국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
ACCORD HEALTHCARE SDN.BHD.
LEVETIRACETAM
10 x 10’s Tablets; 6 x 10’s Tablets
INTAS PHARMACEUTICALS LIMITED
Consumer Medication Information Leaflet (RiMUP) LEVERA (LEVETIRACETAM TABLETS) Levetiracetam (250mg, 500mg, 1000mg) 1 What is in this leaflet 1. What Levera tablets are used for 2. How Levera tablets work 3. Before you use Levera tablets 4. How to use Levera tablets 5. While you are using Levera tablets 6. Side effects 7. Storage and disposal of Levera tablets 8. Product description 9. Manufacturer and product registration holder 10. Date of revision What Levera tablets are used for Levera tablets are used on its own in adults and adolescents from 16 years of age with a certain type of newly diagnosed epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizures with or without secondary generalization). Levera tablets have been given to you by your doctor to reduce the number of fits. Levera tablets are used as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy. myoclonic seizures (short, shock- like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy primary generalized tonic-clonic seizures (major fits, including loss of consciousness) in adults and children from 12 years of age with Idiopathic Generalized Epilepsy. How Levera tablets work Levera tablets belong to a group called antiepileptic medicines. These medicines help reduce the occurrence of seizures in epilepsy. Before you use Levera tablets - When you must not take it Do not take Levera tablets if: You are allergic (hypersensitive) to Levetiracetam or any of the other ingredients of this medicine (see Product description). Pregnancy and breastfeeding: If you are pregnant or breastfeeding, think you may be pregnant or are planning to 전체 문서 읽기
FRONT SIDE BACK SIDE INP113 RLEV03I2044 PACKAGE INSERT LEVERA 250, 500 & 1000 (LEVETIRACETAM TABLETS 250 MG, 500 MG & 1000 MG) NAME AND STRENGTH OF ACTIVE INGREDIENT LEVERA 250 Levetiracetam Ph. Eur. 250 mg LEVERA 500 Levetiracetam Ph. Eur. 500 mg LEVERA 1000 Levetiracetam Ph. Eur. 1000 mg PRODUCT DESCRIPTION LEVERA 250 White to off white, oval, biconvex, film coated tablets debossed ‘L 64’ and breakline on one side and plain on other side. LEVERA 500 Yellow coloured, oval, biconvex, film coated tablets debossed ‘L 65’ and breakline on one side and plain on other side. LEVERA 1000 White to off white, oval, biconvex, film coated tablets debossed ‘L 67’ and breakline on one side and plain on other side. PHARMACOLOGICAL PROPERTIES PHARMACODYNAMIC PROPERTIES Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX14. The active substance, Levetiracetam, is a pyrrolidone derivative (S-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide), chemically unrelated to existing antiepileptic active substances. Mechanism of action The mechanism of action of Levetiracetam still remains to be fully elucidated. Levetiracetam does not alter basic cell characteristics and normal neurotransmission. Levetiracetam affects intraneuronal Ca 2+ levels by partial inhibition of N-type Ca 2+ currents and by reducing the release of Ca 2+ from intraneuronal stores. In addition it partially reverses the reductions in GABA- and glycine-gated currents induced by zinc and β-carbolines. Furthermore, Levetiracetam has been shown to bind to a specific site in rodent brain tissue. This binding site is the synaptic vesicle protein 2A, believed to be involved in vesicle fusion and neurotransmitter exocytosis. Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy. This finding suggests that the interaction between Levetiracetam and the synaptic vesicle 전체 문서 읽기