DOPAMINE HYDROCHLORIDE Concentrate for solution for infusion Ref.[7833] Active ingredients: Dopamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Product name and form

Dopamine Hydrochloride 40mg/ml Concentrate for Solution for Infusion.

Pharmaceutical Form

Concentrate for solution for infusion.

Clear, colourless or pale yellow solution.

Qualitative and quantitative composition

Each ml contains 40 mg dopamine hydrochloride.

Each 5 ml ampoule contains 200mg Dopamine hydrochloride

Excipient(s) with known effect:

Each 5mL ampoule contains 50 mg sodium metabisulfite.

Each 5mL ampoule contains less than 1 mmol sodium (23 mg) that is to say essentially “sodium-free”.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Dopamine

Dopamine exerts positive inotropic and chronotropic effects on the myocardium, acting as an agonist at beta-adrenergic receptors. Depending on the vascular bed being studied and the dose administered, dopamine can cause relaxation or contraction of vascular smooth muscle.

List of Excipients

Sodium metabisulfite
Water for injections

Pack sizes and marketing

5 ml clear glass one point-cut (OPC) ampoules, glass Type I Ph Eur. borosilicate glass ampoules packed in cardboard cartons to contain 10 × 5ml ampoules.

Marketing authorization holder

Mercury Pharma International Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland

Marketing authorization dates and numbers

PL 02848/0130

14 September 1989 / 19 March 2008

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