País: Regne Unit
Idioma: anglès
Font: VMD (Veterinary Medicines Directorate)
Diltiazem Hydrochloride
Dechra Limited
QC08DB01
Diltiazem Hydrochloride
Coated tablet
POM-V - Prescription Only Medicine – Veterinarian
Cats
Cardio Vascular
Authorized
2000-08-16
Revised: October 2015 AN: 00817/2015 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 β blockers, digitalis or digoxin. Do not use in pregnant or lactating females. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Revised: October 2015 AN: 00817/2015 Page 2 of 5 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Hepatic failure may increase the plasma concentration of diltiazem. Monitor glucose levels carefully in diabetic animals. Use with caution in cats suffering from congestive heart failure. Cats with possible pre-existing thyroid problems or hyperthyroidism should be treated for this first and then reassessed prior to commencing treatment with Diltiazem. Clinical examination to assess the effectiveness of treatment should be performed after 8 weeks. Cardiac rate should be monitored prior to treatment commencing and at every follow up visit. ii. Special precautions for the person admini Llegiu el document complet