OxyNorm 20mg/2ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Oxycodone hydrochloride

Available from:

Napp Pharmaceuticals Ltd

ATC code:

N02AA05

INN (International Name):

Oxycodone hydrochloride

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous; Intravenous

Class:

Schedule 2 (CD)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012854047365

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
_OXYNORM_
_®_
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.

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.
IN THIS LEAFLET:
1.
What _OXYNORM _injection is and what it is used for
2.
What you need to know before you use _OXYNORM _injection
3.
How to use_ OXYNORM _injection
4.
Possible side effects
5.
How to store _OXYNORM _injection
6.
Contents of the pack and other information
1.
WHAT _OXYNORM _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’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE_ OXYNORM _INJECTION
DO NOT USE_ OXYNORM _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
(paralytic ileus) or you have severe pain in
your abdomen;

have a heart problem after long-term lung disease (cor pulmonale);

have moderate to severe liver problems. If you have other long-term
liver problems you should

Summary of Product characteristics

OBJECT 1
OXYNORM 10 MG/ML SOLUTION FOR INJECTION OR
INFUSION
Summary of Product Characteristics Updated 30-May-2018 | Napp
Pharmaceuticals Limited
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 9 mg/ml oxycodone)
For the full list of 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
_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 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 1 mg/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 starting 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 oxycod