Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
VALPROATE SODIUM
Imbat Limited
200 Milligram
Tablets Gastro-Resistant
2009-07-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epilim Enteric 200mg Gastro-resistant Coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant tablet contains 200mg of sodium valproate Excipients: Contains amaranth lake (E123) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant coated tablets. _Product imported from the UK:_ Lilac, biconvex, gastro-resistant coated tablet, plain on both sides 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of generalised, partial or other epilepsy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epilim Enteric 200mg gastro-resistant coated tablets are for oral administration. Daily dosage requirements vary according to age and body weight. Epilim tablets may be given twice daily. Tablets should be swallowed whole and not crushed or chewed. In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other Epilim conventional or prolonged release formulations on an equivalent daily dosage basis. DOSAGE Usual requirements are as follows: _ADULTS_ Dosage should start at 600mg daily increasing by 200mg at three-day intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day, i.e. 20-30mg/kg/day body weight. Where adequate control is not achieved within this range the dose may be further increased to 2500mg per day. _CHILDREN OVER 20KG_ Initial dosage should be 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 20-30mg/kg body weight per day. Where adequate control is not achieved within this body range the dose may be increased to 35mg/kg body weight per day. _CHILDREN UNDER 20KG_ 20mg/kg of body weight per day; Přečtěte si celý dokument