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左乙拉西坦注射液EMEA说明书
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
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.
Excipients:
Each vial contains 57 mg of sodium (11.4 mg/ml).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear, colourless concentrate.
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 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 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
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 depend
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