OXYNORM LIQUID 5MG/5ML 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:

5MG/5ML

Forma farmaceutica:

ORAL SOLUTION

Composizione:

OXYCODONE HYDROCHLORIDE (0000124903) 5MG

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 250ML (280022801) 250 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_ liquid 5mg/5ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml _OXYNORM_ liquid contains oxycodone base 4.5 mg as oxycodone
hydrochloride 5 mg.
For excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
_OXYNORM_ liquid is a clear colourless/straw-coloured 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_ liquid 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_ liquid. 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 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
SPCOXL01v1.02a
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_
liquid required. Inter-patient variability requires that each patient
is carefully titrated
to the appropriate