VAXIGRIPJuniorPI2007Season 流感疫苗 英文说明书.pdf

® VAXIGRIP JUNIOR INACTIVATED INFLUENZA VACCINE (SPLIT VIRION) BP PRODUCT INFORMATION COMPOSITION Inactivated Influenza Vaccine (Split Virion) BP DESCRIPTION A purified, inactivated, split vaccine, each 0.25 mL of which contains antigens representative of the following types: A/New Caledonia/20/99 (H1N1)-like strain (A/New Caledonia /20/99 IVR-116) 7.5ug haemagglutinin, A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005 NYMCX-161B) 7.5 µg haemagglutinin and B/Malaysia/2506/2004 - like strain 7.5 µg haemagglutinin, in an aqueous suspension. An aqueous suspension is a buffered saline solution composed of: 2 mg sodium chloride, 50 µg potassium chloride, 287.5 µg sodium phosphate – dibasic dihydrate, 50 µg potassium phosphate – monobasic and water for injection to 0.25 mL. The vaccine is prepared from virus grown in the allantoic cavity of embryonated eggs, inactivated by formaldehyde, purified by zonal centrifugation, and disrupted by a Triton X-100 process. This vaccine may contain 10 picograms of neomycin. ® The type and amount of viral antigens contained in VAXIGRIP JUNIOR conform to the current requirements of the Influenza Vaccine Committee of the Commonwealth Department of Health and New Zealand Communicable Diseases Control Advisory Committee. ACTIONS Influenza vaccines have been shown to give antibody responses and to provide protection against clinical illness in a proportion of vaccinees. Because the influenza virus is capricious antigenically and because significant changes in its antigenic behaviour may occur from time to time, protection afforded by VAXIGRIP®JUNIOR is limited to the strains from which the vaccine has been prepared or to closely related strains. VAXIGRIP® JUNIOR conforms in safety and sterility to the requirements of the Britis