HYDROMORPHONE JUNO hydromorphone hydrochloride 2 mg/1 mL injection solution ampoules

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydromorphone hydrochloride, Quantity: 2 mg

Available from:

Juno Pharmaceuticals Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Subcutaneous, Intramuscular

Units in package:

5 x 1 mL ampoules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

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 to pale yellow solution.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 32 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-05-06

Patient Information leaflet

HYDROMORPHONE JUNO/HYDROMORPHONE JUNO-HP/ HYDROMORPHONE JUNO-XHP
1
HYDROMORPHONE JUNO/HYDROMORPHONE JUNO-HP/
HYDROMORPHONE JUNO-XHP
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 USING HYDROMORPHONE JUNO/JUNO-HP/JUNO-XHP?
HYDROMORPHONE JUNO/JUNO-HP/JUNO-XHP contain the active ingredient
hydromorphone hydrochloride. Hydromorphone
is used 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 using HYDROMORPHONE? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE HYDROMORPHONE JUNO/JUNO-HP/JUNO-XHP?
Do not use if you have ever had an allergic reaction to hydromorphone
or any of the ingredients listed at the end of the CMI.
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 use
HYDROMORPHONE?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with hydromorphone 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 I USE HYDROMORPHONE JUNO/JUNO-HP/JUNO-XHP?
•
Your doctor will decide the appropriate dose for you.
•
A doctor or nurse will usually prepare and administer the injection or
infusion.
•
Follow all instructions given to you by your doctor and pharmacist.
More instructions can be found in Section 4. How do I use
HYDROMORPHONE?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING HYDROMORPHONE JUNO/JUNO-HP/JUNO-XHP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are
receiving hydromorphone.
�

Summary of Product characteristics

Australian Product Information
PI v: 3.0
Page 1
AUSTRALIAN PRODUCT INFORMATION
HYDROMORPHONE JUNO _(HYDROMORPHONE HYDROCHLORIDE) _INJECTION
HYDROMORPHONE JUNO-HP _(HYDROMORPHONE HYDROCHLORIDE) _INJECTION
HYDROMORPHONE JUNO-XHP _(HYDROMORPHONE HYDROCHLORIDE) _CONCENTRATED
INJECTION
_ _
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, hydromorphone
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 _
Hydromorphone 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 hydromorphone. 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 hydromorphone.
1 NAME OF THE MEDICINE
Hydromorphone hydrochloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydromorpho