Country: Cyprus
Bahasa: Greek
Sumber: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
OXYCODONE HYDROCHLORIDE
MUNDIPHARMA PHARMACEUTICALS LTD (0000003104) 13 OTHELLOS STR, NICOSIA, 1685, 23661
N02AA05
OXYCODONE
5MG
CAPSULE,HARD
OXYCODONE HYDROCHLORIDE (0000124903) 5MG BASE
ORAL USE
Εθνική Διαδικασία
OXYCODONE
Νομικό καθεστώς: Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία; PACK WITH 56 CAPS IN BLISTER(S) (260012401) 56 CAPSULE - Εγκεκριμένο - Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT OxyNorm 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITIOIN Each capsule contains 4.5 mg oxycodone as 5 mg of oxycodone hydrochloride. For excipients, see section 6.1 3. PHARMACEUTICAL FORM Capsule, hard. OxyNorm capsules 5 mg are orange/beige, printed ONR 5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. 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. Elderly and adults over 18 years: OXYNORM capsules should be taken at 4-6 hourly intervals. The dosage is dependent on the severity of the pain, and the patients previous history of analgesic requirements. Increasing severity of pain will require an increased dosage of OxyNorm capsules. The correct dosage for any individual patient is that which controls the pain and is well tolerated throughout the dosing period. Patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg. However, a few patients may require higher doses. SPCONC01v2.02a Patients receiving oral morphine before oxycodone therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that is a quide to the dose of OXYNORM capsules required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Controlled pharmacokinetic studies in elderly pat Baca dokumen lengkap