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 treated with DBL Morphine Sulfate Injection?
DBL Morphine Sulfate Injection contains the active ingredient morphine sulfate pentahydrate.
DBL Morphine Sulfate Injection is a pain reliever that belongs to a group of medicines
called opioid analgesics. It is most commonly used for short-term relief of severe
pain. It may also be used just before or during an operation to help the anaesthetic
work better.
2. What should I know before treatment with DBL Morphine Sulfate Injection?
You should not be given DBL Morphine Sulfate Injection if you have ever had an allergic
reaction to morphine 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.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Morphine Sulfate Injection and affect how it
works.
4. How is DBL Morphine Sulfate Injection given?
Your doctor will decide what dose of morphine you will receive. This depends on your
condition and other factors, such as your weight. It may be given by an injection
or infusion, or you may be given a "patient-controlled analgesia" (PCA) device to
use.
5. What should I know during treatment with DBL Morphine Sulfate Injection?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you have been given morphine.
If you become pregnant while you are being treated with morphine, tell your doctor
immediately.
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Things you should not do
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Do not stop using this medicine suddenly. If you have been using morphine for more
than two weeks, you may experience unpleasant feelings if you stop morphine suddenly.
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Driving or using machines
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DBL Morphine can affect driving and safe use of machinery and tools. Morphine may
cause drowsiness and impair coordination.
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Drinking alcohol
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Do not drink alcohol while you are being treated with morphine.
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Looking after your medicine
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If you are being given DBL Morphine Sulfate Injection while in hospital, it will be
stored in the pharmacy or on the ward. Store below 25°C.
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6. Are there any side effects?
Common side effects are mild and usually short lived. These include drowsiness, dizziness
or unsteadiness, light-headedness, sweating or flushing, nausea or vomiting, constipation,
mood changes. If you experience any signs of an allergic reaction, severe drowsiness,
slow or troubled breathing, severe weakness, agitation, hallucinations, unconsciousness,
seizures, slow or rapid heart beat, difficulty urinating, severe skin rash/mouth sores
or severe upper abdominal pain, you may need urgent medical attention or hospitalisation.
Repeated use of morphine can result in it becoming less effective (you become tolerant
to it) and it can also lead to dependence, abuse and addition, which may result in
life-threatening overdose.
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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 breathing problems
Morphine injection can cause serious, 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
and after a dose increase, if you are older, or if you 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 with other medicines that can make you feel very drowsy or increase
your risk of decreased awareness, serious breathing problems, coma or death. Such
medicines include: sleeping tablets (e.g. benzodiazepines), other pain relievers,
antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and
pregabalin), cannabis and alcohol. Your doctor will minimise the dose and duration
of use of morphine (and/or the other drugs) and monitor you for signs and symptoms
of breathing difficulties and sedation. You must not drink alcohol while using morphine.
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Active ingredient(s):
morphine sulfate pentahydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Morphine Sulfate Injection.
You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using DBL Morphine Sulfate
Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Morphine Sulfate Injection?
DBL Morphine Sulfate Injection contains the active ingredient morphine sulfate pentahydrate.
DBL Morphine Sulfate Injection is a pain reliever that belongs to a group of medicines
called opioid analgesics. Morphine acts in the brain and spinal cord.
DBL Morphine Sulfate Injection is used most commonly for short-term 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 morphine has been prescribed for
you. Your doctor may have prescribed morphine for another reason.
2. What should I know before treatment with DBL Morphine Sulfate Injection?
This medicine has been prescribed for you and should not be given to anyone else.
Before starting treatment and regularly during treatment, your doctor will discuss
with you what you expect during treatment with morphine (in terms of pain control),
when and for how long morphine will be given, when it should be stopped and how to
do this safely.
Morphine should not be used for longer than necessary.
Repeated use of morphine can result in it becoming less effective (you become tolerant
to it) and it can also lead to dependence, abuse and addition, which may result in
life-threatening overdose.
