KEPPRA Concentrate for solution for infusion Ref.[7436] Active ingredients: Levetiracetam

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Product name and form

Keppra 100 mg/ml concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion (sterile concentrate).

Clear, colourless, liquid.

Qualitative and quantitative composition

Each ml contains 100 mg of levetiracetam.

Each 5 ml vial contains 500 mg of levetiracetam.

Excipient with known effect: Each vial contains 19 mg of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Levetiracetam

Levetiracetam, is a pyrrolidone derivative, chemically unrelated to existing antiepileptic active substances. Levetiracetam induces seizure protection in a broad range of animal models of partial and primary generalised seizures without having a pro-convulsant effect. The primary metabolite is inactive.

List of Excipients

Sodium acetate
Glacial acetic acid
Sodium chloride
Water for injections

Pack sizes and marketing

5 ml glass vial (type I) closed by a polytetrafluoroethylene grey chlorobutyl rubber stopper or an uncoated grey bromobutyl rubber stopper and sealed with an aluminium/polypropylene flip cap.

Each carton contains 10 vials.

Marketing authorization holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium

Marketing authorization dates and numbers

EU/1/00/146/030
EU/1/00/146/033

Date of first authorisation: 29 September 2000
Date of latest renewal: 20 August 2015

Drugs

Drug Countries
KEPPRA Austria, Australia, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Nigeria, Netherlands, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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