GENRX LEVETIRACETAM IV levetiracetam 500mg/5mL concentrate solution for IV infusion vial

Active ingredient:

levetiracetam, Quantity: 100 mg/mL

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: sodium acetate trihydrate; sodium chloride; glacial acetic acid; water for injections

Administration route:

Intravenous Infusion

Units in package:

10 x 5mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Levetiracetam concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. 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).

Product summary:

Visual Identification: A clear, colourless, sterile solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-03-12