MEDSURGE HYDROMORPHONE HP 10 mg/1 mL hydromorphone hydrochloride 10 mg/1 mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

hydromorphone hydrochloride, Quantity: 10 mg

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

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

Administration route:

Intravenous, Intramuscular, Subcutaneous

Units in package:

10 x 1 mL, 5 x 1 mL

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: Clear colourless to yellowish solution; Container Type: Ampoule; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2019-11-08

Patient Information leaflet

CMI EDITION 2.0 DECEMBER 2020
1
MEDSURGE HYDROMORPHONE INJECTION/
HYDROMORPHONE HP INJECTION/
HYDROMORPONE XHP CONCENTRATED INJECTION
_Hydromorphone hydrochloride _
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
HYDROMORPHONE/HYDROMORPHONE HP/HYDROMORPHONE XHP injections should
only be used when your
doctor decides that other treatment options are not able to
effectively manage your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
HYDROMORPHONE/HYDROMORPHONE HP/HYDROMORPHONE XHP injections poses
risks of abuse, misuse and
addiction which can lead to overdose and death. Your doctor will
monitor you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
HYDROMORPHONE/HYDROMORPHONE HP/HYDROMORPHONE XHP injections can cause
life-threatening or fatal
breathing problems (slow, shallow, unusual or no breathing) even when
used as recommended. These problems can occur at
any time during use, but the risk is higher when first starting
HYDROMORPHONE/HYDROMORPHONE
HP/HYDROMORPHONE XHP injections and after a dose increase, if you are
older, or have an existing problem with your
lungs. Your doctor will monitor you and change the dose as
appropriate.
USE OF OTHER MEDICINES WHILE USING HYDROMORPHONE/HYDROMORPHONE
HP/HYDROMORPHONE XHP
Your doctor will minimise the dose and duration of use; and monitor
you for signs and symptoms of breathing difficulties and
sedation. You must not drink alcohol while using
HYDROMORPHONE/HYDROMORPHONE HP/HYDROMORPHONE
XHP injections.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Medsurge
Hydromorphone, Medsurge
Hydromorphone HP (HP = High
Potency) and Medsurge
Hydromorphone XHP (XHP = Extra
High Potency) injections.
It does not contain all the available
information. It does not take the place
of talking to your doctor or
pharmacist.
All medicines have benefits and risks.
Your doctor has weighed the benefits
of you using this medicine against the
risks it may have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, TALK TO YOUR DOCTOR

Summary of Product characteristics

HYDROMORPHONE HYDROCHLORIDE
_ _
PRODUCT INFORMATION
Edition 2.0 – December 2020
Page
1
of
19
AUSTRALIAN PRODUCT INFORMATION
MEDSURGE HYDROMORPHONE AND MEDSURGE HYDROMORPHONE HP
(HYDROMORPHONE HYDROCHLORIDE) SOLUTION FOR INJECTION
MEDSURGE HYDROMORPHONE XHP (HYDROMORPHONE
HYDROCHLORIDE) CONCENTRATED SOLUTION FOR INJECTION
WARNINGS
_ _
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids,
HYDROMORPHONE/HYDROMORPHONE
HP/HYDROMORPHONE XHP injections 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/HYDROMORPHONE
HP/HYDROMORPHONE
XHP
injections
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/HYDROMORPHONE
HP/HYDROMORPHONE
XHP
injections.
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
sedat