Product Summary File - WHO

1 CompositionOne vial of powder and solvent for solution for injection for one immunisation dose (1 ml) contains: inactivated rabies virus (strain flury LEP), potency > system: primary chicken fibroblast cell culturesOther ingredients:TRIS-(hydroxymethyl-)aminome thane, sodium chloride, EDTA (Titriplex III), potassium-L-glutamate, polygeline, saccharose, water for injectionsPresentation and contents by weight, volume or number of itemsPowder and solvent for solution for injectionAfter dissolution of the white lyophilisate ( powder ), a clear colourless solution find enclosed our full range of pack/container sizes.

2 Please note that some itemslisted may not be available in all contains: One vial of lyophilisate for one immunisation dose (1 ml) One ampoule containing 1 ml water for injectionsPack contains: One vial of lyophilisate for one immunisation dose (1 ml) One ampoule containing 1 ml water for injections One disposable syringePack contains: Five vials, each with lyophilisate for one immunisation dose (5 x 1 ml) Five ampoules, each containing 1 ml water for injections Five disposable syringesPack contains: 30 vials, each with lyophilisate for 1 immunisation dose (30 x 1 ml)Pack contains: 30 ampoules, each containing 1 ml water for injectionsDisposable syringes are provided or indication categoryVaccinesName and address of the holder of the marketing authorisationNovartis Vaccines and Diagnostics GmbH & Co.

3 KGPO Box 1630D-35006 MarburgGermanyIndicationsActive immunisation against ) Pre-exposure immunisation (preventative, priorto exposure):Immunisation priorto possible infection with rabies, particularly for vets, veterinarymedicine students, animal keepers, hunters, forestry workers, animal handlers, butchers,personnel in rabies research laboratories etc., or prior to visits to areas in which rabiesis endemic (rabies infected areas).b) Post-exposure treatment (afterexposure):Treatment aftercontact with animals which are rabid or suspected to be rabid, orafter contact with an inoculated rabies further details, see enclosed ) Immunisation priorto exposureIt is advisable to avoid pre-exposure (prophylactic)

4 Immunisation in individuals withacute disorders requiring complications arise after vaccination, this should be considered a contraindicationfor further administration of the same vaccine, until the causes of the complicationshave been individuals with known allergy to one of the constituents of Rabipur, use of thisvaccine is ) Treatment afterexposureIn view of the fact that rabies is a fatal disease, there are no contraindications toimmunisation after suspected exposure (see section "Special precautions for use").

5 Pregnancy and breast-feedingNo cases of harm attributable to use of this vaccine during pregnancy have been observedto date in mothers or is not known whether Rabipur passes into breast G26 00479 (17984A)1 Date of revision of the package leafletSeptember 2006 Additional InformationThis vaccine conforms to the World Health Organisation (WHO) requirements andcontains no antibody concentration achieved by the immunisation falls gradually; boosterdoses are therefore required to maintain immunisations and all immunoglobulins administered should be entered by thedoctor, with the name of the preparation (proprietary name) and Lot.

6 No., in the inter-national immunisation record. Optimal immunity will only be conferred if the full im-munisation schedule is Active substance: Inactivated rabies virusPackage leafletExposurecategoryIIIIIIC ontact with a rabid orsuspected rabid*wild or domestic animal Touching/feedinganimals, but clearly nocontact with their saliva;patient's skinundamaged prior to andduring contact Animal has nibbled orlicked exposed skin ofthe patient Contact with saliva Superficial, non-bleeding, scratchesmade by the animal,with the exception ofscratches on the head,neck, shoulder region,arms and hands(see exposure grade III) All bites Bleeding scratches All scratches on thehead, neck, shoulderregion, arms, and hands Contact of patient'smucous membrane withanimal saliva(e.)

7 G. licking, spray)Contact with aninoculated animalcarcass Touching inoculated carcass; skin intact Touching inoculatedcarcass; skin damaged Contact ofinoculated carcasswith mucousmembrane or freshskin woundTreatment scheduleNo treatment cases of uncertainty,immunisation to beadministered as perschedule B (Table 2)Immediate treatment asspecified in schedule cases of uncertainty, simultaneous administra-tion of vaccine and immu-noglobulin (active andpassive immunisation) should be administedas specified in schedule C(Table 2).

8 If the animal proves to behealthy after examination,it is advisable to continuetreatment as in schedule patient's immunityagainst immediate simul-taneous administration ofvaccine and immunoglo-bulin (active and passiveimmunisation) as specifiedin schedule C (Table 2).If the animal proves to behealthy after examination,it is advisable to continuetreatment as in schedule patient s immunityagainst of exposureSchedule AImmunisation prior toexposureOne injection of on days: 0, 7, and 21 or 28 Schedule BImmunisation after exposureOne injection of Rabipur days: 0, 3, 7, 14, 28 (5-dose schedule)orOne dose of Rabipur to begiven into the right deltoidmuscle and one dose into theleft deltoid muscle on day 0.

9 And one dose to be appliedinto the deltoid muscle ondays 7 and 21 (2-1-1 regimen).In small children the vaccine isto be given into the CSimultaneous prophylaxisafter exposureGive Rabipur as in schedule B + 1 x 20 IU/kg BW human rabiesimmunoglobulin** or 40 IU/kgBW equine rabies immuno-globulin simultaneously withthe first dose of no rabies immunoglobulinis available at the time of thefirst vaccination, it must beadministered no later than 7days after the first vaccination.*Persons who have received less than three immunisation doses, or a vaccine ofdoubtful potency or origin** Observe manufacturer s instructions!

10 (Based on the 1997 WHO guidelines)* All animals exhibiting abnormal behaviour in an area which has been officially decla-red as rabies endemic area must be considered potentially rabid. The corpses of rabidanimals can also transmit :Where indicated, prophylactic immune treatment should be given as soon aspossible!Table 2: Pre-exposure immunisation and post-exposure treatment of indivi-duals with no or inadequate* immunityTable 1: Appropriate rabies treatment based on different categories of 10:07 Seite 1 (Schwarz/Process Black Bogen) Product Summary FileRabipurNovartis Vaccines and Diagnostics GmbH & Co.