국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
LEVETIRACETAM
100 Tablets; 60 Tablets
UCB Pharma S.A.
Consumer Medication Information Leaflet (RiMUP) KEPPRA FILM COATED TABLET / ORAL SOLUTION Levetiracetam (250mg, 500mg, 1000mg, 100mg/ml) 1 What is in this leaflet 1. What KEPPRA is used for 2. How KEPPRA works 3. Before you use KEPPRA 4. How to use KEPPRA 5. While you are using it 6. Side effects 7. Storage and Disposal of KEPPRA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number What KEPPRA is used for Keppra is 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). Keppra has been given to you by your doctor to reduce the number of fits. • 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 KEPPRA works Keppra is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Before you use KEPPRA - When you must not use it Do not take Keppra • If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (see section Product Description). Pregnancy and breastfeeding: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Keppra can be used during pregnancy, only if a 전체 문서 읽기
Page 1 of 20 [GSK Logo] KEPPRA Levetiracetam NAME OF THE MEDICINAL PRODUCT Levetiracetam, 250 mg, film-coated tablet Levetiracetam, 500 mg, film-coated tablet Levetiracetam, 1000 mg, film-coated tablet Levetiracetam, 100 mg/ml, oral solution Levetiracetam, 100 mg/ml, concentrate for solution for infusion QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam, 250 mg, film-coated tablet Each film-coated tablet contains 250 mg of levetiracetam. Levetiracetam, 500 mg, film-coated tablet Each film-coated tablet contains 500 mg of levetiracetam. Levetiracetam, 1000 mg, film-coated tablet Each film-coated tablet contains 1000 mg of levetiracetam. Levetiracetam, 100 mg/ml, oral solution Each ml contains 100 mg of levetiracetam. Levetiracetam, 100 mg/ml, concentrate for solution for infusion Each ml contains 100 mg of levetiracetam. Excipients Levetiracetam, 250 mg, film-coated tablet Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Opadry 85F20694 Blue: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol/PEG 3350, Talc, FD&C blue #2/Indigo carmine aluminium lake (E132) Levetiracetam, 500 mg, film-coated tablet Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Opadry 85F32004 Yellow: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol/PEG 3350, Talc, Iron oxide yellow (E172) Levetiracetam, 1000 mg, film-coated tablet Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Opadry 85F18422 White: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol/PEG 3350, Talc Levetiracetam, 100 mg/ml, oral solution Sodium citrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol 85 per cent (E422), Page 2 of 20 Maltitol liquid (E965), Acesulfame potassium (E950), Grape flavor Firmenich 501040A, Purified water. Levetiracetam, 100 mg/ml, concentrate for solution for infusion Sodium acetate trihydrate, Glacial acetic acid, Sodium chloride, Water for injectio 전체 문서 읽기