Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Influenza virus haemagglutinin
GlaxoSmithKline Australia Pty Ltd
Medicine Registered
1 FLUARIX ® _(Inactivated Split Influenza Vaccine) _ CONSUMER MEDICINE INFORMATION LEAFLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about FLUARIX vaccine. 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 possible risks of you/your child having FLUARIX against the expected benefits. IF YOU HAVE ANY CONCERNS ABOUT RECEIVING FLUARIX TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET WITH THIS VACCINE. You may need to read it again. WHAT FLUARIX IS USED FOR FLUARIX is used to prevent certain types of influenza. The vaccine works by causing the body to produce its own protection (antibodies) against three different types of influenza virus. Each year new types of influenza virus can appear, so every year FLUARIX is changed to contain fragments of the new types of virus. Therefore, influenza vaccination is recommended every year. PLEASE NOTE THAT FLUARIX WILL ONLY PROTECT YOU AGAINST THE THREE TYPES OF INFLUENZA VIRUS USED TO MAKE THE VACCINE. IT WILL NOT PROTECT YOU FROM INFLUENZA CAUSED BY OTHER TYPES OF INFLUENZA VIRUS OR FROM INFECTIONS WITH OTHER AGENTS CAUSING FLU-LIKE SYMPTOMS (SUCH AS THE COMMON COLD). Influenza is an infectious illness. Influenza is spread by small droplets from the nose, throat or mouth of an infected person. Symptoms of influenza begin 48 hours after coming into contact with the virus. These consist of chills, fever, generalised aches and pains, headache and respiratory symptoms (sore throat, runny nose, cough). The severity and type of symptoms can vary. Olvassa el a teljes dokumentumot
1 FLUARIX® PRODUCT INFORMATION (INACTIVATED SPLIT INFLUENZA VACCINE) NAME OF THE MEDICINE Fluarix inactivated split influenza vaccine suspension for injection DESCRIPTION Fluarix is an inactivated and purified split influenza vaccine. The antigen composition and strains for the 2013 influenza season corresponds to the following types: A/California/7/2009 (H1N1)pdm09-like strain used (NIB-74xp) derived from A/Christchurch/16/2010: 15µg haemagglutinin per dose. A/Victoria/361/2011 (H3N2)-derived strain used (IVR-165): 15µg haemagglutinin per dose. B/Wisconsin/1/2010-like strain used (NYMC BX-39) derived from B/Hubei- Wujiagang/158/2009: 15µg haemagglutinin per dose. Fluarix is prepared using whole virus cultivated in embryonated hens' eggs. The virus is concentrated and purified by clarification, adsorption and centrifugation. The purified whole virus is then treated with the detergent sodium deoxycholate and again centrifuged, and the resulting antigen suspension is inactivated with formaldehyde. Each 0.5 ml vaccine dose contains 15 g haemagglutinin of each of the recommended strains (total of 45 µg haemagglutinin). The vaccine preparation also contains alpha tocopheryl acid succinate, sodium deoxycholate, sodium chloride, magnesium chloride, potassium chloride, potassium phosphate monobasic, sodium phosphate dibasic dodecahydrate, sucrose, polysorbate 80, octoxinol 10, formaldehyde and gentamicin sulfate in water for injections. 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) Olvassa el a teljes dokumentumot