Oxycodone hydrochloride 10mg/ml solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYCODONE HYDROCHLORIDE

Available from:

hameln pharma gmbh

ATC code:

N02AA05

INN (International Name):

OXYCODONE HYDROCHLORIDE

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

oxycodone

Authorization status:

Not marketed

Authorization date:

2018-12-21

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
OXYCODONE HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION OR INFUSION
oxycodone hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
•
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.
The name of your medicine is Oxycodone Hydrochloride 10 mg/ml solution
for injection or infusion,
which will be referred to as Oxycodone Injection throughout this
leaflet.
WHAT IS IN THIS LEAFLET
1.
What Oxycodone Injection is and what it is used for
2.
What you need to know before you use Oxycodone Injection
3.
How to use Oxycodone Injection
4.
Possible side effects
5.
How to store Oxycodone Injection
6.
Contents of the pack and other information
1.
WHAT OXYCODONE INJECTION IS AND WHAT IT IS USED FOR
This medicine 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".
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OXYCODONE INJECTION
DO NOT USE OXYCODONE INJECTION:
•
if you are allergic to oxycodone, or any of the other ingredients of
this medicine (listed in section
6);
•
if you 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;
•
if you have a condition where the small bowel does not work properly
(paralytic ileus) or you have
severe pain in your abdomen;
•
if you have a heart problem after long-term lung disease (cor
pulmonale);
•
if you have ongoing problems with constipation;
•
if you ar

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2024
CRN00F4HR
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxycodone hydrochloride 10mg/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml ampoule contains 10 mg oxycodone hydrochloride (equivalent
to 9 mg oxycodone).
Each 2 ml ampoule contains 20 mg oxycodone hydrochloride (equivalent
to 18 mg oxycodone).
Excipients with known effect:
This medicinal product contains less than 1 mmol sodium (23 mg) per 1
ml, that is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear colourless solution, practically free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oxycodone is indicated in adults 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
Posology
The dose should be adjusted according to the severity of pain, the
total condition of the patient and previous or concurrent
medication.
_Adults _
The following starting doses are recommended. A gradual increase in
dose may be required if analgesia is inadequate or if pain
severity increases.
Intravenous - 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.
Intravenous - Infusion
Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections.
A starting dose of 2 mg/hour is recommended.
Intravenous - Patient Controlled Analgesia (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.
Subcutaneous - Bolus
Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended,
repeated at 4-hourly intervals as re