País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
meloxicam
Zoetis Belgium SA
QM01AC06
meloxicam
Horses; Pigs; Cattle
Anti-inflammatory and anti-rheumatic products, non-steroids
CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. For the relief of post-operative pain following dehorning in calves.PigsFor the reduction of symptoms of lameness and inflammation in non-infectious locomotor disorders and for adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. For the relief of pain associated with equine colic.
Revision: 7
Authorised
2012-12-06
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: CONTACERA 20 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea Co. Galway IRELAND 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 20 mg/ml solution for injection for cattle, pigs and horses meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains: Meloxicam 20 mg Ethanol (96%) 159.8 mg Clear, yellow solution. 4. INDICATION(S) CATTLE: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. For the relief of post-operative pain following dehorning in calves. PIGS: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis- agalactia syndrome) with appropriate antibiotic therapy. HORSES: For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. For the relief of pain associated with equine colic. 30 5. CONTRAINDICATIONS Do not use in horses less than 6 weeks of age. Do not use in pregnant or lactating mares. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substance or to any of the excipients. For the treatment of dia Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Contacera 20 mg/ml solution for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Meloxicam 20 mg EXCIPIENT: Ethanol (96%) 159.8 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. For the relief of post-operative pain following dehorning in calves. PIGS: For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis- agalactia syndrome) with appropriate antibiotic therapy. HORSES: For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders. For the relief of pain associated with equine colic. 3 4.3 CONTRAINDICATIONS See also section 4.7. Do not use in horses less than 6 weeks of age. Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. Do not use in case of hypersensitivity to the active substance(s) or to any of the excipient(s). For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment of calves with Contacera 20 minutes before dehorning reduces post-operative pain. Contacera alone will not provide ad Llegiu el document complet