Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
meloxicam
Ecuphar
QM01AC06
meloxicam
Dogs; Cats
Anti inflammatory and antirheumatic products
Oral suspension:Dogs:Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Solution for injection:Dogs:Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.Cats:Reduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.
Revision: 9
Withdrawn
2008-12-09
Medicinal product no longer authorised 14 B. PACKAGE LEAFLET Medicinal product no longer authorised 15 PACKAGE LEAFLET: ACTICAM 5 MG/ML SOLUTION FOR INJECTION FOR DOGS AND CATS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Ecuphar NV Legeweg 157-i B-8020 Oostkamp Belgium 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Acticam 5 mg/ml solution for injection for dogs and cats. Meloxicam. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Meloxicam 5 mg/ml. Ethanol anhydrous 150 mg/ml. 4. INDICATION(S) 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. 5. CONTRAINDICATIONS Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg. 6. ADVERSE REACTIONS Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported. In dogs, in very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported. In dogs, these side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal. In very rare cases anaphylactoid reactions may occur and should be treated symptomatically. Medicinal product no longer authorised 16 If adverse reactions occur Прочитайте повний документ
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Acticam 5 mg/ml solution for injection for dogs and cats. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Meloxicam 5 mg. EXCIPIENTS: Ethanol, anhydrous 150 mg. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. A clear yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 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. 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating animals. Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg. Do not use an oral follow-up therapy using meloxicam or other NSAIDs in cats, as no safe dosage for repeated oral administration has been established. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia. Medicinal product no longer authorised 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals If side effects occur, treatment should be discontinued. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain. Прочитайте повний документ