Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Levetiracetam 250mg;
Max Health Limited
250 mg
Film coated tablet
Active: Levetiracetam 250mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Maize starch Microcrystalline cellulose Opadry blue AMB 84F80803 Povidone Purified talc
Prescription
Indicated for: - use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation; - monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy; - add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy (JME); and - add-on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).
Package - Contents - Shelf Life: Blister pack, clear PVC/Aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 30°C
2020-08-17
Page 1 of 28 NEW ZEALAND DATASHEET 1 PRODUCT NAME OF THE MEDICINE Levetiracetam, 250 mg, 500 mg, 750 mg and 1000 mg film coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Levetiracetam 250 mg, 500 mg, 750 mg and 1000 mg film coated tablets. Excipients with known effect (750 mg only): Each film-coated tablet contains 0.13 mg of E110 Sunset yellow FCF. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets 250 mg: Blue, oblong-shaped, biconvex film coated tablets debossed with '250' on one side and score line on the other side. 500 mg: Yellow, oblong-shaped, biconvex film coated tablets debossed with '500' on one side and score line on the other side. 750 mg: Peach coloured, oblong-shaped, biconvex film coated tablets debossed with '750' on one side and score line on the other side. 1000 mg: White to off-white, oblong-shaped, biconvex film coated tablets debossed with '1000' on one side and score line on the other side. The tablets can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Levetiracetam tablets are indicated for: • use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation. • monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. • add-on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME). • add-on therapy in the treatment of primary generalised tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE). 4.2 Dose and method of administration Levetiracetam treatment can be given either through oral or intravenous administration. Converting from oral to intravenous or intravenous to oral administration does not require Page 2 of 28 titration, and in this case, the total dosage prescribed Les hele dokumentet