OXYNORM 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Երկիր: Կիպրոս

Լեզու: հունարեն

Աղբյուրը: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Ակտիվ բաղադրիչ:

OXYCODONE HYDROCHLORIDE

Հասանելի է:

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

ATC կոդը:

N02AA05

INN (Միջազգային անվանումը):

OXYCODONE

Դոզան:

10MG/ML

Դեղագործական ձեւ:

SOLUTION FOR INJECTION OR INFUSION

Կազմը:

OXYCODONE HYDROCHLORIDE (0000124903) 10MG

Կառավարման երթուղին:

INTRAVENOUS USE; ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ

Ռեկվիզորի տեսակը:

Εθνική Διαδικασία

Թերապեւտիկ տարածք:

OXYCODONE

Ապրանքի ամփոփագիր:

Νομικό καθεστώς: Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία; PACK WITH 5 AMPS X 1ML (270009601) 5 AMPOULE - Εγκεκριμένο - Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία; PACK WITH 5 AMPS X 2ML (270009602) 5 AMPOULE - Εγκεκριμένο - Με Ιατρική Συνταγή σύμφωνα με την Περί Ναρκωτικών Φαρμάκων και Ψυχοτρόπων Ουσιών Νομοθεσία

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
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 9mg/ml oxycodone)
For excipients, see Section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection or infusion.
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:_
Subcutaneous injection or infusion.
Intravenous injection or infusion.
_Posology:_
The dose should be adjusted according to the severity of pain, the
total condition of
the patient and previous or concurrent medication.
_Adults over 18 years:_
SPCOXI01v1.02a
The following starting doses are recommended. A gradual increase in
dose may be
required if analgesia is inadequate or if pain severity increases.
i.v. (Bolus): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water
for injections.
Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes.
Doses should not be administered more frequently than every 4 hours.
i.v. (Infusion): Dilute to 1mg/ml in 0.9% saline, 5% dextrose or water
for injections.
A starting dose of 2 mg/hour is recommended.
i.v. (PCA): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for
injections.
Bolus doses of 0.03 mg/kg should be administered with a minimum
lock–out time of
5 minutes.
s.c. (Bolus): Use as 10 mg/ml concentration. A strong dose of 5 mg is
recommended,
repeated at 4-hourly intervals as required.
s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections if required.
A starting dose of 7.5 mg/day is recommended in opioid naïve
patients, titrating
gradually according to symptom control. Cancer patients transferring
from oral
oxycodone may require much higher doses (see below).
_Transferring patients between oral and parenteral oxycodone:_
The dose sho