Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
VALPROATE SODIUM VALPROIC ACID
Sanofi-Aventis Ireland Limited
1000 Milligram
Granules Prolonged Release
2007-03-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epilim Chronosphere 1000mg prolonged-release granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet of prolonged-release granules contains: Sodium valproate 666.60 mg Valproic acid 290.27 mg Equivalent to 1000 mg sodium valproate. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release granules. Sachets containing small, off-white to slightly yellow, waxy microgranules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of generalised, partial or other epilepsy. Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to Epilim Chronosphere for acute mania. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epilim Chronosphere is a pharmaceutical form particularly suitable for children (when they are able to swallow soft food) and adults with swallowing difficulties. Epilim Chronosphere is a controlled release formulation of Epilim, which reduces peak concentration and ensures more regular plasma concentration throughout the day. Epilim Chronosphere may be given once or twice daily. In patients where adequate control has been achieved, Epilim Chronosphere formulations are interchangeable with other conventional or prolonged-release formulations of Epilim on an equivalent daily dosage basis. Daily dosage should be established according to age and body weight and should be given to the nearest whole 50mg sachet. Partial sachets should not be used.. However, the wide individual sensitivity to valproate should also be considered. A good correlation has not been established between daily dose, serum concentration and therapeutic effect, and optimum dosage should be determ Lees het volledige document