País: Francia
Idioma: inglés
Fuente: HMA (Heads of Medicines Agencies)
Avian rhinotracheitis virus 0
Intervet Intenational BV
QI01AA17
Chicken Layers, Turkeys
2012-02-28
label-leaflet Nobilis RT inac (FR/V/0138/001/R/001) D90 16/10/2008 1 LABELLING AND PACKAGE LEAFLET label-leaflet Nobilis RT inac (FR/V/0138/001/R/001) D90 16/10/2008 2 A. LABELLING label-leaflet Nobilis RT inac (FR/V/0138/001/R/001) D90 16/10/2008 3 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis RT inac Emulsion for injection 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 0.5 ml: ACTIVE SUBSTANCE : Inactivated ARTV (strain But1#8544) subtype A inducing 10 log 2 ELISA units Adjuvant: Liquid paraffin 215 mg 3. PHARMACEUTICAL FORM Emulsion (water-in-oil) for injection [_only mentioned once_] 4. PACKAGE SIZE 250 ml and 500 ml vials 5. TARGET SPECIES Chickens and turkeys (future layers and breeders) 6. INDICATION(S) Active immunisation against Avian Rhinotracheitis virus 7. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Intramuscular injection 8. WITHDRAWAL PERIOD Zero days 9. SPECIAL WARNING(S), IF NECESSARY label-leaflet Nobilis RT inac (FR/V/0138/001/R/001) D90 16/10/2008 4 This is a water-in-oil emulsion. Accidental self injection is dangerous, please follow instructions in leaflet. 10. EXPIRY DATE Exp. month/year: 11. SPECIAL STORAGE CONDITIONS Store dark at 2 - 8 C. Do not freeze. Broached vials should be used immediately after opening. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATER Leer el documento completo
SPC Nobilis RT inac (FR/V/0138/001/R/001) - D90 1 SUMMARY OF PRODUCT CHARACTERISTICS SPC Nobilis RT inac (FR/V/0138/001/R/001) - D90 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis RT inac (AT, BE, DE, DK, EL, ES, FI, IT, NL, LU, PT) FR: Nobilis RTV inac IE, UK: Nobilis TRT inac 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per 0.5 ml dose: Active substance: Inactivated Avian rhinotracheitis virus, strain But 1 #8544: ≥ 10 log 2 ELISA units* Adjuvant: liquid paraffin: 215 mg *serological response in chickens For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to nearly white oily emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET S PECIES Chickens and turkeys (future layers and breeders). 4.2 INDICATION FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of chickens to reduce clinical signs, including egg-drop, of Swollen Head Syndrome due to infection with avian pneumovirus. Active immunisation of turkeys to reduce clinical signs due to infection with Turkey Rhinotracheitis virus. The onset of immunity is 3 weeks and the duration of immunity is one laying period. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Vaccinate only healthy animals. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS SPC Nobilis RT inac (FR/V/0138/001/R/001) - D90 3 To the user: This product contains mineral oil. Accidental injection Leer el documento completo