Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC
Zoetis Ireland Limited
QI02AD01
BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC
Lyophilisate and solvent for suspension for injection
POM (E): Prescription Only Exempt as defined in relevant national legislation
Bovine
bovine rhinotracheitis virus (IBR)
Immunological - Live Vaccine
Authorised
2013-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval IBR-Marker Live. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Lyophilisate and diluent for suspension for injection. Lyophilisate: Slightly coloured freeze-dried pellet. Diluent: Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. Composition for 2 ml dose: ACTIVE SUBSTANCE: Freeze-dried pellet Bovine Herpes Virus type 1 (BHV-1), strain Difivac (gE-negative), min. 10 5.0 CCID 50 modified live (attenuated) virus max. 10 7.0 CCID 50 EXCIPIENT: Diluent Water for injections 2 ml *CCID 50 = Cell culture infective dose 50% For a full list of excipients, see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _7_ _/_ _0_ _9_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _9_ _7_ _6_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cattle against Infectious Bovine Rhinotracheitis (IBR), to reduce virus shedding and clinical signs including, in female cattle, abortions associated with BoHV-1 infection. A reduction of abortion associated with BoHV-1 infections has been demonstrated during the second trimester of gestation upon challenge 28 days after vaccination. Vaccinated cattle can be differentiated from field virus infected animals due to the marker deletion, unless the cattle were previously vaccinated with a conventional vaccine or infected with fiel Perskaitykite visą dokumentą