Țară: Australia
Limbă: engleză
Sursă: Department of Health (Therapeutic Goods Administration)
live varicella vaccine, Quantity: 2700 PFU/mL
Merck Sharp & Dohme (Australia) Pty Ltd
live varicella vaccine,water for injections
Injection, powder for
Excipient Ingredients: monobasic potassium phosphate; potassium chloride; hydrolysed gelatin; sodium chloride; dibasic sodium phosphate; urea; sucrose; monosodium glutamate monohydrate
Subcutaneous
0.5mL Single dose vial and prefilled syringe x 1, 0.5mL Single dose vial and prefilled syringex 10
(S4) Prescription Only Medicine
VARIVAX Refrigerated is indicated for vaccination against varicella in healthy individuals 12 months of age and older.,See the Australian Immunisation Handbook for vaccination recommendations and schedule.,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 disease.
Visual Identification: WHITE CRYSTALLINE PELLET, LYOPHILISED PLUG.; Container Type: Multiple containers; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2005-03-16
VARIVAX ® REFRIGERATED _Varicella virus vaccine live (live varicella vaccine)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about VARIVAX Refrigerated. 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 VARIVAX Refrigerated 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 VARIVAX REFRIGERATED IS USED FOR VARIVAX Refrigerated is a vaccine used to help prevent chickenpox (varicella). It can be given to children 12 months of age and older, teenagers and adults who are healthy. Chickenpox is an infectious disease caused by the varicella-zoster virus, or otherwise known as varicella virus. It occurs in millions of people around the world each year, most often in children 5 to 9 years of age. Chickenpox is easily passed from one person to another. It is commonly spread from person to person through the air by sneezing or coughing. Once a person is infected, it usually takes about 2 to 3 weeks before symptoms of the infection start. Symptoms of chickenpox include mild headache, moderate fever and general discomfort. These are followed by a rash of itchy, little red spots which usually start on the chest, stomach or back, but can appear anywhere on the body. There may be only a few spots or groups of spots, or even hundreds of spots that develop over the next 3 to 5 days. The spots will change into clear blisters filled with fluid which then become cloudy, break open, dry, scab and heal, usually within 5 to 20 days. Although chickenpox is generally a fairly harmless infection, it may be associated with serious complications and/or rarely death. In children, the most common complications are bacterial skin infections. Less frequent but very serious compl Citiți documentul complet
WPC-V210-I-ref-122019 1 AUSTRALIAN PRODUCT INFORMATION – VARIVAX ® REFRIGERATED VARICELLA VIRUS VACCINE LIVE (LIVE VARICELLA VACCINE) 1 NAME OF THE MEDICINE live varicella vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AND 3 PHARMACEUTICAL FORM VARIVAX Refrigerated [Varicella Virus Vaccine Live (Oka/Merck)] is a lyophilised preparation of the Oka/Merck strain of live, attenuated varicella virus. The virus was initially obtained from a child with wild-type varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38). Further passage of the virus for varicella vaccine was performed at MSD Research Laboratories in human diploid cell cultures (MRC-5) that were free of adventitious agents. VARIVAX Refrigerated, when reconstituted as directed, is a sterile preparation for subcutaneous administration. Each 0.5 mL dose contains: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 150 minutes (2 ½ hours). Powder for Injection VARIVAX Refrigerated when reconstituted is a clear, colourless to pale yellow liquid. List of excipients with known effect: This vaccine may contain trace quantities of neomycin. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. The product also contains residual components of MRC-5 cells and trace quantities of neomycin, and bovine serum from MRC-5 culture media. The product contains no preservative. The manufacture of this product includes exposure to bovine derived material. 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. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VARIVAX Refrigerated is indicated for vaccination against varicella in healthy individuals 12 months of age and older. See the Australian Immunisation Handbook for vaccination Citiți documentul complet