OXYCODONE HYDROCHLORIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: OXYCODONE HYDROCHLORIDE

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This leaflet provides technical information for the healthcare professional about Oxynorm 10 mg/ml solution
for injection or infusion.
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.

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 1-2 minutes in opioid naïve patients. Doses should not be administered more frequently than
every 4 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 naïve 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 5 minutes for opioid naïve patients.

CUSTOMER: WAYMADE
PRODUCT: Oxynorm 10mg solution Professional leaf

Code : 06464/2871

s.c. (Bolus): A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required for opioid
naïve patients.
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 oxynorm may require much higher doses (see below).
Transferring patients between oral and parenteral Oxycodone:
The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral
oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires
that each patient is carefully titrated to the appropriate dose.
Elderly:
Elderly patients should be treated with caution. The lowest dose should be administered with careful titration
to pain control.
Patients with renal and hepatic impairment:
Patients with mild to moderate renal impairment and/or mild hepatic impairment should be treated with
caution. The lowest dose should be given with careful titration to pain control.
Children under 18 years:
There are no data on the use of Oxynorm injection in patients under 18 years of age.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO CRESTOR 6464/2069 2070

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.

Leaflet Flat Size = 148 x 210

REF: JULY 2009
ARTWORKER: DT

DATE OF PROOF: 03/04/14

QA APPROVED
DATE:

OXYNORM® 10 mg/ml solution for injection or infusion
Oxycodone hydrochloride
Information for Health Professionals

PROOF HISTORY:v.1 - waymade - 03/04/14

000-0000

From a microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2 to 8°C, unless reconstitution/dilution (etc) has taken place in controlled and
validated aseptic conditions.
Oxynorm injection, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for
injections, is physically and chemically stable when in contact with representative brands of polypropylene
or polycarbonate syringes, polyethylene or PVC tubing and PVC or EVA infusion bags, over a 24 hour
period at room temperature.
The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and
contained in the various assemblies, does not need to be protected from light. Inappropriate handling of the
undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the
sterility of the product.

CUSTOMER: WAYMADE
PRODUCT: Oxynorm 10mg solution Professional leaf

Code : 06464/2871

POM

CD

PL 06464/2871

This product is manufactured by Hamol Limited, 1 Thane Road, Nottingham, NG90 2DB, United Kingdom
and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon Essex SS14 3FR
Leaflet revision and issue date (Ref) 03.04.2014
Oxynorm is a registered trademark of Mundipharma AG.

PROOF HISTORY:v.1 - waymade - 03/04/14

Instructions for use/handling
Each ampoule is for single use in a single patient. The injection should be given immediately after opening
the ampoule and any unused portion should be discarded. Chemical and physical in-use stability has been
demonstrated for 24 hours at room temperature.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO CRESTOR 6464/2069 2070

Cessation of Therapy:
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually
to prevent symptoms of withdrawal.

Leaflet Flat Size = 148 x 210

REF: JULY 2009
ARTWORKER: DT

DATE OF PROOF: 03/04/14

QA APPROVED
DATE:

Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only
treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic
osteoarthritic pain and intervertebral disc disease.
The need for continued treatment in non-malignant pain should be assessed at regular intervals.

This leaflet provides technical information for the healthcare professional about Oxycodone Hydrochloride
10 mg/ml solution for injection or infusion, referred to as Oxycodone injection in this leaflet.
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.

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 1-2 minutes in opioid naïve patients. Doses should not be administered more frequently than
every 4 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 naïve 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 5 minutes for opioid naïve patients.

CUSTOMER: WAYMADE
PRODUCT: Oxycodone 10mg solution Professional leaf

Code : 06464/2871

s.c. (Bolus): A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required for opioid
naïve patients.
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 should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral
oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires
that each patient is carefully titrated to the appropriate dose.
Elderly:
Elderly patients should be treated with caution. The lowest dose should be administered with careful titration
to pain control.
Patients with renal and hepatic impairment:
Patients with mild to moderate renal impairment and/or mild hepatic impairment should be treated with
caution. The lowest dose should be given with careful titration to pain control.
Children under 18 years:
There are no data on the use of Oxycodone injection in patients under 18 years of age.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO CRESTOR 6464/2069 2070

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.

Leaflet Flat Size = 148 x 210

REF: JULY 2009
ARTWORKER: DT

DATE OF PROOF: 03/04/14

QA APPROVED
DATE:

OXYCODONE HYDROCHLORIDE 10 mg/ml solution
for injection or infusion
Information for Health Professionals

PROOF HISTORY:v.1 - waymade - 03/04/14

000-0000

From a microbiological point of view, the product should be used immediately. If not used immediately,
in-use storage times and conditions prior to use are the responsibility of the user and would normally not be
longer than 24 hours at 2 to 8°C, unless reconstitution/dilution (etc) has taken place in controlled and
validated aseptic conditions.
Oxycodone injection, undiluted or diluted to 1 mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for
injections, is physically and chemically stable when in contact with representative brands of polypropylene
or polycarbonate syringes, polyethylene or PVC tubing and PVC or EVA infusion bags, over a 24 hour
period at room temperature.
The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and
contained in the various assemblies, does not need to be protected from light. Inappropriate handling of the
undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the
sterility of the product.

CUSTOMER: WAYMADE
PRODUCT: Oxycodone 10mg solution Professional leaf

Code : 06464/2871

POM

CD

PL 06464/2871

This product is manufactured by Hamol Limited, 1 Thane Road, Nottingham, NG90 2DB, United Kingdom
and is procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon Essex SS14 3FR
Leaflet revision and issue date (Ref) 03.04.2014

PROOF HISTORY:v.1 - waymade - 03/04/14

Instructions for use/handling
Each ampoule is for single use in a single patient. The injection should be given immediately after opening
the ampoule and any unused portion should be discarded. Chemical and physical in-use stability has been
demonstrated for 24 hours at room temperature.

ARIAL REGULAR FONT SIZE 8
ARIAL REGULAR BOLD FONT SIZE 8
BRIDGED TO CRESTOR 6464/2069 2070

Cessation of Therapy:
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually
to prevent symptoms of withdrawal.

Leaflet Flat Size = 148 x 210

REF: JULY 2009
ARTWORKER: DT

DATE OF PROOF: 03/04/14

QA APPROVED
DATE:

Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain, nor are they recommended as the only
treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic
osteoarthritic pain and intervertebral disc disease.
The need for continued treatment in non-malignant pain should be assessed at regular intervals.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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