STEMETIL Solution for injection Ref.[27713] Active ingredients: Prochlorperazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Stemetil 12.5 mg/ml Injection.

Pharmaceutical Form

Colourless sterile solution.

Qualitative and quantitative composition

Each 1 ml of Stemetil injection contains 12.5 mg prochlorperazine mesilate.

Excipients:

Each 1 ml of Stemetil injection contains 1 mg of sodium sulphite, 0.75 mg of sodium metabisulphite and 6 mg of sodium chloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Prochlorperazine

Prochlorperazine belongs to the phenothiazine group. Prochlorperazine has a wide range of activity arising from its depressant actions on the CNS and its alpha-adrenergic blocking and weaker anti-muscarinic properties. It inhibits dopamine and prolactin-release-inhibitory factor, thus stimulating the release of prolactin.

List of Excipients

Sodium sulphite anhydrous (E221)
Sodium metabisulphite powder (E223)
Sodium chloride
Ethanolamine
Water for injections (non-sterilised)

Pack sizes and marketing

Stemetil injection is supplied in colourless glass ampoules in packs of 10 × 1 ml and 10 × 2 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as

Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0590

Date of first authorisation: 28 February 1973
Date of latest renewal: 16 September 2002

Drugs

Drug Countries
STEMETIL Australia, Cyprus, Estonia, Finland, Hong Kong, Ireland, Malta, New Zealand, Singapore, United Kingdom

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