País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Infectious bovine rhinotraceitis virus
Zoetis UK Limited
QI02AD01
Infectious bovine rhinotraceitis virus
Powder and solvent for solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Live Viral Vaccine
Authorized
1999-02-10
Revised: November 2023 AN: 03127/2022 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval IBR-Marker Live lyophilisate and diluent for suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains: ACTIVE SUBSTANCE: FREEZE-DRIED PELLET: Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative), modified live (attenuated) virus * CCID 50 = Cell culture infective dose 50%. min. 10 5.0 CCID 50 * max. 10 7.0 CCID 50 * EXCIPIENT: DILUENT: Water for injections 2 ml For a full list of excipients, see section 6.1. 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. 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 Revised: November 2023 AN: 03127/2022 Page 2 of 10 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 following a single intranasal administration. 21 days following a single intramuscular administration. Duration of immunity following vaccination before 3 months of age: after intranasal vaccination of calves aged 2 weeks or older without maternally derived antibodies, immunity lasts until at least 3 months of age, when the animals should be revaccinated via intramuscular injection. A proportion of young calves may have maternally derived antibodies to BoHV-1, which may affect the immune response to vaccination. Llegiu el document complet