The signs and symptoms of this are explained further down in this document.
Warnings
Do not use DBL Morphine Sulfate Injection if you:
are allergic to any medicine containing morphine, any of the ingredients listed at
the end of this leaflet, or any other similar medicines.
Symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Always check the ingredients to make sure you can use this medicine.
have severe asthma or severe lung disease such bronchitis (i.e. coughing spells with
by thick phlegm and breathlessness), emphysema (which leaves you struggling for breath)
or COPD (Chronic Obstructive Pulmonary Disease), which causes difficulty breathing
difficulty, mucus or sputum production and wheezing.
have shallow or difficulty breathing
are suffering from alcoholism or delirium tremens ("DTs", "the shakes")are undergoing
treatment with monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine,
moclobemide or selegiline), or have stopped MAO inhibitor treatment during the last
fourteen (14) days
have an irregular heartbeat (arrhythmia), or heart flutter
have heart failure after lung disease (cor pulmonale)
have severe liver or kidney problems
have severe decreased level of consciousness
have diabetic acidosis where there is danger of coma
have had recent biliary tract surgery or biliary colic (which causes severe stomach
cramps)
have obstruction of the gastrointestinal tract or require abdominal surgery
have a condition where the small bowel does not work properly or is blocked (paralytic
ileus)
have severe diarrhoea, or diarrhoea caused by antibiotic-induced large bowel inflammation
or poisoning
have a rare adrenal gland tumour near the kidney (phaeochromocytoma)
have a severely deformed spine
are suffering from mental illness brought on by an infection
have a head injury, brain tumour or increased pressure in the head/brain/spinal cord
or are unconscious.
are having fits/convulsions
have sickle cell disease (an inherited red blood cell disorder)
Check with your doctor if you:
have, or have had, any other medical conditions, especially the following:
epilepsy, convulsions, fits or seizures
underactive thyroid gland (hypothyroidism) and/or adrenal gland (Addison's disease)
enlarged prostate or problems with urination
fast heart beat (tachycardia)
low blood pressure
liver problems
kidney problems
any bowel problems or ulcerative colitis
problems with your bile duct or pancreas
myasthenia gravis
snoring or sleep apnoea (you temporarily stop breathing or have difficulty breathing
while asleep)
feel weak or very run down
long-standing pain not related to cancer
unexplained increase in pain, increased levels of pain with increasing opioid medication
or sensitivity not associated with the original pain.
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have ever developed a severe skin rash or skin peeling, blistering
and/or mouth sores after being given morphine or other opioids.
Acute generalised exanthematous pustulosis (AGEP) has been reported in association
with morphine treatment. Symptoms usually occur within the first 10 days of treatment.
Sleep-related breathing disorders
DBL Morphine Sulfate Injection can cause sleep-related breathing problems such as
sleep apnoea (breathing pauses during sleep), which causes low oxygen levels in your
blood. The symptoms can include breathing pauses during sleep, night awakening due
to shortness of breath, difficulties staying asleep or excessive drowsiness during
the day. If you or another person observe these symptoms, contact your doctor. A dose
reduction may be considered by your doctor.
Premature infants
DBL Morphine Sulfate Injection must not be given to premature infants or during labour
for delivery of premature infants.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. As morphine
passes into breast milk, breastfeeding is not recommended while you are being given
morphine.
Your doctor or pharmacist can discuss with you the risks and benefits involved.
If you have not told your doctor or pharmacist about any of the above, tell them before
you are given DBL Morphine Sulfate Injection.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Addiction
Taking this medicine regularly, especially for a long period of time, can lead to
addiction.
Talk with your doctor before taking this medicine if you:
are using drugs or have used drugs in the past, especially amphetamines
are or have ever been addicted to opioids, alcohol, prescription medicines or illegal
drugs
have previously suffered withdrawal symptoms such as agitation, anxiety, shaking or
sweating, when you have stopped taking alcohol or drugs.
