SYNTOCINON Concentrate for solution for infusion Ref.[27701] Active ingredients: Oxytocin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Syntocinon 5 IU/ml Concentrate for solution for infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

A clear, colourless, sterile solution in 1ml clear glass ampoules.

Qualitative and quantitative composition

Oxytocin.

Concentrate for solution for infusion (in 1mL ampoule) containing 5 IU/mL.

Excipient(s) with known effect:

Ethanol 96% - 5.0 mg/ml (equivalent to 4.7 mg/ml).

For the full list of excipients, see section 6.1.

Active Ingredient Description
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 acetate tri-hydrate
Acetic acid
Chlorobutanol
Ethanol
Water for injections

Pack sizes and marketing

Clear glass 1 ml ampoules. Boxes of 5 ampoules.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0062

25/06/1998

Drugs

Drug Countries
SYNTOCINON Austria, Brazil, Cyprus, Spain, Finland, France, Hong Kong, Croatia, Ireland, Malta, Mexico, Netherlands, Singapore, United Kingdom, South Africa

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