OXYCODONE HYDROCHLORIDE 50 mg/ml Solution for injection or infusion (2023)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

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

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 ...

Pharmaceutical form

Solution for injection or infusion. Clear colourless solution, practically free from visible particles.

Therapeutic indications

Oxycodone is indicated in adults for the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid.

Posology and method of administration

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with oxycodone in order to minimise the risk of addiction and drug withdrawal ...

Contraindications

Hypersensitivity to oxycodone or to any of the excipients listed in section 6.1. Oxycodone must not be used in any situation where opioids are contraindicated: severe respiratory depression with hypoxia; ...

Special warnings and precautions for use

Caution must be exercised when administering oxycodone to the debilitated elderly, patients with severely impaired pulmonary function, patients with impaired hepatic or renal function, patients with myxedema, ...

Interaction with other medicinal products and other forms of interaction

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant ...

Fertility, pregnancy and lactation

Use of this product should be avoided to the extent possible in patients who are pregnant or lactating. Pregnancy There are limited data from the use of oxycodone in pregnant women. Infants born to mothers ...

Effects on ability to drive and use machines

Oxycodone may impair the ability to drive and use machines. Oxycodone may modify patients' reactions to a varying extent depending on the dosage and individual susceptibility. Therefore, patients should ...

Undesirable effects

Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see section 4.4). Constipation may be prevented with an appropriate laxative. If nausea or vomiting are troublesome, ...

Overdose

Symptoms Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. Acute overdose ...

Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids ATC code: N02AA05 Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors ...

Pharmacokinetic properties

Pharmacokinetic studies in healthy subjects demonstrated an equivalent availability of oxycodone from Oxycodone Hydrochloride 50 mg/ml solution for injection or infusion when administered by the intravenous ...

Preclinical safety data

Reproductive and Development Toxicology Oxycodone had no effect on fertility or early embryonic development in male and female rats at doses as high as 8 mg/kg/d. Also, oxycodone did not induce any deformities ...

List of excipients

Citric acid monohydrate Sodium citrate dihydrate Sodium chloride Hydrochloric acid Sodium hydroxide Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. Cyclizine at concentrations of 3 mg/ml or less, when mixed with Oxycodone Hydrochloride 50 ...

Shelf life

Unopened ampoules: 3 years. Opened ampoules: The product should be used immediately after opening the ampoule. Prepared infusion solutions: Chemical and physical in-use stability has ...

Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Keep the ampoule in the outer carton in order to protect from light. For storage conditions after first opening or dilution ...

Nature and contents of container

Colourless glass ampoules with a nominal volume of 1 ml. Pack size: 5, 10 ampoules. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Each ampoule is for single use in a single patient. This medicine should be given immediately after opening the ampoule and any unused portion should be discarded. The medicinal product should be examined ...

Marketing authorization holder

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

Marketing authorization number(s)

PL 01502/0127

Date of first authorization / renewal of the authorization

01/06/2018

Date of revision of the text

19/04/2023

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