Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
levetiracetam
Sun Pharmaceutical Industries Europe B.V.
N03AX14
levetiracetam
Other antiepileptics
Epilepsy
Levetiracetam Sun is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy.Levetiracetam Sun is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy;in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy;in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy.Levetiracetam Sun concentrate is an alternative for patients when oral administration is temporarily not feasible.
Revision: 19
Authorised
2011-12-14
25 B. PACKAGE LEAFLET 26 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LEVETIRACETAM SUN 100 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION levetiracetam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or nurse. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Levetiracetam SUN is and what it is used for 2. What you need to know before you are given Levetiracetam SUN 3. How Levetiracetam SUN is given 4. Possible side effects 5. How to store Levetiracetam SUN 6. Contents of the pack and other information 1. WHAT LEVETIRACETAM SUN IS AND WHAT IS IT USED FOR Levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). Levetiracetam SUN is used - on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of 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 seizure with or without secondary generalisation). Levetiracetam has been given to you by your doctor to reduce the number of fits - with other antiepileptic medicines (add-on therapy) to treat: - partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age - 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 generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam SUN 100 mg/ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 mg of levetiracetam. Each 5 ml vial contains 500 mg of levetiracetam. Excipient with known effect Each vial contains 19 mg of sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam SUN is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam SUN is indicated as adjunctive therapy - in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy - in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy - in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam SUN concentrate is an alternative for patients when oral administration is temporarily not feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Levetiracetam therapy can be initiated with either intravenous or oral administration. Conversion to or from oral to intravenous administration can be done directly without titration. The total daily dose and frequency of administration should be maintained. _Partial onset seizures _ The recommended dosing for monotherapy (from 16 years of age) and adjunctive therapy is the same; as outlined below. _ _ _All indications _ 3 _Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more_ The initial therapeutic dose is 500 mg twice daily. This dose can be started on the first day of treatment. However, a lower initial Pročitajte cijeli dokument