Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
live varicella vaccine, Quantity: 4000 PFU/mL; isoleucine, Quantity: 0.355 mg
GlaxoSmithKline Australia Pty Ltd
live varicella vaccine
Injection, powder for
Excipient Ingredients: lactose; mannitol; sorbitol; threonine; serine; proline; glycine; alanine; valine; methionine; leucine; tyrosine; phenylalanine; tryptophan; lysine hydrochloride; histidine; arginine
Subcutaneous
1 x 0.5mL vial plus, 1 x 0.5mL diluent ampoule, 10 x 0.5mL vials plus, 10 x 0.5mL diluent ampoules
(S4) Prescription Only Medicine, Not scheduled. Not considered by committee
VARILRIX HSA-FREE is indicated for active immunisation against varicella of healthy subjects from 9 months of age. Groups who would particularly benefit from vaccination include: Non-immune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children's day-care centres. Non-immune parents of young children. Non-immune household contacts, both adults and children, of immunocompromised patients with no history of the disease.
Visual Identification: Lyophilised - cream to yellowish or pinkish coloured powder in a glass vial; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2015-04-16
VARILRIX ® 1 VARILRIX ® (HUMAN ALBUMIN FREE) _Live attenuated varicella vaccine _ CONSUMER MEDICINE INFORMATION LEAFLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about VARILRIX 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 VARILRIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT VARILRIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. YOU MAY NEED TO READ IT AGAIN WHAT VARILRIX IS USED FOR VARILRIX is a vaccine used in children aged 9 months or older, adolescents and adults to prevent chickenpox. Groups who would benefit mostly from vaccination include: adults not immunised (protected) against chickenpox, especially those in ‘at-risk’ occupations such as health care workers, teachers and workers in child care centres adults not immunised, who are parents of young children adults and children not immunised, who live in the same house with people who have lowered immunity and have no history of chickenpox. The vaccine works by causing the body to produce its own protection (antibodies) against this disease. Chickenpox is caused by a virus called the varicella-zoster virus. VARILRIX vaccine contains a weakened form of the chickenpox (varicella-zoster) virus. Chickenpox is a highly infectious disease, which usually causes an itchy, red rash with blisters. After about 1 week, most of the blisters have normally crusted over. The rash can appear on the face, scalp, body, or in the mouth, eyes and bottom. Other symptoms can include fever, headaches, chills, and muscle and/or joint aches and pains. Sometimes disease complications can occur such as bacterial infection of the skin (often due to itching of the rash/crusts), inflammation of the brain (varicella encephalitis), and lung infection (varicella pneumonia). Com Preberite celoten dokument
1 AUSTRALIAN PRODUCT INFORMATION VARILRIX HUMAN SERUM ALBUMIN-FREE (VARICELLA) VACCINE, (LIVE, ATTENUATED), POWDER AND DILUENT FOR SOLUTION FOR INJECTION. 1 NAME OF THE MEDICINE Live varicella vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VARILRIX is a lyophilised preparation of the live attenuated Oka strain of varicella-zoster virus, obtained by propagation of the virus in MRC 5 human diploid cell culture. Each 0.5 mL dose of the reconstituted vaccine contains not less than 10 3.3 plaque-forming units (PFU) of the varicella-zoster virus. 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. VARILRIX meets the World Health Organisation requirements for biological substances and for varicella vaccines. LIST OF EXCIPIENTS WITH KNOWN EFFECT VARILRIX also contains the excipient ingredient phenylalanine and residual amounts of neomycin sulphate, which is carried over from the manufacturing process. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Powder and diluent for solution for injection. VARILRIX is presented as a slightly cream to yellowish or pinkish coloured powder for reconstitution with clear and colourless sterile diluent. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VARILRIX is indicated for active immunisation against varicella of healthy children and adults from 9 months of age. Groups who would particularly benefit from vaccination include: 2 • Non-immune adults, especially those in at-risk occupations such as health care workers, teachers and workers in children’s day-care centres • Non-immune parents of young children • Non-immune household contacts, both adults and children, of immunocompromised patients with no history of the disease_ _ 4.2 DOSE AND METHOD OF ADMINISTRATION VARILRIX should be administered as a single dose by subcutaneous injecti Preberite celoten dokument