OFOST Solution for injection/infusion Ref.[50401] Active ingredients: Oxytocin

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: AS Grindeks, Krustpils Iela 53, Riga, 1057, Latvia

Product name and form

Ofost 5 IU/ml concentrate for solution for infusion or solution for intramuscular injection.

Pharmaceutical Form
Solution for injection/infusion (Injection/Infusion). Colourless, clear liquid, free from visible particles. pH of solutions 3.5-4.5.

Qualitative and quantitative composition

1 ml of solution contains 8.3 microgram oxytocin (5 IU).

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
Chlorobutanol hemihydrate Acetic acid (pH-adjustment) Water for injections

Pack sizes and marketing

1 ml transparent type I borosilicate glass ampoules with break ring or open point cut.

Pack sizes: 5, 10 or 100 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

AS Grindeks, Krustpils Iela 53, Riga, 1057, Latvia

Marketing authorization dates and numbers

PA22992/001/001

Date of first authorisation: 11^th December 2020
Date of last renewal: 21^st June 2022

Drugs

Drug	Countries
OFOST	Ireland, Lithuania, Romania

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