Oxycodone hydrochloride 50mg/ml solution for injection or infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

OXYCODONE HYDROCHLORIDE

Dostopno od:

Wockhardt UK Limited

Koda artikla:

N02AA; N02AA05

INN (mednarodno ime):

OXYCODONE HYDROCHLORIDE

Odmerek:

50 milligram(s)/millilitre

Farmacevtska oblika:

Solution for injection/infusion

Tip zastaranja:

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

Terapevtsko območje:

Natural opium alkaloids; oxycodone

Status dovoljenje:

Not marketed

Datum dovoljenje:

2013-08-09

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxycodone Hydrochloride 50 mg/ml Solution for Injection or Infusion
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, pharmacist or
nurse.

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.
THE NAME OF YOUR MEDICINE IS OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION
FOR INJECTION OR INFUSION.
IN THE REST OF THIS LEAFLET IT IS CALLED OXYCODONE INJECTION.
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 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’.
The other ingredients are listed in section 6 of this leaflet.
2. What you need to know before you use Oxycodone Injection
DO NOT USE OXYCODONE INJECTION IF YOU:
• are allergic (hypersensitive) to oxycodone, or any of the other
ingredients of the injection (listed in section
6);
• 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 condition where the small bowel does not work properly
(paral

Lastnosti izdelka

Health Products Regulatory Authority
10 June 2019
CRN008ZLY
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oxycodone hydrochloride 50mg/ml solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains oxycodone hydrochloride 50 mg (equivalent to 45 mg of
oxycodone base).
This medicinal product contains less than 1 mmol sodium (23 mg) per
dose.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion (injection or infusion).
A clear, colourless solution practically free of particles.
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:_
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 in 0.9% saline, 5% dextrose or water for
injections. Administer a bolus dose of 1 to 10 mg slowly over one to
two minutes in opioid naive patients.
Doses should not be administered more frequently than every four
hours.
i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is recommended for
opioid naive patients.
i.v. (PCA): Dilute 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 five minutes for opioid naive patients.
s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 5 mg is recommended, repeated at
four-hourly intervals as required for opioid naive patients.
Hea