Land: Bretland
Tungumál: enska
Heimild: VMD (Veterinary Medicines Directorate)
Amlodipine
Orion Corporation
QC08CA01
Amlodipine
Chewable tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats
Cardio Vascular
Authorized
2015-04-28
Revised: March 2016 AN:01202/2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Amodip 1.25 mg chewable tablets for cats Amodip vet 1.25 mg chewable tablets for cats (DK,FI, SE, IS, NO, LT) Amlodipine 1.25 mg Ceva chewable tablets for cats (UK) Amlodipine Ceva 1.25 mg chewable tablets for cats (EE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ACTIVE SUBSTANCE: Amlodipine 1.25 mg (Equivalent to 1.73 mg of amlodipine besilate) EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Oblong in shape, score line on one side, beige to light brown tablets. Tablets can be divided into two equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic hypertension in cats. 4.3 CONTRAINDICATIONS Do not use in the case of cardiogenic shock and severe aortic stenosis. Do not use in cases of severe hepatic failure. Do not use in cases of known hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The primary cause and/or co-morbidities of hypertension, such as hyperthyroidism, chronic kidney disease and diabetes, should be identified and treated. It is recommended that hypertension is confirmed by measurement of systolic blood pressure before commencing therapy. Continued administration of the product over an extended period of time should be in accordance with an ongoing benefit/risk evaluation, performed by the pres Lestu allt skjalið