MORPHINE JUNO morphine hydrochloride trihydrate 20 mg/1 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

morphine hydrochloride trihydrate, Quantity: 20 mg/mL

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

morphine hydrochloride trihydrate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; dilute hydrochloric acid

Administration route:

Intramuscular, Intravenous Infusion, Subcutaneous

Units in package:

5 and 10

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

- 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. - Symptomatic relief of severe and intractable pains in terminal cancer patients. - Use as a pre-operative medication and as an analgesic adjunct in general anaesthesia.

Product summary:

Visual Identification: Clear colourless to pale yellow solution in a yellow ampoule; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-05-06

Patient Information leaflet

Page 1
MORPHINE JUNO
Morphine hydrochloride trihydrate injection
_(MOR-feen)_
_ _
_ _
CONSUMER MEDICINE INFORMATION
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name_
_Consumer Address _
_Pharmacist Address_
_ _
_ _
WARNING
LIMITATIONS OF USE
Morphine Injection 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
Morphine Injection 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
Morphine Injection 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 morphine hydrochloride
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 MORPHINE
Using morphine hydrochloride with other medicines that can make you
feel drowsy such as
sleeping tablets (e.g. benzodiazepines), other pain relievers,
antihistamines, antidepressants,
antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin),
cannabis and alcohol may result
in severe drowsiness, decreased awareness, breathing problems, coma
and death. 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
morphine.
Page 2
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Morphine Juno morphine
hydrochloride trihydrate injection
(Morphine). It does not contain all
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has
weighed the risks of you being
given Morphine Juno against the
benefits they exp

Summary of Product characteristics

Australian Product Information
Page | 1
AUSTRALIAN PRODUCT INFORMATION
MORPHINE JUNO (MORPHINE HYDROCHLORIDE TRIHYDRATE)_ _
_ _
1 NAME OF THE MEDICINE
Morphine hydrochloride trihydrate.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Morphine Juno is a sterile solution containing morphine hydrochloride
10 milligrams/mL and
20 milligrams/mL in water for injections. The solution does not
contain any antioxidant or
preservative. The pH of the solution ranges between 3.0 and 5.0, 0.1N
hydrochloric acid is
used to adjust the pH of the solution
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, morphine
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 _
Morphine 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
morphine. 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
other
opioids
analgesics,
benzodiazepines,
gabapentinoids, cannabis, sedatives, hypnotics, tricyclic
antidepressants, antipsychotics,
antihistamines, centrally-active anti-emetics, general anaesthetics,
tranquilisers, beta
blocker, or other central nervous system (CNS) depressants, including
alcohol, may result
in