EPANUTIN READY MIXED Solution for injection or infusion Ref.[7332] Active ingredients: Phenytoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

Product name and form

Epanutin Ready Mixed Parenteral 250 mg/5 ml Solution for Injection or Infusion.

Pharmaceutical Form

Solution for Injection or Infusion.

Clear, colourless, sterile solution.

Qualitative and quantitative composition

Each 5 ml ampoule contains phenytoin sodium 250 mg (50 mg/ml).

Excipients with known effect: Each 5 ml also contains 440.4 mg ethanol 96% and 24.6 mg of sodium.

For the full list of excipients see section 6.1.

Active Ingredient Description
Phenytoin

Phenytoin is effective in various animal models of generalised convulsive disorders, reasonably effective in models of partial seizures but relatively ineffective in models of myoclonic seizures. It appears to stabilise rather than raise the seizure threshold and prevents spread of seizure activity rather than abolish the primary focus of seizure discharge.

List of Excipients

Each 5 ml contains:

Propylene glycol
Ethanol 96%
Water for injection
Sodium hydroxide

Pack sizes and marketing

5 ml, colourless neutral glass, Type 1, Ph Eur, with a white colour break band. Each pack contains 10 ampoules.

Marketing authorization holder

Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0527

Date of latest renewal: 1st March 2004

Drugs

Drug Countries
EPANUTIN Austria, Cyprus, Spain, Ireland, Israel, Malta, Netherlands, Poland, Turkey, United Kingdom, South Africa

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