The risk of becoming dependent or addicted varies from person to person. You may have
a greater risk of becoming dependent or addicted to morphine if:
you or anyone in your family have ever abused or been dependent on alcohol, prescription
medicines or illegal drugs
you are a smoker, or use vapes
you have ever had problems with your mood (depression, anxiety, or a personality disorder)
or have been treated by a psychiatrist for other mental illnesses.
Addiction can make you feel that you are no longer in control of how much medicine
you need to use of how often you need to use it.
You can become addicted to morphine even if you use it exactly as prescribed. Morphine
may become habit forming causing mental and physical dependence. If abused, it may
become less able to reduce your pain.
Do not try to inject morphine obtained from tablets or patches. This can cause serious
side effects and can result in death.
Physical dependency
As with all other opioid containing products, your body may become used to you using
morphine. Using it for a long time (i.e. more than two weeks) may result in physical
dependence. Physical dependence means that you may experience withdrawal symptoms
if you stop using morphine suddenly, so it is important to use it exactly as directed
by your doctor.
Dependence can make you feel that you are no longer in control of how much medicine
you need to use of how often you need to use it.
If you notice any of the following signs whilst using DBL Morphine Sulfate Injection,
it could be a sign that you have become dependent or addicted:
you need to use morphine for longer than advised by your doctor
you need to use more than the recommended dose
you are using morphine for reasons other than prescribed, for instance, ‘to stay calm’
or ‘help you sleep’
you have made repeated, unsuccessful attempts to quit or control the use of morphine
when you stop using morphine you feel unwell, and you feel better once using the medicine
again (‘withdrawal effects’).
If you notice any of these signs, speak to your doctor to discuss the best treatment
pathway for you, including when it is appropriate to stop and how to stop safely.
Tolerance
Repeated use of opioids can result in the drug being less effective (you become accustomed
to it, known as tolerance). If this happens, a higher dose of morphine may be needed
to maintain the same effect, which may result in life-threatening overdose.
Speak with your doctor, nurse or pharmacist if you feel you need more morphine to
get the same level of pain relief, as this may mean you are becoming tolerant to the
effects of morphine or are becoming addicted to it.
Your doctor will discuss your treatment and may change your dose or switch you to
an alternative pain reliever.
Withdrawal
Continue using your medicine for as long as your doctor tells you. If you stop using
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
nervousness, restlessness, agitation, irritability, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, feeling or being sick or having diarrhoea
increased heart rate, breathing rate or pupil size
feeling your heartbeat (palpitations), increased blood pressure,
watery eyes, runny nose, shaking, chills or yawning
increased sweating or body temperature
hairs standing on end.
muscle twitching
seizures.
Morphine given to the mother during labour can cause breathing problems and signs
of withdrawal in the newborn.
Your doctor will discuss with you how to gradually reduce your dose before stopping
the medicine. It is important that you do not stop using the medicine suddenly as
you will be more likely to experience withdrawal symptoms.
The risk of these side effects can increase with a higher dose and longer duration
of use. However, it is also important to keep your pain under control. Your doctor
can advise you on how to manage this.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with DBL Morphine Sulfate Injection and affect how it
works. These include:
antidepressants or medicines for anxiety disorders, such as:
selective serotonin reuptake inhibitors (SSRIs) i.e. sertraline, fluvoxamine, fluoxetine,
paroxetine, citalopram, escitalopram.
serotonin and norepinephrine reuptake inhibitors (SNRIs) i.e. venlafaxine, desvenlafaxine,
duloxetine
tricyclic antidepressants (TCAs) i.e. amitriptyline, nortriptyline, clomipramine,
imipramine, amoxapine, doxepin, dosulepin/dothiepen.
monoamine oxidase inhibitors (MAOIs) i.e. moclobemide, phenelzine, tranylcypromine.
