AURO-LEVETIRACETAM 1000 levetiracetam 1000 mg tablets Blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
28-11-2017

Aktivna sestavina:

levetiracetam, Quantity: 1000 mg

Dostopno od:

Strides Pharma Science Pty Ltd

INN (mednarodno ime):

Levetiracetam

Farmacevtska oblika:

Tablet, film coated

Sestava:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; povidone; purified talc; maize starch; titanium dioxide; hypromellose; macrogol 400

Pot uporabe:

Oral

Enote v paketu:

60

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

It is 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).

Povzetek izdelek:

Visual Identification: White, modified oval shaped, biconvex film-coated tablets debossed with a deep break line separating 'E' & '13' on one side & plain on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

2011-12-23