国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LEVETIRACETAM
UNIMED SDN BHD
LEVETIRACETAM
1 x 150ML Units; 300ML Units
Hetero Labs Limited
LETRAM (LEVETIRACETAM ) (Levetiracetam Oral Solution) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What LETRAM is used for 2. How LETRAM works 3. Before you use LETRAM 4. How to take LETRAM 5. While you are using LETRAM 6. Side effects 7. Storage and Disposal of LETRAM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LETRAM IS USED FOR LETRAM is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy. LETRAM is indicated as adjuctive theraphy: • In the treatment of seizures in adults and children from 4 years of age with epilepsy. • In the treatment of myoclonic seizures in adults and adolscents from 12 years of age with Juvenile Myoclonic Epilepsy. • In the treatment of primary generalized tonic-clonic seizures in adults and children from 12 years of age with Idiopathic Generalized Epilepsy. HOW LETRAM_ _WORKS LETRAM is an anti-epileptic medicine (a medicine used to treat seizures in epilepsy). BEFORE YOU USE LETRAM _When you must not use it_ _ _ Do not take LETRAM : • If you are allergic (hypersensitive) to LETRAM _ _ or any of the other ingredients of LETRAM. PREGNANCY AND LACTATION Pregnancy Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or if you think you may be pregnant, please inform your doctor. LETRAM _ _ should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. LETRAM _ _ has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures. Breastfeeding Breast-feeding is not recommended during treatment. - _Before you start use it_ Take special care with LETRAM and check with your doctor or pharmacist before using this medicine if you are suffering or have ever suffered from any of the following conditions or illnesses: • If you suffer from kidne 完全なドキュメントを読む
LETRAM OS LEVETIRACETAM ORAL SOLUTION 100MG/ML DESCRIPTION LETRAM OS (LEVETIRACETAM ORAL SOLUTION 100MG/ML) 150ML PACK SIZE: A Clear, colourless grape flavoured liquid filled in 200mL amber coloured glass bottle. LETRAM OS (LEVETIRACETAM ORAL SOLUTION 100MG/ML) 300ML PACK SIZE: A clear, colorless grape flavoured liquid filled in 300ml amber coloured glass bottle with EPE wad. Each ml contains 100.00mg of Levetiracetam, 1.500mg of Methyl Parahydroxy Benzoate (as preservative) and 0.180mg of Propyl Parahydroxy Benzoate (as preservative). PHARMACODYNAMICS 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 but appears to be different from the mechanisms of current antiepileptic medicinal products. _Pharmacodynamics effects _ Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalized seizures without having pro-convulsant effect. The primary metabolite is inactive. In man, activity in both partial and generalized epilepsy conditions (epileptiform discharge/photo paroxysmal response) has confirmed the broad spectrum of the preclinical pharmacological profile. PHARMACOKINETICS Levetiracetam is a highly soluble and permeable compound. The pharmacokinetic profile is linear and time-independent with low intra- and inter-subject variability. There is no modification of the clearance after repeated administration. There is no evidence for any relevant gender, race or circadian variability. The pharmacokinetic profile is comparable in healthy volunteers and in patients with epilepsy. Due to its complete and linear absorption, plasma levels can be predicted from the oral dose of levetiracetam expressed as mg/kg bodyweight. Therefore there is no need for plasma level monitoring of levetiracetam. A significant correlation between saliva and pla 完全なドキュメントを読む