Levetiracetam (Max Health)

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Levetiracetam 500mg;  

Tilgjengelig fra:

Max Health Limited

Dosering :

500 mg

Legemiddelform:

Film coated tablet

Sammensetning:

Active: Levetiracetam 500mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Maize starch Microcrystalline cellulose Opadry yellow AMB 84F82508 Povidone Purified talc

Resept typen:

Prescription

Indikasjoner:

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).

Produkt oppsummering:

Package - Contents - Shelf Life: Blister pack, clear PVC/Aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Autorisasjon dato:

2020-08-17

Preparatomtale

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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