SYNTOMETRINE Solution for injection Ref.[28070] Active ingredients: Ergometrine Oxytocin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Product name and form

Syntometrine 500 micrograms/5 IU Solution for Injection.

Pharmaceutical Form

Solution for injection.

The solution is clear, colourless, faintly bluish fluorescent.

Qualitative and quantitative composition

Each 1ml ampoule contains 500 micrograms ergometrine maleate and 5IU oxytocin.

Excipient with known effect:

Sodium chloride 7.000 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ergometrine

Ergometrine produces sustained tonic uterine contraction via agonist or partial agonist effects at myometrial 5-HT2 receptors and alpha-adrenergic receptors. Both upper and lower uterine segments are stimulated to contract in a tetanic manner.

Oxytocin

Oxytocin is a cyclic nonapeptide that is obtained by chemical synthesis. This synthetic form is identical to the natural hormone that is stored in the posterior pituitary and released into the systemic circulation in response to suckling and labour.

List of Excipients

Sodium chloride
Maleic acid
Water for injections
Chlorobutanol
Sodium acetate trihydrate
Acetic acid

Pack sizes and marketing

Uncoloured borosilicate glass Type I snap ampoule. Packs of 5 ampoules.

Marketing authorization holder

Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB

Marketing authorization dates and numbers

PL16853/0021

25 June 1998

Drugs

Drug Countries
SYNTOMETRINE Hong Kong, Ireland, Malta, New Zealand, Singapore, United Kingdom, South Africa

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