Land: Bretland
Tungumál: enska
Heimild: 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 2019 AN: 01038/2019 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval IBR-Marker Live 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 2 ml dose: ACTIVE SUBSTANCE: _Freeze-dried pellet_ Bovine Herpes Virus type 1 (BoHV-1), strain Difivac (gE-negative), modified live (attenuated) virus min. 10 5.0 CCID 50 * max. 10 7.0 CCID 50 * EXCIPIENT(S): _Diluent_ Water for injections 2 ml * CCID50 = Cell culture infective dose 50% 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 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. Revised: November 2019 AN: 01038/2019 Page 2 of 8 _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 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. Conseque Lestu allt skjalið