Land: Malta
Språk: engelska
Källa: Medicines Authority
LEVETIRACETAM
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
N03AX14
LEVETIRACETAM 100 mg/ml
CONCENTRATE FOR SOLUTION FOR INFUSION
LEVETIRACETAM 100 mg/ml
POM
ANTIEPILEPTICS
Withdrawn
2012-03-12
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
LEVETIRACETAM FAIR-MED HEALTHCARE 100 MG/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
Levetiracetam
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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam Fair-Med Healthcare 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 Excipients: Each dose contains 19.1 mg of sodium For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless, concentrate 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam Fair-Med Healthcare 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 Fair-Med Healthcare is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults 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 Fair-Med Healthcare concentrate is an alternative for patients when oral administration is temporarily not feasible. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Monotherapy for adults and adolescents from 16 years of age _ The recommended starting dose is 250 mg twice daily which should be increased to an initial therapeutic dose of 500 mg twice daily after two weeks. The dose can be further increased by 250 mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500 mg twice daily. _Add-on therapy for Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more _ The initi Läs hela dokumentet