Oxycodone hydrochloride 50 mg/ml solution for injection/infusion

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

OXYCODONE HYDROCHLORIDE

Tilgængelig fra:

AS Kalceks

ATC-kode:

N02AA; N02AA05

INN (International Name):

OXYCODONE HYDROCHLORIDE

Dosering:

50 milligram(s)/millilitre

Lægemiddelform:

Solution for injection/infusion

Terapeutisk område:

Natural opium alkaloids; oxycodone

Autorisation dato:

2019-04-26

Indlægsseddel

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODONE HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION/INFUSION
OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION/INFUSION
oxycodone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Oxycodone is and what it is used for
2.
What you need to know before you use Oxycodone
3.
How to use Oxycodone
4.
Possible side effects
5.
How to store Oxycodone
6.
Contents of the pack and other information
1.
WHAT OXYCODONE
IS AND WHAT IT IS USED FOR
This injection has been prescribed for you by your doctor to relieve
moderate to severe pain. It
contains the active ingredient oxycodone which belongs to a group of
medicines called strong
analgesics or ‘painkillers’.
Oxycodone is indicated in adults only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXYCODONE_ _
DO NOT USE OXYCODONE:
-
if you are allergic to oxycodone or any of the other ingredients of
this medicine (listed in
section 6);
-
if you have known sensitivity to morphine or other opioids;
-
have breathing problems, such as severe chronic obstructive lung
disease, severe bronchial
asthma or severe respiratory depression. Your doctor will have told
you if you have any of these
conditions. Symptoms may include breathlessness, coughing or breathing
more slowly or weakly
than expected;
-
have a heart problem after long-term lung disease (cor pulmonale);
-
have a condition where the small bowel does not work properly
(paralytic ileus) or you have
severe pain in your abdomen;
-
have ongoing problems

Produktets egenskaber

Health Products Regulatory Authority
26 March 2024
CRN00F548
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxycodone hydrochloride 50 mg/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 50 mg of oxycodone hydrochloride
(equivalent to 45 mg of oxycodone).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion).
Clear, colourless solution, free from visible particles.
pH of solution is 4.5‑5.5.
Osmolality is approximately 285 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of moderate to severe pain in patients with cancer
and postoperative pain.
For the treatment of severe pain requiring the use of a strong opioid.
Oxycodone is indicated in adults only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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:_
The following starting doses are recommended. A gradual increase in
dose may be required if analgesia is inadequate or if pain
severity increases.
IV (Bolus): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%)
solution for injection, 50 mg/ml (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.
IV (Infusion): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%)
solution for injection, 50 mg/ml (5%) dextrose or water for
injections.
A starting dose of 2 mg/hour is recommended.
IV (PCA): Dilute to 1 mg/ml in sodium chloride 9 mg/ml (0.9%) solution
for injection, 50 mg/ml (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.
SC (Bolus): Use as 10 mg/ml concentration. Oxycodone 50 mg/ml dilute
in sodium chloride 9 mg/ml (0.9%) solution for
injection, 50 mg/ml (5%) dextrose or