ESMOLOL HYDROCHLORIDE Powder for concentrate solution Ref.[7954] Active ingredients: Esmolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002 Purkersdorf, Austria

Product name and form

ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion.

Pharmaceutical Form

Powder for concentrate for solution for infusion.

The powder is white to almost white.

Qualitative and quantitative composition

A vial of 50 ml contains 2500 mg esmolol hydrochloride.

Each ml of reconstituted concentrate for solution for infusion contains 50 mg esmolol hydrochloride (50 mg/ml).

Each ml of the diluted solution for infusion contains 10 mg esmolol hydrochloride (10 mg/ml).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Esmolol

Esmolol is a beta-selective (cardioselective) receptor blocking agent. At therapeutic doses esmolol has no significant intrinsic sympathicomimetic activity (ISA) or membrane stabilising activity.

List of Excipients

None.

Pack sizes and marketing

A clear, colourless, 50 ml glass vial with a bromobutyl rubber stopper and a flip off seal containing 2500 mg powder for concentrate for solution for infusion. The vial is packed in an outer cardboard carton.

Pack size: 1 vial per carton.

Marketing authorization holder

Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002 Purkersdorf, Austria

Marketing authorization dates and numbers

PL 30414/0008

Date of first authorisation: 04/10/2010

Drugs

Drug Countries
ESMOLOL Austria, United Kingdom

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