Maa: Itävalta
Kieli: englanti
Lähde: HMA (Heads of Medicines Agencies)
meloxicam 5 mg/ml
aniMedica GmbH
QM01AC06
Solution for injection
meloxicam
Cats, Dogs
2011-10-26
Issued: March 2012 AN: 00648/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Animeloxan, 5 mg/ml, solution for injection for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains ACTIVE SUBSTANCE: Meloxicam 5 mg EXCIPIENTS: Ethanol, anhydrous 110.60 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 Dog and cat 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia. Issued: March 2012 AN: 00648/2010 Page 2 of 5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS If adverse reactions occur, treatment should be discontinued and the advice of Lue koko asiakirja