Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Hepatitis a virus antigen, Quantity: 1440 ELISA unit
GlaxoSmithKline Australia Pty Ltd
Hepatitis a virus antigen
Injection, suspension
Excipient Ingredients: polysorbate 20; dibasic sodium phosphate heptahydrate; monobasic potassium phosphate; sodium chloride; potassium chloride; water for injections; aluminium hydroxide hydrate; acetic acid; leucine; phenylalanine; methionine; lysine hydrochloride; isoleucine; valine; histidine; threonine; tryptophan; alanine; arginine; proline; tyrosine; serine; sodium acetate; dibasic potassium phosphate; magnesium chloride hexahydrate; glycine
Intramuscular
1 x 1mL syringe
(S4) Prescription Only Medicine
HAVRIX is indicated for active immunisation against hepatitis A virus (HAV) infection in susceptible subjects at risk of exposure to HAV. HAVRIX JUNIOR is indicated in subjects aged 2 to 15 years and HAVRIX 1440 is indicated in subjects aged 16 years and older. In areas of low prevalence of hepatitis A, immunisation with HAVRIX is particularly recommended in the following subjects: Travellers : Persons travelling to areas of intermediate or high endemicity for hepatitis A. These areas include Africa, Asia, India, the Pacific Islands, 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. 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 particularly in situations where children have not been toilet trained; teachers and other close contacts of the intellectually disabled; staff and residents of residential facilities for the intellectually disabled; health workers and teachers in remote Aboriginal and Torres Strait Islander communities; nursing staff and other healthcare workers in contact with patients in paediatric wards, infectious diseases wards, emergency rooms and intensive care units sewerage workers ; food handlers, since food hygiene procedures and food processing methods are not always adequate to protect from contamination from food handlers. Homosexual men : Increased incidence of hepatitis A infection among homosexual males suggests that the disease may be sexually transmitted in this group. Contacts of infected persons : Since virus shedding from infected persons may occur for a prolonged period, active immunisation of close contacts is recommended. The use of vaccine in outbreak control has been shown to be more effective than the use of immunoglobulin. Specific population groups known to have a higher incidence of hepatitis A: eg. Australian aboriginals, recognised community-wide HAV epidemics. Individuals with chronic liver disease and recipients of liver transplants, as hepatitis A infections is likely to be more severe in these groups. Many injecting drug users will have pre-existing liver disease from hepatitis B or hepatitis C infection. Recipients of blood products, such as Factor VIII eg. haemophiliacs. HAVRIX will not prevent hepatitis infection caused by other agents such as hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E or other pathogens known to infect the liver.
Visual Identification: A turbid liquid with a slow settling white deposit; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2008-04-22
1 HAVRIX 1440 AND HAVRIXJUNIOR _Inactivated Hepatitis A Virus Vaccine _ CONSUMER MEDICINE INFORMATION LEAFLET In this leaflet, HAVRIX refers to the use of both HAVRIX 1440 for adults, and HAVRIX Junior for children. WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about HAVRIX vaccine. It does not contain all the available information. It does not take the place of talking to your doctor, nurse or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the possible risks of you or your child having HAVRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT HAVRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT IS HAVRIX USED FOR HAVRIX is a vaccine used to prevent hepatitis A infection. The vaccine works by causing the body to produce its own protection (antibodies) against this disease. Hepatitis A is an infectious disease, which can affect the liver. This disease is caused by the hepatitis A virus. The hepatitis A virus can be passed from person to person in food and drink, or by swimming in water contaminated by sewage. Symptoms of hepatitis A begin 3 to 6 weeks after coming into contact with the virus. These consist of nausea (feeling sick), fever and aches and pains. After a few days the whites of eyes and skin may become yellowish (jaundice). The severity and type of symptoms can vary. Young children may not develop jaundice. Most people recover completely but the illness is usually severe enough to keep people off work for about a month. Hepatitis A is very common in many parts of the world, and the risk of infection is greatest in those areas where hygiene and sanitation are poor. Such areas include Asia, India, Africa, Central and South America, the Pacific Islands, the Middle East, and the Mediterranean basin. HAVRIX is recommended for all travellers to these areas, including people in the armed forces. Hepatitis A occurs in Australia, but is not common. Some groups of pe Læs hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION HAVRIX 1440 AND HAVRIX JUNIOR (INACTIVATED HEPATITIS A VIRUS VACCINE) SUSPENSION FOR INJECTION 1 NAME OF THE MEDICINE Inactivated Hepatitis A virus vaccine_ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION HAVRIX, hepatitis A vaccine, is a sterile suspension containing formaldehyde - inactivated hepatitis A virus (HM 175 hepatitis A virus strain) adsorbed onto aluminium hydroxide hydrate. The virus is propagated in MRC5 human diploid cells. Before viral extraction, the cells are extensively washed to remove culture medium constituents. A virus suspension is then obtained by lysis of the cells followed by purification using ultrafiltration techniques and gel chromatography. The virus is then inactivated with formalin. Residual formaldehyde in the vaccine should be not more than 0.01%. 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 hydrate Total: 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 hydrate Total : 0.25 milligrams Al 3+ The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. HAVRIX meets the World Health Organization requirements for biological substances. LIST OF EXCIPIENTS WITH KNOWN EFFECT For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 2 3 PHARMACEUTICAL FORM Suspension for injection. Turbid liquid suspension. Upon storage, a fine white deposit with a clear colourless supernatant can be observed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HAVRIX is indicated for active immunisation against hepatitis A virus (HAV) infection in susceptible subjects at risk of exposure to HAV. H Læs hele dokumentet