HYDRALAZINE Powder for concentrate for solution for injection/infusion Ref.[8220] Active ingredients: Hydralazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Product name and form

Apresoline Ampoules 20 mg.

Hydralazine 20mg Powder for Concentrate for Solution for Injection/Infusion.

Pharmaceutical Form

Ampoules containing powder for concentrate for solution for injection/infusion.

White to yellow lyophilisate (pellet).

Qualitative and quantitative composition

The active ingredient is 1-hydralainophthalazine hydrochloride (hydralazine hydrochloride). Each 2 ml ampoule contains 20mg hydralazine hydrochloride.

Excipient(s) with Known effect: For the full list of excipients, see section 6.1.

Active Ingredient Description
Hydralazine

Hydralazine is a direct acting vasodilator which exerts its effects principally on the arterioles. Its precise mode of action is not known.

List of Excipients

Hydrochloric acid

Pack sizes and marketing

Colourless Type I glass 2ml ampoule. Five ampoules are packed in a cardboard printed carton.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20072/0230

15 November 2001

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