País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC
Zoetis Ireland Limited
QI02AD01
BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC
Unknown
Lyophilisate and solvent for suspension for injection
POM(E)
Bovine
Bovine rhinotracheitis virus vaccine (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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 17/09/2015_ _CRN 7019768_ _page number: 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 field virus. _Onset of immunity_: 7 days after a single dose via intranasal administration or 21 days after a single dose via intramuscular administration as demonstrated in seronegative calves. _Duration of immunity following vaccination before 3 months of age_: After intranasal vaccination of calves aged 2 weeks or older w Llegiu el document complet