KETALAR Solution for injection or infusion Ref.[7961] Active ingredients: Ketamine

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

Product name and form

Ketalar 10 mg/ml Injection.

Pharmaceutical Form

Solution for Injection or Infusion.

A clear solution for injection or infusion.

Qualitative and quantitative composition

Each 1 ml of solution contains: ketamine hydrochloride equivalent to 10 mg ketamine base per ml.

Excipient(s) with known effect: Each 1 ml contains 2.6 mg of sodium.

For the full list of excipients see section 6.1.

Active Ingredient Description
Ketamine

Ketamine is a rapidly acting general anaesthetic for intravenous or intramuscular use with a distinct pharmacological action. Ketamine hydrochloride produces dissociative anaesthesia characterised by catalepsy, amnesia, and marked analgesia which may persist into the recovery period.

List of Excipients

Sodium chloride
Benzethonium chloride
Water for injections

Pack sizes and marketing

20 ml white neutral glass vial with rubber closure and aluminium flip-off cap containing 20ml of solution as 10 mg ketamine base per ml.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0529

1st July 2003

Drugs

Drug Countries
KETALAR Canada, Finland, Hong Kong, Ireland, Japan, New Zealand, Poland, Turkey, United Kingdom, United States

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