국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Phenobarbital
Dechra Regulatory B.V.
QN03AA02
Phenobarbital
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
phenobarbital
2011-06-17
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT PHENOLEPTIL 50 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Phenobarbital 50 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off white, circular, biconvex tablets with brown speckles and a score line on one side (9 mm diameter). The tablet can be divided into two 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 hypersensitivity to the active substance or to other barbiturates. Do not use in animals with serious impaired hepatic function. Do not use in animals with serious renal or cardiovascular disorders. 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. 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 made gradually to avoid precipitating an increase in the frequency of seizures. Some of the dogs are free of epileptic seizures during the treatment, but some of the dogs show only a seizure reduction, and some of the dogs are considered to be non-responders. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Caution is recommended in animals with impaired hepatic and renal function, hypovolemia, anaemia and cardiac or respiratory dysfunction. 3 The chance of hepatotoxic side effects can be diminished or delayed using an effective dose that is as 전체 문서 읽기