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

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Mercury Pharmaceuticals Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom

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.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Dopamine	Dopamine hydrochloride stimulates adrenergic receptors of the sympathetic nervous system. Dopamine hydrochloride has principally a direct stimulatory effect on β1-adrenergic receptors, but also appears to have an indirect effect by releasing norepinephrine from its storage sites. Dopamine hydrochloride also appears to act on specific dopaminergic receptors in the renal, mesenteric, coronary, and intracerebral vascular beds to cause vasodilation.

List of Excipients
Sodium metabisulfite (E223) 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 Pharmaceuticals Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom

Marketing authorization dates and numbers

PL 12762/0571

Date of first authorisation: 14 September 1989
Date of latest renewal: 19 March 2008

Drugs

Drug	Countries
DOPAMINE	Nigeria

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