SYNACTHEN Solution for injection or infusion Ref.[27686] Active ingredients: Tetracosactide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Atnahs Pharma UK Ltd., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK

Product name and form

Synacthen Ampoules 250 mcg.

Pharmaceutical Form

Solution for injection or infusion.

A clear colourless aqueous solution for intramuscular injection or intravenous infusion in a 1 mL clear glass ampoule.

Qualitative and quantitative composition

Tetracosactide acetate 250 micrograms per ampoule.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tetracosactide

Tetracosactide acetate consists of the first 24 amino acids occurring in the natural corticotropic hormone (ACTH) sequence and displays the same physiological properties as ACTH. In the adrenal cortex, it stimulates the biosynthesis of glucocorticoids, mineralocorticoids, and, to a lesser extent, androgens, which explains its therapeutic effect in conditions responsive to glucocorticoid treatment.

List of Excipients

Acetic acid
Sodium acetate
Sodium chloride
Water for injection

Pack sizes and marketing

The ampoules are colourless glass Ph.Eur type I.

Synacthen Ampoules comes in cardboard boxes of 1 ampoule and 5 ampoules of 1 ml.

Not all pack sizes may be marketed.

Marketing authorization holder

Atnahs Pharma UK Ltd., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK

Marketing authorization dates and numbers

PL 43252/0026

25 June 1998

Drugs

Drug Countries
SYNACTHEN Australia, Estonia, Ireland, Lithuania, Malta, Netherlands, New Zealand, Turkey, United Kingdom

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