PETHIDINE Solution for injection Ref.[7724] Active ingredients: Pethidine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Pethidine Hydrochloride 50mg/ml Solution for Injection.

Pharmaceutical Form

Clear, colourless, sterile solution intended for parenteral administration to human beings.

Qualitative and quantitative composition

Each 1ml of solution contains 50mg of Pethidine Hydrochloride B.P..

Active Ingredient Description
Pethidine

Pethidine is a synthetic opioid analgesic similar with similar actions to morphine. Like other opioids, pethidine binds to opioid receptors and exerts its principal pharmacological actions on the central nervous system where its analgesic and sedative effects are of particular therapeutic value. Pethidine also causes the release of histamine from mast cells resulting in a number of allergic-type reactions.

List of Excipients

Sodium hydroxide B.P.
Dilute hydrochloric acid B.P.
Water for injections B.P.

Pack sizes and marketing

1ml and 2ml clear glass ampoules, glass type 1 Ph. Eur. packed in cardboard cartons to contain 10 × 1ml or 10 × 2ml ampoules.

Marketing authorization holder

Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 12762/0596

Date of first authorisation: 10/05/82
Date of renewal: 13/03/97

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