NALPAIN Solution for injection Ref.[8190] Active ingredients: Nalbuphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002, Purkersdorf, Austria

Product name and form

NALPAIN 10 mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

The solution is clear and colourless.

pH = 3.0-4.2, osmolarity = 0.3 Osmol/kg

Qualitative and quantitative composition

1 ml solution for injection contains 10 mg nalbuphine hydrochloride.

1 ampoule of 2 ml contains 20 mg nalbuphine hydrochloride.

Excipient: 1.6 mg sodium in a 2 ml ampoule.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Nalbuphine

Nalbuphine is an opioid with kappa-agonistic and mu-antagonistic properties. Beside the essential agonistic (analgesic) effect nalbuphine has antagonistic effects of about a fourth of nalorfine and ten times of pentazocine.

List of Excipients

Citric acid, anhydrous
Sodium citrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Water for injection

Pack sizes and marketing

Colourless glass, Type I.

Ampoules of 2 ml, in packages of 10 ampoules.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 30414/0003

21/02/2008 / 20/01/2011

Drugs

Drug Countries
NALPAIN Estonia, France, Poland

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