SYNACTHEN DEPOT Suspension for injection Ref.[8607] Active ingredients: Tetracosactide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Atnahs Pharma UK Ltd., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK

Product name and form

Synacthen Depot Ampoules 1mg/ml.

Pharmaceutical Form

Suspension for injection.

Tetracosactide acetate is absorbed on to zinc phosphate. A sterile, milky white suspension, which settles on standing, in a clear glass ampoule.

Qualitative and quantitative composition

Tetracosactide acetate 1mg/ml.

Excipient(s) with known effect:

Contains benzyl alcohol (10mg/ml).

Each ampoule contains a total of 3.32 mg of sodium.

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

Zinc chloride anhydrous pure
Disodium phosphate dodecahydrate
Benzyl alcohol
Sodium chloride
Sodium hydroxide
Water for injections

Pack sizes and marketing

Synacthen Depot comes in cardboard boxes of 1 ampoule and 10 ampoules.

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 43252/0027

25 June 1998

Drugs

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

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