Land: Den europeiske union
Språk: engelsk
Kilde: EMA (European Medicines Agency)
meloxicam
Le Vet Beheer B.V.
QM01AC06
meloxicam
Horses
Oxicams
Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.
Revision: 4
Authorised
2015-09-08
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: NOVAQUIN 15 MG/ML ORAL SUSPENSION FOR HORSES 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Le Vet Beheer B.V. Wilgenweg 7 3421 TV Oudewater The Netherlands Manufacturer responsible for batch release: Produlab Pharma B.V. Forellenweg 16 4941 SJ Raamsdonksveer The Netherlands 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Novaquin 15 mg/ml oral suspension for horses Meloxicam 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One ml contains: ACTIVE SUBSTANCE Meloxicam 15 mg. EXCIPIENTS Sodium benzoate 1.75 mg Yellowish-green viscous oral suspension. 4. INDICATION(S) Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses. 5. CONTRAINDICATIONS Do not use in pregnant or lactating mares. Do not use in horses 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 horses less than 6 weeks of age. 6. ADVERSE REACTIONS 16 Isolated cases of adverse reactions typically associated with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). The clinical signs were reversible. Loss of appetite, lethargy, abdominal pain and colitis have been reported in very rare cases. Anaphylactoid reactions, which may be serious (including fatal), may occur in very rare cases and should be treated symptomatically. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 an Les hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Novaquin 15 mg/ml oral suspension for horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Meloxicam 15 mg EXCIPIENTS: Sodium benzoate 1.75 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension. Yellowish-green viscous oral suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses. 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating mares. Do not use in horses 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 horses less than 6 weeks of age. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Avoid use in any dehydrated, hypovolemic or hypotensive animals as there is a potential risk of renal toxicity. Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product. 3 In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). The clinical signs were reversible. Loss of appetite, lethargy, abdominal pain and colitis have been reported in very rare cases. Anaphylactoid reactions, which may be serious (including fatal), may occur in very rare cases and should be treated symptomatically. I Les hele dokumentet