Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
meloxicam
Le Vet Beheer B.V
QM01AC06
meloxicam
Horses; Dogs; Cattle; Cats; Pigs
Oxicams
DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsReduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.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: 9
Authorised
2013-04-22
17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE CARTON FOR THE 10 ML, 20 ML AND 100 ML LABEL FOR 100 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs meloxicam 2. STATEMENT OF ACTIVE SUBSTANCES Meloxicam 5 mg/ml 3. PHARMACEUTICAL FORM Solution for injection 4. PACKAGE SIZE 10 ml 20 ml 100 ml 5. TARGET SPECIES Dogs, cats, cattle (calves) and pigs 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Dogs, Cattle: Single subcutaneous or intravenous injection Cats: Single subcutaneous injection Pigs: Single intramuscular injection Read the package leaflet before use 8. WITHDRAWAL PERIOD(S) Withdrawal period: CATTLE: Meat and offal: 15 days PIGS: Meat and offal: 5 days 18 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATE EXP (month/year) Once broached, use by…. 11. SPECIAL STORAGE CONDITIONS Read the package leaflet before use. 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 Le Vet Beheer B.V. Wilgenweg 7 3421 TV Oudewater The Netherlands 16. MARKETING AUTHORISATION NUMBER(S) EU/2/13/148/001 EU/2/13/148/002 EU/2/13/148/003 EU/2/13/148/008 EU/2/13/148/009 17. MANUFACTURER’S BATCH NUMBER Batch {number} 19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR 10 ML AND 20 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs meloxicam 2. QUANTITY OF THE ACTIVE SUBSTANCE(S) Meloxicam 5 mg/ml 3. CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 ml 20 ml 4. ROUTE(S) Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Meloxidolor 5 mg/ml solution for injection for dogs, cats, 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 Dogs, cats, cattle (calves) and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES DOGS: Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery. CATS: Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery. 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. 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 cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs and cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in dogs and cats less than 6 weeks of age nor in cats of less than 2 kg. 3 Do not use in cattle and pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. 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. Lestu allt skjalið