국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
LABORATORIES TORRENT (MALAYSIA) SDN. BHD.
LEVETIRACETAM
10Tablet Tablets; 60Tablet Tablets; 100Tablet Tablets
TORRENT PHARMACEUTICALS LTD.
TORLEVA TABLET _ _ Levetiracetam (500mg, 1000mg) _ _ _ _ 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What is Torleva used for 2. How Torleva works 3. Before you use Torleva 4. How to use Torleva 5. While you are using it 6. Side effects 7. Storage and Disposal of Torleva 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TORLEVA IS USED FOR Torleva is used: • On its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat partial onset seizures with or without secondary generalisation. • As an add-on to other antiepileptic medicines to treat: Partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age. Myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy. Primary generalised tonic- clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy. HOW TORLEVA WORKS Torleva is used to control epilepsy. Epilepsy is a condition where you have repeated seizures. There are many different types of seizures, ranging from mild to severe. This medicine belongs to a group of medicines called anti-epileptics. These medicines are thought to work by controlling brain chemicals which send signals to nerves so that seizures do not happen. - _When you must not use it _ Do not take Torleva if: • You are allergic (hypersensitive) to levetiracetam or any of the other ingredients. • Pregnant or trying to get pregnant or think you may be pregnant. • Breastfeeding. _Pregnancy and lactation _ _ _ _ _ Do not take Torleva if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Torleva if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it _ Talk to your doctor before taking Torleva: • If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide i 전체 문서 읽기
Oral administration to pregnant rats during the period of organogenesis resulted in reduced fetal weight and increased incidence of embryofetal mortality and increased incidence of fetal skeletal variations at a dose of 3600mg/kg/day (11 times the maximal human dose on a mg/m 2 basis). The developmental no-effect dose was 1200mg/kg/day (4 times the maximal human dose on a mg/m 2 basis). There was no overt maternal toxicity. Oral administration to pregnant mice during the period of organogenesis did not produce teratogenic or embryotoxic effects at doses up to 3000mg/kg/day. This dose corresponds to approximately 5 times the maximal human dose on a mg/m 2 basis. Oral administration to rats during the late gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800mg/kg/day (6 times the maximal human dose on a mg/m 2 basis). To date, no clinical data on exposed pregnancies are available. TORLEVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. USE IN LACTATION Levetiracetam and/or its metabolites are excreted in milk in lactating rats; peak milk concentrations occurred 3 hours after oral administration (milk: plasma ratio 0.9). Levetiracetam is excreted in breast milk. Because of the potential for serious adverse reactions in breastfeeding infants from TORLEVA, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. INTERACTIONS WITH OTHER DRUGS _In vitro_, levetiracetam and its major metabolite (ucb L057) have been shown not to inhibit the major human liver cytochrome P450 isoforms, glucuronyl transferase, (valproic acid) and epoxide hydroxylase activities. In human hepatocytes in culture, levetiracetam did not cause enzyme induction. The interaction of TORLEVA with other drugs, or vice versa, is considered unlikely. Probenecid has been shown to inhibit the renal clearance of the major metabolite (ucb L057) but not 전체 문서 읽기