Morphine Sulfate

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Morphine sulfate pentahydrate 5 mg/mL;  

Available from:

Medsurge Pharma Limited

Dosage:

5 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Morphine sulfate pentahydrate 5 mg/mL   Excipient: Hydrochloric acid Nitrogen Sodium chloride Water for injection

Prescription type:

Class B1 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:

Package - Contents - Shelf Life: Ampoule, glass, Type 1 coloured, 1mL - 5 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2019-08-15

Patient Information leaflet

NZ CMI EDITION 1.0 OCTOBER 2020
1
MORPHINE SULFATE
_MORPHINE SULFATE PENTAHYDRATE _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Morphine
Sulfate
injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was last
updated on the date listed on the final
page. More recent information on the
medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK TO
YOUR PHARMACIST OR DOCTOR TO OBTAIN
THE MOST UP-TO-DATE INFORMATION ON
THE MEDICINE.
Those updates may contain important
information about the medicine and its
use of which you should be aware. All
medicines have risks and benefits.
Your doctor has weighed the risks of
you having Morphine Sulfate injection
against the benefits they expect it will
give you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT MORPHINE SULFATE
INJECTION IS USED FOR
Morphine is a pain reliever that belongs
to a group of medicines called opioid
analgesics.
Morphine acts in the brain and spinal
cord.
It is used most commonly for relief of
severe pain. It may also be used just
before or during an operation to help
the anaesthetic work better.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another purpose.
Morphine
may
produce
physical
dependency if used for a long time (i.e.
more
than
two
weeks).
Physical
dependency
means
you
may
experience unpleasant feelings if you
stop morphine suddenly.
However, it is also important to keep
your pain under control. Your doctor
can advise you on how to manage this.
This medicine is only available with a
doctor's prescription.
BEFORE YOU USE
MORPHINE SULFATE
INJECTION
_WHEN _
_YOU _
_MUST _
_NOT _
_USE _
_MORPHINE SULFATE INJECTION _
_ _
DO
NOT
HAVE
MORPHINE
SULFATE
INJECTION IF YOU HAVE EVER HAD AN
ALLERGIC REACTION AFT

Summary of Product characteristics

MORPHINE SULFATE
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Edition 3.0 July 2022
Page 1 of 23
NEW ZEALAND DATA SHEET
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 opioid 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 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 using
morphine (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
1
PRODUCT NAME
MORPHINE SULFATE 2 mg/1 mL (MEDSURGE) solution for injection
MORPHINE SULFATE 5 mg/1 mL (MEDSURGE) solutio