Država: Njemačka
Jezik: engleski
Izvor: HMA (Heads of Medicines Agencies)
diltiazem hydrochloride 10 mg/g
Arnolds Veterinary Products Limited
QC08DB01
Coated tablet
diltiazem
Cats
2010-09-16
Revised: September 2010 AN: 00678/2010 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT HyperCard 10 mg Coated Tablets for Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance Diltiazem EXCIPIENTS Tartrazine (E102) Titanium dioxide, (E171) For a full list of excipients, see section 6.1. Quantitative composition 9.20 mg (equivalent to 10 mg of Diltiazem hydrochloride) 0.11 mg 1.1 mg 3. PHARMACEUTICAL FORM Coated tablet. A yellow coated biconvex tablet. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the therapeutic treatment of feline primary hypertrophic cardiomyopathy. 4.3 CONTRAINDICATIONS Do not use in animals suffering from AV block (2 nd or 3 rd ), hypotension or sick sinus syndrome. Diltiazem should not be given to animals suffering from hepatic disease. Do not use in animals suffering from renal disease. Do not use in cats less than 12 months old. Do not use in cats weighing less than 3 kg. Do not use in animals that are hypersensitive to Diltiazem. Do not use in cats with severe bradycardia or arterial hypotension. Do not use in conjunction with blockers, digitalis or digoxin. Do not use in pregnant or lactating females. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: September 2010 AN: 00678/2010 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Hepatic failure may increase the plasma concentra Pročitajte cijeli dokument