国: 欧州連合
言語: 英語
ソース: EMA (European Medicines Agency)
meloxicam
Dopharma Research B.V.
QM01AC06
meloxicam
Pigs; Calves
Oxicams
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.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. 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 musculoskeletal disorders. For the relief of pain associated with equine colic.
Revision: 5
Authorised
2009-07-07
35 B. PACKAGE LEAFLET 36 PACKAGE LEAFLET FOR: Melovem 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: Dopharma Research B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands Manufacturer responsible for batch release: Dopharma B.V. Zalmweg 24 4941 VX Raamsdonksveer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains: ACTIVE SUBSTANCE: Meloxicam 5 mg EXCIPIENT(S): Benzyl alcohol 50 mg A clear, greenish 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. 37 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. 6. ADVERSE REACTIONS Transient swelling at the injection site was commonly reported in clinical studies following subcutaneous administration in cattle. Injection site swelling may be painful. Transient swelling at the injection site was observed in clinical studies following intramuscu 完全なドキュメントを読む
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Melovem 5 mg/ml solution for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Meloxicam 5 mg EXCIPIENT(S): Benzyl alcohol 50 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, greenish 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. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Treatment of calves with Melovem 20 minutes before dehorning reduces post-operative pain. Melovem 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. Treatment of piglets with Melovem before castration reduces post operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed. To obtain the 完全なドキュメントを読む