Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
Measles virus, Quantity: 1000 CCID50; Rubella virus, Quantity: 1000 CCID50; Mumps virus, Quantity: 25119 CCID50; live varicella vaccine, Quantity: 1995 PFU
GlaxoSmithKline Australia Pty Ltd
live varicella vaccine,Measles virus,Mumps virus,Rubella virus
Diluent, not applicable
Excipient Ingredients: water for injections
Intramuscular, Subcutaneous
1 vial of active and 1 Diluent ampoule, 10 vials of active and 10 Diluent ampoules
(S4) Prescription Only Medicine
Priorix-Tetra is indicated for active immunisation against measles, mumps, rubella and varicella from 9 months of age.
Visual Identification: ; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
PRIORIX-TETRA 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: • children with chronic conditions such as cystic fibrosis, congenital heart or kidney disease, failure to thrive, Down's Syndrome • children from the age of 1 year upwards in child care centres, family day care and playgroups • children living in institutions • Aboriginal and Torres Strait Islander children. _MU Lire le document complet
1 AUSTRALIAN PRODUCT INFORMATION PRIORIX TETRA (MEASLES, MUMPS, RUBELLA AND VARICELLA) VACCINE, (LIVE, ATTENUATED), POWDER AND DILUENT FOR SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Measles virus, mumps virus, rubella virus and live varicella vaccine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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). Each 0.5 mL 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 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 of biological substances and for measles, mumps, rubella and varicella vaccines and combined vaccines (live). LIST OF EXCIPIENTS WITH KNOWN EFFECT PRIORIX-TETRA 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. PRIORIX-TETRA is presented as a whitish to slightly pink powder for reconstitution with clear and Lire le document complet