HAEMOPRESSIN Powder and solvent for solution for injection Ref.[49850] Active ingredients: Terlipressin

Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Alliance Pharma (Ireland) Limited, United Drug Distributors, United Drug House, Magna Business Park, Magna Drive, Citywest, Dublin 24, Ireland

Product name and form

Haemopressin 1 mg powder and solvent for solution for injection.

Pharmaceutical Form
Powder and solvent for solution for injection White to off white solid powder and a clear colourless solution

Qualitative and quantitative composition

Each vial of powder contains:

1 mg terlipressin acetate equivalent to 0.85 mg terlipressin.

1 ml of reconstituted solution contains 0.2 mg terlipressin acetate.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Terlipressin	Terlipressin inhibits portal hypertension with simultaneous reduction of blood circulation in portal vessels. Terlipressin contracts smooth oesophageal muscle with consecutive compression of oesophageal varices.

List of Excipients
Each vial of powder contains: Mannitol Acetic acid (for pH adjustments) Each solvent ampoule contains: Sodium chloride Water for injections

Pack sizes and marketing

Powder:

Colourless, type I glass vials, closed with bromobutyl rubber stopper and sealed with aluminium flip-off cap. Each vial contains 11 mg powder.

Solvent:

Colourless, type I glass ampoules, sealed by fusion. Each ampoule contains 5 ml solvent.

Pack sizes:

1 vial with powder and 1 ampoule of solvent.

5 vials with powder and 5 ampoules of solvent.

Not all pack sizes may be marketed.

Marketing authorization holder

Alliance Pharma (Ireland) Limited, United Drug Distributors, United Drug House, Magna Business Park, Magna Drive, Citywest, Dublin 24, Ireland

Marketing authorization dates and numbers

PA2325/004/001

Date of first authorisation: 1^st May 2009
Date of last renewal: 7^th June 2011

Drugs

Drug	Countries
HAEMOPRESSIN	Austria, France, Ireland

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