Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
Measles virus; Rubella virus; Mumps virus; Varicella vaccine - live
GlaxoSmithKline Australia Pty Ltd
Medicine Registered
1 PRIORIX-TETRA _Measles-Mumps-Rubella-Varicella vaccine (live, attenuated) _ CONSUMER MEDICINE INFORMATION LEAFLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about _PRIORIX-TETRA_ 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 _PRIORIX-TETRA_ against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT _PRIORIX-TETRA_ TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT _PRIORIX-TETRA_ IS USED FOR _PRIORIX-TETRA_ is a vaccine used to prevent four diseases, measles, mumps, rubella (German measles) and varicella (chickenpox). Measles, mumps, rubella and varicella are all infectious diseases caused by viruses. The vaccine works by causing the body to produce its own protection (antibodies) against these diseases. MEASLES Measles is a highly infectious viral illness. Measles is spread by small droplets from the nose, throat or mouth of an infected person (often before it is obvious they have measles). Measles often begins with a fever, runny nose, hacking cough and conjunctivitis (eye inflammation). The rash appears 3-5 days after the onset of symptoms and spreads rapidly all over the body. Measles is often a severe disease complicated by ear infection and pneumonia (lung infection). Encephalitis (swelling of the brain) can also occur and can sometimes result in permanent brain damage or death. Unimmunised children in the following groups are at particular risk from severe measles infection: Läs hela dokumentet
1 PRIORIX-TETRA® PRODUCT INFORMATION Measles, mumps, rubella and varicella vaccine (live, attenuated) NAME OF THE DRUG _PRIORIX-TETRA_ is a live virus vaccine for immunisation against measles, mumps, rubella and varicella. DESCRIPTION _PRIORIX-TETRA_ is a sterile lyophilised mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain), the Wistar RA 27/3 rubella virus strain and the OKA strain of varicella-zoster virus. Each virus strain is separately produced in either chick embryo cells (mumps and measles) or MRC5 human diploid cells (rubella and varicella). _PRIORIX-TETRA_ is presented as a white to slightly pink pellet for reconstitution with sterile Water for Injection diluent. Each 0.5mL dose of the reconstituted vaccine contains not less than 10 3.0 CCID 50 (cell culture infective dose 50%) of the Schwarz measles, not less than 10 4.4 CCID 50 of the RIT 4385 mumps, not less than 10 3.0 CCID 50 of the Wistar RA 27/3 rubella and not less than 10 3.3 plaque-forming units (PFU) of the varicella-zoster OKA virus strains. The four virus strains are mixed prior to lyophilisation. The lyophilised vaccine also contains lactose, neomycin sulfate, amino acids and sorbitol and mannitol as stabilisers. There is no human serum albumin in _PRIORIX-TETRA._ The manufacture of this product includes exposure to bovine derived materials sourced to minimise the risk of prion contamination. 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. _PRIORIX-TETRA_ meets the World Health Organisation requirements for manufacture o Läs hela dokumentet