País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
tildipirosin
Intervet International BV
QJ01FA
tildipirosin
Pigs; Cattle
Antiinfectives for systemic use
40-mg/ml solution for injection for pigsTreatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica and Haemophilus parasuis sensitive to tildipirosin.The presence of the disease in the herd should be confirmed before metaphylaxis is implemented.180-mg/ml solution for injection for cattleFor the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin.The presence of the disease in the herd should be confirmed before preventive treatment.
Revision: 4
Authorised
2011-05-06
24 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CATTLE VIAL (20 ML, 50 ML) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) 180 mg/ml of tildipirosin 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml 50 ml 4. ROUTE OF ADMINISTRATION SC 5. WITHDRAWAL PERIOD Withdrawal period: Meat and offal: 47 days. See package leaflet. 6. BATCH NUMBER Batch: 7. EXPIRY DATE EXP: Once opened, use by: 8. THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 25 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE CATTLE VIAL (100 ML, 250 ML) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 180 mg/ml solution for injection for cattle tildipirosin 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES 180 mg/ml of tildipirosin 3. PHARMACEUTICAL FORM Solution for injection 4. PACKAGE SIZE 100 ml 250 ml 5. TARGET SPECIES Cattle 6. INDICATION(S) 7. METHOD AND ROUTE OF ADMINISTRATION Subcutaneous injection Read the package leaflet before use. 8. WITHDRAWAL PERIOD Withdrawal period: Meat and offal: 47 days. Not authorised for use in lactating animals producing milk for human consumption. Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition. 9. SPECIAL WARNINGS 26 Read the package leaflet before use. Accidental injection is dangerous. 10. EXPIRY DATE EXP: Once opened, use by: 11. SPECIAL STORAGE CONDITIONS Do not store above 25 ° C. 12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY Disposal: _ _ read package leaflet. 13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE For animal treatment only. To be supplied only on veterinary prescription. 14. THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children. 15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B. V. Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZUPREVO 40 mg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Tildipirosin 40 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellowish solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and metaphylaxis of swine respiratory disease (SRD) associated with _Actinobacillus _ _pleuropneumoniae_ , _Pasteurella multocida, Bordetella bronchiseptica _ and _ Haemophilus parasuis_ sensitive to tildipirosin. The presence of the disease in the herd should be confirmed before metaphylaxis is implemented. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to macrolide antibiotics or to any of the excipients. Do not administer intravenously. Do not administer simultaneously with other macrolides or lincosamides (see section 4.8) 4.4 SPECIAL WARNINGS In line with responsible use principles, metaphylactic use of Zuprevo is only indicated in severe outbreaks of SRD caused by the indicated pathogens. Metaphylaxis implies that clinically healthy animals in close contact with diseased animals are administered the veterinary medicinal product at the same time as the treatment of the clinically diseased animals, to reduce the risk for development of clinical signs. The efficacy of metaphylactic use of Zuprevo was demonstrated in a placebo controlled multi-centre field study, when outbreak of clinical disease was confirmed (i.e. animals in at least 30% of the pens sharing the same airspace showed clinical signs of SRD, including at least 10% animals per pen within 1 day; or 20% within 2 days or 30% within 3 days). Following metaphylactic use, approximately 86% of the healthy animals remained free of clinical signs of disease (as compared to approximately 65% of animals in the untreated control group). 3 4.5 SPECIAL PRECAUTIONS FOR USE Special p Llegiu el document complet