OXYNORM 10 mg/ml Solution for injection or infusion Ref.[27710] Active ingredients: Oxycodone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: Mundipharma Pharmaceuticals Ltd, 13, Othellos str., Dhali Industrial Zone, Nicosia, Cyprus Tel.: +357 22815656 Fax: +357 22487833 Email: info@mundipharma.com.cy

Product name and form

OxyNorm 10 mg/ml solution for injection or infusion.

Pharmaceutical Form

Solution for injection or infusion.

Clear, colourless solution, practically free from particulates.

Qualitative and quantitative composition

Oxycodone hydrochloride 10 mg/ml (equivalent to 9 mg/ml oxycodone).

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Oxycodone

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

List of Excipients

Citric acid monohydrate
Sodium citrate
Sodium chloride
Hydrochloric acid, dilute
Sodium hydroxide
Water for injections

Pack sizes and marketing

Clear neutral glass ampoules: 1 ml and 2 ml.

Pack size: 5 ampoules.

Marketing authorization holder

Mundipharma Pharmaceuticals Ltd, 13, Othellos str., Dhali Industrial Zone, Nicosia, Cyprus
Tel.: +357 22815656
Fax: +357 22487833
Email: info@mundipharma.com.cy

Marketing authorization dates and numbers

20303

Date of first authorization: 31/3/08
Date of latest renewal: 2/10/2019

Drugs

Drug Countries
OXYNORM Austria, Australia, Brazil, Cyprus, Spain, Finland, France, Hong Kong, Ireland, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa

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