Χώρα: Μαλαισία
Γλώσσα: Αγγλικά
Πηγή: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM VALPROATE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
SODIUM VALPROATE
300ml1Units mL
Unither Liquid Manufacturing
_Consumer Medication Information Leaflet (RiMUP) _ 1 EPILIM ® SYRUP Sodium Valproate (200mg/5ml) WARNING Epilim, < Sodium Valproate > can seriously harm an unborn child when taken during pregnancy. If you are a female able to have a baby you must use at least one effective method of birth control (contraception) without interruption during your entire treatment with Epilim. Your doctor should discuss with you the most appropriate method of contraception for you. Schedule an urgent appointment with your doctor if you want to become pregnant or if you think you are pregnant. You must not stop taking Epilim unless your doctor tells you to as your condition may become worse. WHAT IS IN THIS LEAFLET 1. What Epilim is used for 2. How Epilim works 3. Before you use Epilim 4. How to use Epilim 5. While you are using it 6. Side effects 7. Storage and Disposal of Epilim 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT EPILIM IS USED FOR Epilim is used for the treatment of generalised (affects the entire brain) or partial (only affects a small part of the rain) epilepsy (fits) with the following pattern of seizures: - absence (a short period of “blanking out") - myoclonic (brief, shock-like jerks of muscles) - tonic-clonic (muscles stiffen, and jerking movements) - atonic (muscles suddenly lose strength) - mixed - simple (awareness is retained) or complex (impairment of awareness) seizures - secondary generalised seizures (spread to both sides of the brain after the initial event) - specific syndromes (Wes, Lennox- Gastaut) Epilim may also be used to control bipolar disorder, a mental condition with mania symptoms (an elevation of mood). HOW EPILIM WORKS Epilim contains a medicine called sodium valproate. This belongs to a group of medicines called anti- convulsants or anti-epileptic agents. It works by controlling brain chemicals which send signals to nerves so that seizures do not happen. BEFORE YOU USE EPILIM _ When you must not use it_ Bipolar disorder • For bipolar d Διαβάστε το πλήρες έγγραφο
1 NAME OF THE MEDICINAL PRODUCT EPILIM SYRUP/SODIUM VALPROATE 200MG QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of syrup contains Sodium Valproate 200mg. PHARMACEUTICAL FORM Syrup INDICATIONS Treatment of generalized or partial epilepsy, particularly with the following patterns of seizures: - Absence - Myoclonic - Tonic-clonic - Atonic - Mixed As well as, for partial epilepsy: - Simple or complex seizures - Secondary generalized seizures - Specific syndromes (West, Lennox-Gastaut) Treatment and prevention of mania associated with bipolar disorder. DOSAGE AND METHOD OF ADMINISTRATION Epilim Syrup is for oral administration. Daily dosage requirements vary according to age and body weight. Epilim Syrup may be given twice daily. If it is necessary to dilute Epilim Syrup, the recommended diluent is Syrup BP, but syrup containing SO 2 as a preservative should not be used. The diluted product will have a 14-day shelf life. In patients where adequate control has been achieved Epilim Chrono formulations are interchangeable with other conventional or prolonged release formulations on an equivalent daily dosage basis. _DOSAGE _ Usual requirements are as follows: _TREATMENT OF EPILEPSY_ 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, ie 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 range the dose may be increased to 35mg/kg body weight per day. Children under 20kg 20mg/kg of body weight per day; in severe cases this may be increased but only in patients in whom plasma valproic acid levels can be monitored. Above 40mg/kg/day, clinical chemistry and haematologi Διαβάστε το πλήρες έγγραφο