LEVETIRACETAM-GA levetiracetam 250mg film coated tablet blister pack

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

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PAR PAR (PAR)
29-11-2017

active_ingredient:

levetiracetam, Quantity: 250 mg

MAH:

Medis Pharma Pty Ltd

INN:

Levetiracetam

pharmaceutical_form:

Tablet, film coated

composition:

Excipient Ingredients: titanium dioxide; magnesium stearate; macrogol 400; colloidal anhydrous silica; crospovidone; indigo carmine; hypromellose; purified talc; povidone

administration_route:

Oral

units_in_package:

60 tablets

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Levetiracetam film-coated 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), and ? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).

leaflet_short:

Visual Identification: Blue colour, oval shaped film coated tablets with break line on one side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

authorization_status:

Licence status A

authorization_date:

2012-04-17