Oxycodone Juno oxycodone hydrochloride 200 mg / 20 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 200 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Subcutaneous, Intravenous

Units in package:

4 ampoules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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: Clear and colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-08-31

Patient Information leaflet

OXYCODONE JUNO SOLUTION FOR INJECTION OR INFUSION
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 JUNO?
Oxycodone J
uno contains the active ingredient oxycodone hydrochloride. Oxycodone
Juno 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 J
uno? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN OXYCODONE JUNO?
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 JUNO WORKS AND MAY RESULT IN SIDE-EFFECTS.
PRIOR TO BEING TREATED WITH OXYCODONE JUNO, 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-J
uno? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Oxycodone J
uno and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? i
n the full CMI.
4.
HOW WILL I BE GIVEN OXYCODONE JUNO?
•
Your doctor will decide the appropriate dose for you.
•
Follow the instructions given to you by your doctor or pharmacist
exactly.
•
Oxycodone Juno 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 J
uno? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING OXYCODONE JUNO?
THINGS YOU
SHOULD DO
•
•
Remind any doctor, dentist or pharmacist

Summary of Product characteristics

Juno Pharmaceuticals Pty Ltd
Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
OXYCODONE JUNO _(OXYCODONE HYDROCHLORIDE) _
_ _
WARNINGS
LIMITATIONS OF USE
Because of the risks associated with the use of opioids, Oxycodone
Juno 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 Juno 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
Juno. 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
receiving Oxycodone Juno.
1 NAME OF THE MEDICINE
Oxycodone hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone Juno 10 mg / 1 mL solution for injection ampoule contains 10
mg of oxycodone
hydrochloride.
Oxycodone Juno 20 mg / 2 mL solution for injection ampoule cont