Land: Österrike
Språk: engelska
Källa: HMA (Heads of Medicines Agencies)
BHV-1 strain GK/D 0
Intervet Intenational BV
QI02AD01
Suspension for injection
bovine rhinotracheitis virus (IBR)
Cattle
2011-12-20
NL/V/0105/001/II/002 Day 90 label-leaflet – 10-5-2007 Concurrent Use 1/7 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis IBR Marker Live 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose (2 ml): BHV-1, strain GK/D (gE¯ ): 10 5.7 - 10 7.3 TCID 50 . 3. PHARMACEUTICAL FORM Lyophilisate for suspension for i.m. injection. / intranasal application. 4. PACKAGE SIZE 1, 2, 5, 10, 25, 50 or 100 doses / 10x 1, 2, 5, 10, 25, 50 or 100 doses 5. TARGET SPECIES Cattle 6. INDICATION(S) Active immunisation against BHV-1 infection in cattle 7. METHOD AND ROUTE(S) OF ADMINISTRATION I.M. / intranasal 1 dose of 2 ml. Read the package leaflet before use. (_This sentence will only be mentioned once_) 8. WITHDRAWAL PERIOD Withdrawal period: zero days 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. (_This sentence will only be mentioned once_) 10. EXPIRY DATEUse within 3 hours after reconstitution. NL/V/0105/001/II/002 Day 90 label-leaflet – 10-5-2007 Concurrent Use 2/7 11. SPECIAL STORAGE CONDITIONS Store at 2-8°C in the dark 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Read the package leaflet before use. (_This sentence will only be mentioned once_) 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only Subject to medical prescription (_to be replaced Läs hela dokumentet
Bovilis IBR marker Live SPC End of procedure NL/V/0105/001/II/003-004 13-12-2007 1 Final SPC 13-12-07 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis IBR marker Live 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 2 ml reconstituted vaccine: ACTIVE SUBSTANCE(S) BHV-1, strain GK/D (gE¯ ): 10 5.7 - 10 7.3 TCID 50 . ADJUVANT(S) None SOLVENT (Unisolve) Isotonic phosphate buffered saline. For a list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for intramuscular injection or intranasal application. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of cattle to reduce the intensity and duration of the clinical respiratory signs induced by an infection with BHV-1 and to reduce nasal excretion of field virus. Onset of immunity: An increase in immunity was demonstrated 4 days after intranasal vaccination and 14 days after intramuscular vaccination of 3 month old seronegative animals. Duration of immunity: After intranasal administration to 2 week old calves without maternal antibodies, immunity lasts at least until the age of 3-4 months, when the animals should be revaccinated. In the presence of maternally derived antibodies, the protection of the vaccine may not be complete until this revaccination. Revaccination at 3-4 months of age results in protective immunity that lasts for at least 6 months. Bovilis IBR marker Live SPC End of procedure NL/V/0105/001/II/003-004 13-12-2007 2 Si Läs hela dokumentet