DOBUTAMINE Solution for infusion

Active ingredients: Dobutamine

Product name and form

Dobutamine 5 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

The product is a clear, colourless or almost colourless solution.

Qualitative and quantitative composition

Each ampoule/vial Dobutamine contains dobutamine hydrochloride corresponding to 250 mg dobutamine.

50 ml ampoule/vial

1 ml contains 5 mg dobutamine.

Excipient with known effect: This medicine contains less than 1mmol sodium (23 mg) per 1 ml, that is to say essentially “sodium-free”.

For a full list of excipients, see section 6.1.

Active Ingredient

Dobutamine is a synthetic, sympathomimetic amine, structurally related to isoproterenol and dopamine, and is administered as racemate. The positive inotropic effect is primarily based on the agonistic effect on cardiac beta1-receptors but also on cardiac alpha1-receptors.

List of Excipients

Sodium metabisulfite (E223)
Sodium chloride
Hydrochloric acid
Water for injections

Pack sizes and marketing

Dobutamine 5 mg/ml (250 mg in 50 ml) ampoules made of colourless, neutral glass, type I Ph.Eur.

1, 5 and 10 ampoules with 50 ml solution for infusion.

Dobutamine 5 mg/ml (250 mg in 50 ml) vials made of colourless, neutral glass, type I Ph. Eur, with rubber stopper, Ph.Eur.

1, 5, 10 and 20 vials with 50 ml solution for infusion.

Not all pack sizes may be marketed.

Marketing authorization holder

Hameln pharma plus gmbh,Langes Feld 13,31789 Hameln, Germany

Marketing authorization dates and numbers

PL 25215/0004

13/02/2006 / 13/02/2011