OXYNORM Capsule, hard (2023)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
OxyNorm 5 mg.
2. Qualitative and quantitative composition
Each capsule contains 4.5 mg of oxycodone as 5 mg of oxycodone hydrochloride. <u>Excipient with known effect:</u> OxyNorm 5 mg capsule contains sunset yellow (E110). May cause allergic reactions. For excipients, ...
3. Pharmaceutical form
Capsule, hard. Each 5 mg capsule is a size 4, hard gelatin, orange/beige, opaque capsule printed with ONR and 5.
4.1. Therapeutic indications
OxyNorm capsules are 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
Route of administration Oral. In common with other strong opioids, the need for continued treatment should be assessed at regular intervals. Posology If an immediate release opioid formulation is used ...
4.3. Contraindications
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: respiratory depression, head injury, paralytic ...
4.4. Special warnings and precautions for use
As with all narcotics, a reduction in dosage may be advisable in hypothyroidism. Use with caution in opioid dependent patients and in patients with severely impaired respiratory function, sleep apnoea, ...
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
OxyNorm capsules are not recommended for use in pregnancy nor during labour. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression. Oxycodone ...
4.7. Effects on ability to drive and use machines
Oxycodone may modify patients reactions to a varying extent depending on the dosage individual susceptibility. Therefore, patients should not drive or operate machinery if affected. This medicine can impair ...
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
Signs of oxycodone toxicity and overdosage are pin-point pupils, respiratory depression and hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma, skeletal muscle flaccidity, ...
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 opiate receptors ...
5.2. Pharmacokinetic properties
Absorption From immediate release formulations peak concentrations are generally attained around 1 hour. Distribution Following absorption, oxycodone is distributed throughout the entire body. Approximately ...
5.3. 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 ...
6.1. List of excipients
Cellulose, microcrystalline Magnesium stearate Titanium dioxide (E171) Iron oxide (E172) Indigo carmine (E132) Sunset yellow (E110) Sodium laurylsulphate Gelatin The capsules are printed with ink containing ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Four years.
6.4. Special precautions for storage
Do not store above 30°C.
6.5. Nature and contents of container
PVdC coated PVC blister packs with aluminium backing foil. Polypropylene container with polyethylene lid. <u>Pack sizes:</u> 56 capsules.
6.6. Special precautions for disposal and other handling
None stated.
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)
20304
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 27/03/2008 Renewal of the authorisation: 21/08/2018
10. Date of revision of the text
10/2023
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
