OXYNORM CONCENTRATE 10MG/ML ORAL SOLUTION

Nazione: Cipro

Lingua: greco

Fonte: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Principio attivo:

OXYCODONE HYDROCHLORIDE

Commercializzato da:

MUNDIPHARMA PHARMACEUTICALS LTD (0000003104) 13 OTHELLOS STR, NICOSIA, 1685, 23661

Codice ATC:

N02AA05

INN (Nome Internazionale):

OXYCODONE

Dosaggio:

10MG/ML

Forma farmaceutica:

ORAL SOLUTION

Composizione:

OXYCODONE HYDROCHLORIDE (0000124903) 10MG

Via di somministrazione:

ORAL USE

Tipo di ricetta:

Εθνική Διαδικασία

Area terapeutica:

OXYCODONE

Dettagli prodotto:

Νομικό καθεστώς: Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία; 1 BOTTLE X 120ML (280022901) 120 MILLILITRE - Εγκεκριμένο - Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
_OXYNORM_ concentrate 10 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml _OXYNORM_ concentrate contains oxycodone base 9 mg as
oxycodone
hydrochloride 10 mg.
For excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
_OXYNORM_ concentrate is a clear orange solution.
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
_Post-operative pain:_
In common with other strong opioids, the need for continued treatment
should be
assessed at regural intervals.
_Elderly and adults over 18 years:_
_OXYNORM_ concentrate should be taken at 4-6 hourly intervals. The
dosage is
dependent on the severity of the pain, and the patient’s previous
history of analgesic
requirements.
Increasing severity of pain will require an increased dosage of
_OXYNORM_ concentrate.
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.
SPCOXC01v1.02a
The usual starting dose for opioid naïve 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.
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 this is a guide to the dose
of _OXYNORM_
concentrate required. Inter-patient variability requires that each
patient is carefully
titrated to the ap