Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Hepatitis A virus, Quantity: 50 U/mL
Merck Sharp & Dohme (Australia) Pty Ltd
Hepatitis a virus antigen
Injection
Excipient Ingredients: borax; water for injections; sodium chloride; aluminium
Intramuscular, Subcutaneous
1mL
(S4) Prescription Only Medicine
VAQTA is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus in persons 12 months of age and older. Primary immunisation should be given at least 2 weeks prior to expected exposure to Hepatitis A virus. Individuals who are or will be increased risk of infection include: Travellers to areas of intermediate or high endemicity for hepatitis A. Persons for whom Hepatitis A is an occupational hazard. Employee of child day-care centers. Certain institutional workers (eg. caretakers for the intellectually disabled). Health workers and teachers in remote Aboriginal and Torres Strait Islander communities. Nursing staff and other health care workers in contact with patients in paediatric wards and infectious disease wards. Sewerage workers. Recipients of blood products. Individuals with chronic liver disease and those who have had a liver transplant. Homosexually active males. Human Immunodeficiency Virus (HIV)-infected Adults.
Visual Identification: Slightly opaque white suspension.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1997-01-08
VAQTA ® _Hepatitis A vaccine, Inactivated (hepatitis A virus, inactivated)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VAQTA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given VAQTA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS VACCINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT VAQTA IS USED FOR VAQTA is a vaccine used to help prevent hepatitis A. It can be given to children 12 months of age and older, teenagers and adults. Hepatitis A is an infection of the liver caused by the hepatitis A virus. It can be caught by coming into contact with an infected person who has poor sanitary habits, eating or drinking foods prepared by an infected food handler, or, while uncommon, by blood transfusion from an infected donor. Other circumstances that can increase the risk of infection include: • travelling to areas where hepatitis A is common • living in a community with one or more recorded outbreaks within the last five years • being around groups of other children, for example, daycare centres • living in the same house as someone who is infected • having chronic liver disease or having had a liver transplant • sexual contact with someone who is infected • being infected with Human Immunodeficiency Virus (HIV) • working in the healthcare field • eating raw shellfish • sharing needles for injecting drugs • having a blood disorder requiring transfusion of blood products. Symptoms of hepatitis A usually begin 2 to 8 weeks after coming into contact with the virus. These include loss of appetite, feeling sick (nausea), vomiting, fever, chills, tiredness, yellowing of the skin and/or eyes and dark urine. Most people recover completely from hepatitis A disease. However, occasio Lugege kogu dokumenti
VAQ-I- 122010S Page 1 of 17 AUSTRALIAN PRODUCT INFORMATION VAQTA ® HEPATITIS A VACCINE, INACTIVATED (HEPATITIS A VIRUS, INACTIVATED) 1 NAME OF THE MEDICINE hepatitis A virus, inactivated 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VAQTA ® (Hepatitis A Vaccine, Inactivated) is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts and has been shown to induce antibody to hepatitis A virus protein. It contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, purified by a combination of physical and high performance liquid chromatographic techniques, formalin inactivated, and then adsorbed onto amorphous aluminium hydroxyphosphate sulfate adjuvant. One millilitre of the vaccine contains approximately 50 units (U) of hepatitis A antigen, which is highly purified and is formulated without a preservative. Within the limits of current assay variability, the 50 U dose of VAQTA contains less than 0.1 µg of non-viral protein, less than 4 x 10 -6 µg of DNA, less than 10 -4 µg of bovine albumin and less than 0.8 µg of formaldehyde. Other process chemical residuals (including neomycin) are less than 10 parts per billion (ppb). The manufacture of this product includes exposure to bovine related 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. VAQTA is supplied in two formulations: PAEDIATRIC/ADOLESCENT FORMULATION: Each 0.5 mL dose contains approximately 25 U of hepatitis A virus protein as the active ingredient. ADULT FORMULATION: Each 1 mL dose contains approximately 50 U of hepatitis A virus protein as the active ingredient. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM VAQTA is a Suspension for Injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VAQTA is indicated for Lugege kogu dokumenti