OXYCODONE HYDROCHLORIDE 50 mg/ml Solution for injection or infusion Ref.[8078] Active ingredients: Oxycodone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom

Product name and form

Oxycodone Hydrochloride 50 mg/ml solution for injection or infusion.

Pharmaceutical Form

Solution for injection or infusion.

Clear colourless solution, practically free from visible particles.

Qualitative and quantitative composition

Each 1 ml ampoule contains 50 mg oxycodone hydrochloride (equivalent to 45 mg oxycodone).

Excipients with known effect: This medicinal product contains less than 1 mmol sodium (23 mg) per 1 ml, that is to say essentially ‘sodium-free’.

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 dihydrate
Sodium chloride
Hydrochloric acid
Sodium hydroxide
Water for injections

Pack sizes and marketing

Colourless glass ampoules with a nominal volume of 1 ml.

Pack size: 5, 10 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, United Kingdom

Marketing authorization dates and numbers

PL 01502/0127

01/06/2018

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