국가: 유럽 연합
언어: 영어
출처: EMA (European Medicines Agency)
meloxicam
Dechra Veterinary Products A/S
QM01AC06
meloxicam
Dogs; Cats
Antiinflammatory and antirheumatic products
Oral suspension:Dogs:Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.Solution for injection: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 postoperative pain after ovariohysterectomy and minor soft tissue surgery
Revision: 7
Withdrawn
2006-04-10
Medicinal product no longer authorised 14 B. PACKAGE LEAFLET Medicinal product no longer authorised 15 PACKAGE LEAFLET Flexicam 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 MARKETING AUTHORISATION HOLDER Dechra Veterinary Products A/S Mekuvej 9 DK-7171 Uldum Denmark MANUFACTURER FOR THE BATCH RELEASE Accord Healthcare Limited Sage House 1 st Floor, 319 Pinner Road North Harrow, Middlesex HA1 4HF United Kingdom 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Flexicam 5 mg/ml solution for injection for dogs and cats Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS 1 ml of solution for injection contains 5 mg of meloxicam. Other substances: Ethanol anhydrous 150 mg/ml. 4. INDICATIONS 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 case 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. Medicinal product no longer authorised 16 6. ADVERSE REACTIONS Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood and apathy have occasionally been reported. In dogs, these side effects occur generally within the first treatment week and are in most cases transient and disappear follo 전체 문서 읽기
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 Flexicam 5 mg/ml solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ONE ML CONTAINS Active substance: Meloxicam 5 mg Excipients: Ethanol, anhydrous 150 mg For a 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 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 case 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. People wi 전체 문서 읽기