less than optimal anti-HAV antibody response. Havrix should under no circumstances be administered intravascularly. Havrix should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects. Firm pressure should be applied to the injection site (without rubbing) for at least two minutes.
Route Of Administration: INTRAMUSCULAR
Indication Info: 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 Injectable Drugs. Contacts of Infected Persons. Since virus shedding of infected persons may occur for a prolonged period, active immunisation of close contacts is recommended. Persons who require protection as part of hepatitis A outbreak control or because of regionally elevated morbidity. Specific population groups known to have a higher incidence of hepatitis A. For example American Indians, Eskimos, recognised community-wide HAV epidemics. Subjects with chronic liver disease or who are at risk of developing chronic liver disease (e.g. Hepatitis B (HB) and Hepatitis C (HC) chronic carriers and alcohol abusers). In areas of intermediate to high prevalence of hepatitis A (e.g. Africa, Asia, the Mediterranean basin, the Middle East, Central and South America) susceptible individuals may be considered for active immunisation.
Contraindications: Contraindications Havrix should not be administered to subjects with known hypersensitivity to any component of the vaccine (see Qualitative and quantitative composition and List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), or to subjects having shown signs of hypersensitivity after previous administration of Havrix.
Atc Code: J07BC02
Atc Item Name: hepatitis A, inactivated, whole virus
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD
Company Detail Path: /organization/glaxosmithkline-pte-ltd

Active Ingredients

HEPATITIS A VIRUS (INACTIVATED)

1440 elisa units/ml

HEPATITIS A VIRUS (INACTIVATED)

1440 elisa units/ml

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Apr 30, 1996

Approval ID

f8df73afdaf551a9

Type

Therapeutic

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