Country: হাঙ্গেরি
ভাষা: ইংরেজি
সূত্র: HMA (Heads of Medicines Agencies)
potassium bromide 325 mg
Genitrix Limited
QN05CM11
Tablet
Bromides
Dogs
2011-09-28
Revised: June 2013 AN: 01432/2012 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Libromide 325 mg Tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Potassium bromide 325 mg For full list of excipients see Section 6.1 3. PHARMACEUTICAL FORM Tablet. Plain white circular biconvex 9.5 mm tablet with a single scored line on one face. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES An anti-epileptic agent for use as an adjunct to phenobarbital in the control of refractory cases of epilepsy in dogs. 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to bromide, or to any of the excipients. Do not use in dogs with severe renal insufficiency. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES It is advisable not to change the dog’s diet during therapy due to the effect of chloride intake on serum bromide concentrations, see section 4.8. 4.5 SPECIAL PRECAUTIONS FOR USE i Special precautions for use in animals Do not abruptly discontinue therapy as this may precipitate seizures. In cases of renal insufficiency, in order to prevent bromide accumulation (see section 5.2), administer a reduced dose of Libromide and monitor the dog closely. A reduction in chloride intake could cause bromide intoxication (see section 4.8). Revised: June 2013 AN: 01432/2012 Page 2 of 6 Administration on an empty stomach may induce vomiting. Dogs weighing l সম্পূর্ণ নথি পড়ুন