OXYCODONE-HAMELN oxycodone hydrochloride 10 mg/1 mL injection solution ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 10 mg

Available from:

Hameln Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium citrate dihydrate; sodium hydroxide; sodium chloride; hydrochloric acid; water for injections; citric acid monohydrate

Administration route:

Subcutaneous, Intravenous Infusion, Intravenous Bolus

Units in package:

5 ampoules, 10 ampoules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Oxycodone-hameln solution for injection or infusion is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: A clear colourless solution for injection free of visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-10-07

Patient Information leaflet

OXYCODONE-HAMELN v1.0 020721
1
OXYOCODONE-HAMELN INJECTION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN OXYCODONE-HAMELN?
Oxycodone-hameln contains the active ingredient oxycodone
hydrochloride. Oxycodone-hameln is used for the short-term
relief of severe pain for which other treatment options have failed or
otherwise unsuitable to provide sufficient management
of pain.
For more information, see Section 1. Why am I being given
Oxycodone-hameln
? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN OXYCODONE-HAMELN?
Do not use if you have ever had an allergic reaction to oxycodone or
any of the ingredients listed at the end of the CMI.
A NUMBER OF MEDICAL CONDITIONS AND OTHER DRUGS CAN AFFECT THE WAY
OXYCODONE-HAMELN WORKS AND MAY RESULT IN SIDE-
EFFECTS. PRIOR TO BEING TREATED WITH OXYCODONE-HAMELN, TALK TO YOUR
DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Oxycodone-hameln
? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Oxycodone-hameln and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO WILL I BE GIVEN OXYCODONE-HAMELN?
•
Your doctor will decide the appropriate dose for you.
•
Follow the instructions given to you by your doctor or pharmacist
exactly.
•
Oxycodone-hameln must only be administered by injection, and will
normally be given to you by a doctor or nurse.
More instructions can be found in Section 4. How will I be given
Oxycodone
-hameln? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OXYCODONE-HAMELN?
THINGS YOU
SHOULD DO
•
Remind an

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – OXYCODONE-HAMELN (OXYCODONE
HYDROCHLORIDE) SOLUTION FOR INJECTION OR INFUSION
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids,
Oxycodone-hameln solution for injection or
infusion should only be used in patients for whom other treatment
options, including non- opioid
analgesics, are ineffective, not tolerated or otherwise inadequate to
provide appropriate management
of pain (see section 4.4 Special Warnings and Precautions for Use).
_HAZARDOUS AND HARMFUL USE _
Oxycodone-hameln solution for injection or infusion poses risks of
hazardous and harmful use which can
lead to overdose and death. Assess the patient’s risk of hazardous
and harmful use before prescribing
and monitor the patient regularly during treatment (see section 4.4.
Special Warnings and Precautions
for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of Oxycodone-hameln
solution
for
injection or infusion.
Be
aware
of
situations which
increase the
risk
of
respiratory
depression, modify dosing in patients at risk and monitor patients
closely, especially on initiation or
following a dose increase (see section 4.4 Special Warnings and
Precautions for Use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS, INCLUDING _
_ALCOHOL _
Concomitant
use
of
opioids
with
benzodiazepines,
gabapentinoids,
antihistamines,
tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death. Limit dosages and
durations to the minimum required; and monitor patients for signs and
symptoms of respiratory
depression and sedation. Caution patients not to drink alcohol while
taking Oxycodone-hameln solution
for injection or infusion.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone-hameln 10 mg in 1 mL; 20 mg i