ประเทศ: สหราชอาณาจักร
ภาษา: อังกฤษ
แหล่งที่มา: HMA (Heads of Medicines Agencies)
phenobarbital 60 mg
Chanelle Pharmaceutical Manufacturing Ltd
QN03AA02
Chewable tablet
Phenobarbital
Dogs
2013-04-24
Issued: August 2013 AN. 01712/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lepitil 60mg Flavoured Tablets for Dogs Lepitil vet 60mg Tablets for Dogs (SE) Phenobarbital 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENT: Each tablet contains: Phenobarbital 60mg For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet White, circular tablet with cross breakline on one side. The tablets can be divided into equal halves or quarters. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Phenobarbital is an antiepileptic agent for the prevention of seizures due to generalized epilepsy in dogs. 4.3 CONTRA-INDICATIONS Do not use in case of hypersensitivity to barbituates. Do not use in animals with serious impaired hepatic function. Do not use in animals with serious renal or cardiovascular disorders. Do not use in dogs weighing less than 6 kg body weight. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The decision to start antiepileptic drug therapy with Phenobarbital should be evaluated for each individual case and depends on number, frequency, duration and severity of seizures in dogs. Administration of tablets should occur at the same time(s) each day, and should be co- ordinated with feeding times in a consistent manner. Withdrawal or transition from other Issued: August 2013 AN. 01712/2011 Page 2 of 7 types of antieleptic therapy should be made gradually to avoid precipitating an increase in the frequency of seizures. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR U อ่านเอกสารฉบับเต็ม