Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
meloxicam
Boehringer Ingelheim Vetmedica GmbH
QM01AC06
meloxicam
Pigs; Cattle
Anti-inflammatory and anti-rheumatic products, non-steroids
Novem 5-mg/ml solution for injection for cattle and pigs:CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For the relief of postoperative pain following dehorning in calves.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For the relief of postoperative pain associated with minor soft-tissue surgery such as castration.Novem 20-mg/ml solution for injection for cattle and pigs:CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration 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 postoperative pain following dehorning in calves.PigsFor use in noninfectious 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.Novem 40 mg/ml solution for injection for 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.
Revision: 13
Authorised
2004-03-02
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: Novem 5 mg/ml solution for injection for cattle and pigs 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Labiana Life Sciences S.A. Venus, 26 Can Parellada Industrial 08228 Terrassa SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Novem 5 mg/ml solution for injection for cattle and pigs Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS One ml contains: Meloxicam 5 mg Ethanol 150 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 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 the relief of post-operative pain associated with minor soft tissue surgery such as castration. 5. CONTRAINDICATIONS 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 diarrhoea in cattle, do not use in animals of less than one week of age. Do not use in pigs less than 2 days old. 38 6. ADVERSE REACTIONS In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies. Anaphylactoid reactions which may be serious (including fatal), have been observed very rarely from post-marketing safety experience and Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Novem 5 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Meloxicam 5 mg EXCIPIENT: Ethanol 150 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 (calves and young cattle) and pigs 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 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 the relief of post-operative pain associated with minor soft tissue surgery such as castration. 4.3 CONTRAINDICATIONS 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 diarrhoea in cattle, do not use in animals of less than one week of age. Do not use in pigs less than 2 days old. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment of calves with Novem 20 minutes before dehorning reduces post-operative pain. Novem alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed. 3 Treatment of piglets with Novem before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the best possible pain relieving Прочетете целия документ