Land: Irland
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
phenobarbital 25 mg
Le Vet B.V
QN03AA02
Tablet
Phenobarbital
Dogs
2012-10-24
Issued: January 2013 AN: 01562/2011 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PHENOLEPTIL 25 mg Tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ACTIVE SUBSTANCE MG Phenobarbital 25 EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off white, circular, convex tablet with brown speckles and a crossed score line on one side (8 mm diameter). The tablets can be divided into two or four equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Prevention of seizures due to generalised epilepsy in dogs. 4.3 CONTRAINDICATIONS Do not use in case of hypersensivity to the active substance. 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 2.5 kg body weight. 4.4 SPECIAL WARNINGS FOR THE 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. Issued: January 2013 AN: 01562/2011 Page 2 of 7 General recommendations for initiating therapy include a single seizure occurring more than once every 4-6 weeks, cluster seizure activity (i.e. more than one seizure within 24 h) or status epilepticus regardless of frequency. To achieve successful therapy, administration of tablets must be at the same time each day. Withdrawal or transition from other types of antiepileptic therapy should be mad Læs hele dokumentet