Admed Levetiracetam

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Levetiracetam 1000mg;  

Dostupné s:

AdiraMedica Pty Ltd.

Dávkování:

1000 mg

Léková forma:

Film coated tablet

Složení:

Active: Levetiracetam 1000mg   Excipient: Copovidone Croscarmellose sodium Magnesium stearate Opadry Clear OY-29020 Opadry white 85F18422 Pregelatinised maize starch Purified talc Purified water

Druh předpisu:

Prescription

Terapeutické indikace:

Use in epileptic patients aged 6 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 generalized tonic-clonic seizures in adults and children from 6 years of age with idiopathic generalized epilepsy (IGE).

Přehled produktů:

Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Aluminium in cardboard carton - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Datum autorizace:

2019-03-14

Charakteristika produktu

AdMed Levetiracetam Tablets version: 3.0
Page 1 of 30
NEW ZEALAND DATA SHEET
ADMED LEVETIRACETAM (LEVETIRACETAM) FILM-COATED TABLETS
CONTAINING 250 MG, 500 MG, 750 MG OR 1000 MG LEVETIRACETAM PER
TABLET.
1
PRODUCT NAME (STRENGTH, PHARMACEUTICAL FORM)
AdMed Levetiracetam film coated tablets containing 250 mg, 500mg, 750
mg or 1000 mg levetiracetam
per tablet.
2
QUALITATIVE AND QUANTITATIVECOMPOSITION
AdMed Levetiracetam film-coated tablets are available in strengths of
250 mg, 500 mg, 750
mg and 1000 mg levetiracetam.
It does not contain any excipient with known affect. For the full list
of excipients, see
Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Levetiracetam film coated tablets are available in four different
strengths with the following
descriptions:
250 mg: Blue Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect“250”
on one side and plain on other side.
500 mg: Yellow Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect “500”
on one side and plain on other side.
750 mg: Orange Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect
“750” on one side and plain on other side.
1000 mg: White Coloured, ‘Oval’ shaped, film coated tablets,
embossed with “OL” bisect
“1000” on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Levetiracetam is indicated for:
•
use in epileptic patients aged 6 years and older, initially as add-on
therapy, inthe
treatment of partial onset seizures with or without
secondarygeneralisation;
•
monotherapy in the treatment of partial onset seizures, with or
without secondary
AdMed Levetiracetam Tablets version: 3.0
Page 2 of 30
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 generalized tonic-clonic
seizures inadul