OXYTOCIN Concentrate for solution for infusion Ref.[8470] Active ingredients: Oxytocin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Product name and form

Oxytocin 10 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 10 IU/ml.

Excipient(s) with known effect: None.

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
Glacial acetic acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

Clear, Type I, neutral glass, 1ml ampoules. Boxes of 10 or 5 ampoules. Not all packs sizes may be marketed.

Marketing authorization holder

Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Marketing authorization dates and numbers

PL 29831/0625

20/05/2014

Drugs

Drug Countries
OXYTOCIN Finland, Nigeria

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