Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
PHENYTOIN
IPS Healthcare Limited
30 MG/5ml
Oral Suspension
2011-09-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epanutin 30 mg/5 ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of suspension contains 30mg Phenytoin Each 5ml also contains 1.044 g Sucrose, 24.66 microlitres Ethanol, 0.316 mg Carmoisine (E122), 0.1 mg Sunset Yellow FCF (E110). For a full list of excipients see 6.1. 3 PHARMACEUTICAL FORM Oral suspension. _Product imported from the UK:_ Viscous cherry red coloured oral suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and the prevention and treatment of seizures occurring during or following neurosurgery and/or severe head injury. Epanutin has also been employed in the treatment of trigeminal neuralgia but it should only be used as second line therapy if carbamazepine is ineffective or patients are intolerant to carbamazepine. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration only. _Dosage:_ Dosage should be individualized as there may be wide interpatient variability in phenytoin serum levels with equivalent dosage. Epanutin should be introduced in small dosages with gradual increments until control is achieved or until toxic effects appear. In some cases serum level determinations may be necessary for optimal dosage adjustments – the clinically effective level is usually 10 – 20mg/l (40 – 80 micromoles/l) although some cases of tonic-clonic seizures may be controlled with lower serum levels of phenytoin. With recommended dosage a period of seven to ten days may be required to achieve steady state serum levels with Epanutin and changes in dosage should not be carried out at intervals shorter than seven to ten days. Main Прочитать полный документ