Krajina: Švédsko
Jazyk: švédčina
Zdroj: Läkemedelsverket (Medical Products Agency)
levetiracetam
Alfred E Tiefenbacher (GmbH & Co. KG)
N03AX14
levetiracetam
500 mg
Filmdragerad tablett
levetiracetam 500 mg Aktiv substans
Receptbelagt
Levetiracetam
Avregistrerad
2012-04-12
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Levetiracetam Tiefenbacher 250 mg film-coated tablets. Levetiracetam Tiefenbacher 500 mg film-coated tablets. Levetiracetam Tiefenbacher 750 mg film-coated tablets. Levetiracetam Tiefenbacher 1000 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Levetiracetam Tiefenbacher 250 mg film-coated tablets_ Each film-coated tablet contains 250 mg levetiracetam. _Levetiracetam Tiefenbacher 500 mg film-coated tablets_ Each film-coated tablet contains 500 mg levetiracetam. _Levetiracetam Tiefenbacher 750 mg film-coated tablets_ Each film-coated tablet contains 750 mg levetiracetam. Excipient with known effect: Each film-coated tablet contains 0.17 mg of sunset yellow FCF (E110). _Levetiracetam Tiefenbacher 1000 mg film-coated tablets_ Each film-coated tablet contains 1000 mg levetiracetam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. _Levetiracetam Tiefenbacher 250 mg film-coated tablets_ Blue coloured, capsule shaped tablets (12,7 x 5,9 mm) with deep notch on one side. The tablets can be divided into equal halves. _Levetiracetam Tiefenbacher 500 mg film-coated tablets_ Yellow coloured, capsule shaped tablets (16,3 x 7,6 mm)with deep notch on one side. The tablets can be divided into equal halves. _Levetiracetam Tiefenbacher 750 mg film-coated tablets_ Orange coloured, capsule shaped tablets (18,6 x 8,65 mm) with deep notch on one side. The tablets can be divided into equal halves. _Levetiracetam Tiefenbacher 1000 mg film-coated tablets_ White coloured, capsule shaped tablets (19,1 x 10,2 mm) with deep notch on one side. The tablets can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Levetiracetam Tiefenbacher 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 Tiefenbacher is indicated as adjunctive therapy Prečítajte si celý dokument