מדינה: ספרד
שפה: אנגלית
מקור: HMA (Heads of Medicines Agencies)
TRTV Strain BUT 1# 8544 and NDV Strain Clone 30 0 , TRTV Strain BUT 1# 8544 NDV Strain Clone 30 0
Intervet Intenational BV
QI01AA
Emulsion for injection
Chicken Layers
2009-08-13
Registration file / September 2008 LABELLING AND PACKAGE LEAFLET Registration file / September 2008 A. LABELLING Registration file / September 2008 PARTICULARS TO APPEAR ON THE OUTER PACKAGE 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Nobilis® TRT+ND 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Per dose of 0.5 ml: Inact. TRT antigen Inducing 10 log 2 Elisa ab units strain BUT 1#8544: Inact. NDV antigen Inducing 4 log 2 HI ab units per 1 / 50 dose or strain Clone 30: 50 PD 50 units as measured in the respective potency tests in chickens. Liquid paraffin: 215 mg 3. PHARMACEUTICAL FORM Emulsion for injection 4. PACKAGE SIZE 250/500 ml 5. TARGET SPECIES Turkeys (breeders) 6. INDICATION(S) Vaccine against Turkey Rhinotracheitis viruses and Newcastle Disease. 7. METHOD AND ROUTE(S) OF ADMINISTRATION Before use allow to reach ambient temp.(15-25˚C) and shake vigorously. i.m. or s.c. injection Read the package leaflet before use. 8. WITHDRAWAL PERIOD Registration file / September 2008 Zero days 9. SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous. Read the package leaflet before use. 10. EXPIRY DATE EXP: (month/year) Once broached use within 3 hours 11. SPECIAL STORAGE CONDITIONS Store in refrigerator (2-8 C). Do not freeze. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Dispose of waste material in accordance with local requirements. 13. THE WORDS "FOR ANIMAL קרא את המסמך השלם
Nobilis TRT+ND Renewal/January 2009 SUMMARY OF PRODUCT CHARACTERISTICS Nobilis TRT+ND Renewal/January 2009 1. NAME OF THE VETERINARY MEDICINAL PRODUCT NOBILIS® TRT+ND 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 0.5 ml: ACTIVE SUBSTANCES : Inactivated TRT antigen Inducing 10 log 2 Elisa strain BUT 1#8544: antibody units. Inactivated NDV antigen Inducing 4 log 2 HI strain Clone 30: antibody units per 1 / 50 dose or* Containing 50 PD 50 units as measured in the respective potency tests in chickens. * in accordance with the European Pharmacopoeia the potency of inactivated ND vaccines is measured in an antibody induction test. If the antibody induction test fails, a vaccination/challenge test with graded doses of vaccine is performed and the PD 50 is determined. ADJUVANT: Liquid paraffin 215 mg EXCIPIE NTS: For a list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Emulsion for injection 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Turkeys (breeders) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of turkeys to prevent clinical signs caused by Turkey Rhinotracheitis viruses and to prevent mortality and clinical signs caused by Newcastle Disease viruses. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS None Nobilis TRT+ND Renewal/January 2009 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS In case of accident קרא את המסמך השלם