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XOMOLIX Solution for injection (2018)

Active ingredients: Droperidol

Product Name and Form

Xomolix 2.5 mg/ml solution for injection.

Pharmaceutical form

Solution for injection.

Clear colourless solution, free from visible particles.

The pH of droperidol solution for injection is 3.0-3.8 and has an osmolarity of approximately 300 milliosmol/kg water.

Qualitative and Quantitative Composition

Each millilitre of the solution contains 2.5 mg droperidol.

Excipient: sodium <23 mg per ml (see section 4.4 for further details).

For a full list of excipients, see section 6.1.

Chemical substance
Description
Droperidol

Droperidol is a butyrophenone neuroleptic. Its pharmacologic profile is characterised mainly by dopamine-blocking and weak α1-adrenolytic effects. Droperidol is devoid of anticholinergic and antihistaminic activity.

List of excipients

Mannitol
Tartaric acid
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and Marketing

Type I amber glass ampoules containing 1 ml solution for injection, in packs of 10 ampoules.

Marketing authorization holder
Authorization dates

Kyowa Kirin Ltd, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom, Tel. +44 (0)1896 664000

28.01.2008

Marketing authorization number:

PL 16508/0036