Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
meloxicam
Zoetis Belgium SA
QM01AC06
meloxicam
Dogs
Oxicams
Alleviation of inflammation and pain in both acute and chronic musculoskeletal disorders in dogs.
Revision: 5
Withdrawn
2012-02-23
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 RevitaCAM 5 mg/ml oromucosal spray for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Meloxicam 5 mg EXCIPIENTS: Ethyl alcohol 150 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal spray Yellow colloidal dispersion 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 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 dogs less than 6 weeks of age. This product is for dogs and should not be used in cats as it is not suitable for use in this species. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Medicinal product no longer authorised 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after administration of the product. People with known hypersensitivity to Non Steriodal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Typical adverse drug reactions of NSAI Læs hele dokumentet
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 RevitaCAM 5 mg/ml oromucosal spray for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Meloxicam 5 mg EXCIPIENTS: Ethyl alcohol 150 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oromucosal spray Yellow colloidal dispersion 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs. 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 dogs less than 6 weeks of age. This product is for dogs and should not be used in cats as it is not suitable for use in this species. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity. Medicinal product no longer authorised 3 Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after administration of the product. People with known hypersensitivity to Non Steriodal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Typical adverse drug reactions of NSAI Læs hele dokumentet