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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

OXYCODONE HYDROCHLORIDE Solution for injection or infusion (2019)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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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

Posology The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. Adults The following starting doses are recommended. A ...

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

The major risk of opioid excess is respiratory depression. Caution must be exercised when administering oxycodone to the debilitated elderly; patients with severely impaired pulmonary function, patients ...

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 Acute overdose with oxycodone can be manifested by miosis, respiratory depression, hypotension and hallucinations. Nausea and vomiting are common in less severe cases. Non-cardiac pulmonary oedema ...

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 in the ...

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 as a 5mg dose ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Teratogenicity Oxycodone had no effect on fertility ...

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

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 been demonstrated ...

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 plus gmbh, Langes Feld 13, 31789, Hameln, Germany

Marketing authorization number(s)

PL 25215/0036

Date of first authorization / renewal of the authorization

01/06/2018

Date of revision of the text

07/11/2019

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