Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
BOVINE HERPES VIRUS TYPE 1 STRAIN DIFIVAC
Pfizer Healthcare Ireland
QI02AD01
Lyophilisate and solvent for suspension for injection
Immunological - Live Vaccine
Bovine
2001-11-27
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. 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. _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. Consequently, the protection afforded by the vaccine may not be complete until the revaccination at 3 months of age. _Duration of immunity following vaccination at or after 3 months of age_: 6 months. Composition for 2 ml dose: ACTIVE SUBSTANCE: Freeze-dried pellet Bovine Herpes Virus type 1 (BHV-1), strain Difivac (g Прочитайте повний документ