CHIRON VACCINES
"RABIPUR ® Product Information AUSTR 100582 Page 1 of 13 Version 2.0 RABIPUR ® Inactivated Rabies Virus Vaccine DESCRIPTION RABIPUR ® is an inactivated rabies virus vaccine, derived from the fixed -virus strain, Flury LEP. The virus is propagated in aPurified Chick Embryo Cell
(PCEC) culture, inactivated using - propiolact one and purified viacentrifugation. It is supplied in a single - dose presentation consisting of a vial containing lyophilised powder (vaccine component), accompanied by an ampoule of diluent (Water for Injections). Each 1.0mL dose of the reconstituted vaccine contains no less than 2.5IU of inactivated rabies virus, in accordance with the World Health Organisation requirements. Each 1.0mL dose of the reconstituted vaccine also contains the following excipients: trometamol (3.5mg), sodium chloride (4.5mg) , disodium edetate (0.25mg), monopotassium glutamate (0.9mg), polygeline (10.5mg), sucrose (60mg) and water for injections (1.0mL). The quantities of each excipient (excluding water for injection) will vary dependent on virus concentration in the harvested material. The neomycin, chlortetracycline and amphotericin B are used in the manufacturing process of this vaccine and may be present in trace amounts. The manufacture of this product includes exposure to bovine derived materials. No evide nce exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product"
RABIES VACCINE
CHIRON VACCINES
"RABIPUR ® Product Information AUSTR 100582 Page 1 of 13 Version 2.0 RABIPUR ® Inactivated Rabies Virus Vaccine DESCRIPTION RABIPUR ® is an inactivated rabies virus vaccine, derived from the fixed -virus strain, Flury LEP. The virus is propagated in aPurified Chick Embryo Cell
(PCEC) culture, inactivated using - propiolact one and purified viacentrifugation. It is supplied in a single - dose presentation consisting of a vial containing lyophilised powder (vaccine component), accompanied by an ampoule of diluent (Water for Injections). Each 1.0mL dose of the reconstituted vaccine contains no less than 2.5IU of inactivated rabies virus, in accordance with the World Health Organisation requirements. Each 1.0mL dose of the reconstituted vaccine also contains the following excipients: trometamol (3.5mg), sodium chloride (4.5mg) , disodium edetate (0.25mg), monopotassium glutamate (0.9mg), polygeline (10.5mg), sucrose (60mg) and water for injections (1.0mL). The quantities of each excipient (excluding water for injection) will vary dependent on virus concentration in the harvested material. The neomycin, chlortetracycline and amphotericin B are used in the manufacturing process of this vaccine and may be present in trace amounts. The manufacture of this product includes exposure to bovine derived materials. No evide nce exists that any case of vCJD (considered to be the human form of bovine spongiform encephalitis) has resulted from the administration of any vaccine product"
RABIES VACCINE