OXYNORM 10 mg/ml Solution for injection or infusion (2023)
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Περιεχόμενα
1. Name of the medicinal product
OxyNorm 10 mg/ml solution for injection or infusion.
2. 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.
3. Pharmaceutical form
Solution for injection or infusion. Clear, colourless solution, practically free from particulates.
4.1. Therapeutic indications
OxyNorm injection is indicated in adults and adolescents (from 12 years and older) for the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe ...
4.2. 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. The correct dosage per individual patient is the lowest ...
4.3. Contraindications
OxyNorm injection is contraindicated in patients with known hypersensitivity to oxycodone or any of the excipients (see section 6.1). Oxycodone must not be used in any situation where opioids are contraindicated: ...
4.4. Special warnings and precautions for use
As with all opioids, a reduction in dosage may be advisable in hypothyroidism. Use with caution in debilitated elderly or patients with severely impaired respiratory function, sleep apnoea, tolerance, ...
4.5. 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 ...
4.6. Pregnancy and lactation
The effect of oxycodone in human reproduction has not been adequately studied. No studies on fertility or the post-natal effects of intrauterine exposure have been carried out. However, studies in rats ...
4.7. Effects on 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 not drive or operate machinery, if affected. This medicine ...
4.8. Undesirable effects
Adverse drug reactions are typical of full opioid agonists. Tolerance and dependence may occur (see Tolerance and Dependence, below). Constipation may be prevented with an appropriate laxative. If nausea ...
4.9. Overdose
Symptoms of overdosage Signs of oxycodone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or coma, skeletal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Natural opium alkaloids <b>ATC code:</b> N02AA05 Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors ...
5.2. Pharmacokinetic properties
Pharmacokinetic studies in healthy subjects demonstrated an equivalent availability of oxycodone from OxyNorm injection when administered by the intravenous and subcutaneous routes, as a single bolus dose ...
5.3. Preclinical safety data
Reproductive and Developmental 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 ...
6.1. List of excipients
Citric acid monohydrate Sodium citrate Sodium chloride Hydrochloric acid, dilute Sodium hydroxide Water for injections
6.2. 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 OxyNorm injection, either undiluted ...
6.3. Shelf life
5 years unopened. After opening use immediately. For further information see Section 6.6.
6.4. Special precautions for storage
No special precautions for storage prior to opening. For further information on use after opening see Section 6.6.
6.5. Nature and contents of container
<u>Clear neutral glass ampoules:</u> 1 ml and 2 ml. <u>Pack size:</u> 5 ampoules.
6.6. Special precautions for disposal
For intravenous use OxyNorm injection concentrate for solution for infusion should be diluted to a concentration of 1 mg/ml oxycodone hydrochloride. The following solutions for infusion/injection can be ...
7. 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
8. Marketing authorization number(s)
20303
9. Date of first authorization / renewal of the authorization
Date of first authorization: 31/3/08 Date of latest renewal: 2/10/2019
10. Date of revision of the text
10/2023
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