selegiline, a MAO used to treat Parkinson's disease
medicines use for migraine (triptans) i.e. sumatriptan, rizatriptan, eletriptan, zolmitriptan,
naratriptan
medicines used to prevent or treat nausea and vomiting (5-HT3 receptor antagonists
i.e. ondansetron, granisetron, palonosetron, tropisetron nausea) or domperidone, metoclopramide
cimetidine, famotidine or nizatidine, medicines used to treat stomach or duodenal
ulcers, or reflux
benzodiazepines and other medicines to treat anxiety, acute stress reactions, agitation,
tremor i.e. diazepam, alprazolam, temazepam, nitrazepam, lorazepam
other medicines which may make you drowsy such as sleeping tablets, tablets to calm
your nerves, sedatives, tranquilisers, general anaesthetics, hypnotics and muscle
relaxants
anti-diarrhoeal medications e.g. loperamide and kaolin
medicines to treat mental disorders (antipsychotics) i.e. aripiprazole, chlorpromazine,
clozapine, haloperidol, olanzapine, periciazine, quetiapine, risperidone, trifluoperazine,
ziprasidone
other opioid analgesics or strong painkillers e.g. pentazocine or buprenorphine
some antihistamines, which can help with allergy, hay fever or asthma
diuretics ("fluid tablets"), which help remove extra fluid from your body
some heart medications e.g. beta blockers (such as atenolol, bisoprolol, propanolol
or metoprolol) or mexiletine (to control heart rhythm)
medicines that lower your blood pressure (antihypertensives)
warfarin, a medicine used to thin the blood
medicines used to reduce risk of blood clots or stroke e.g. clopidogrel, prasugrel
and ticagrelor
zidovudine or ritonavir, medicines used to treat HIV infection
medicines used for seizures or nerve pain e.g. gabapentin and pregabalin
cannabis (marijuana) or tobacco
atropine (can be used before/during surgery, during CPR or for certain types of poisoning)
some medicines used to treat infections e.g. rifampicin and ciprofloxacin.
paracetamol
These medicines may be affected by morphine or may affect how well it works. You may
need different amounts of your medicine, or you may need to take different medicines.
Your doctor or pharmacist will advise you.
Your doctor will minimise the dose and duration of use; and monitor you for signs
and symptoms of breathing difficulties and sedation.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Morphine Sulfate Injection.
4. How is DBL Morphine Sulfate Injection given?
How much is given
Your doctor will decide what dose of morphine you will receive. This depends on your
condition and other factors, such as your weight.
How is it given
Your doctor or nurse will usually give DBL Morphine Sulfate Injection to you.
DBL Morphine Sulfate Injection can be given as:
an injection into a muscle
a slow injection into a vein
an injection under the skin, or
by a method called patient-controlled analgesia (PCA).
This method allows you, the patient, to control the amount of morphine you wish to
receive. On experiencing pain, you can press a button, which allows a dose of morphine
to be administered to you. To prevent you from receiving too much morphine, there
is a "lockout" period built into the pump which prevents continuous injection of morphine.
Your doctor will decide the most appropriate way for you to be given DBL Morphine
Sulfate Injection.
PCA should not be used for patients under 6 years old with poor cognition (issues
with language, memory and thinking).
If you use too much (overdose)
If you think that you have received too much morphine, you may need urgent medical
attention.
If you or someone else receive too much (overdose), and experience one or more of
the symptoms below, call triple zero (000) for an ambulance. Keep the person awake
by talking to them or gently shaking them every now and then. You should follow the
above steps even if someone other than you has accidentally used morphine that was
prescribed for you.
People who overdose on morphine may have breathing problems leading to unconsciousness,
heart attack or death.
Symptoms of an overdose may include:
slow, unusual or difficult breathing
drowsiness, confusion, dizziness or unconsciousness
severe weakness
slow or weak heartbeat
nausea or vomiting
pneumonia from inhaling vomit (with breathlessness, cough and fever)
convulsions or fits
pale and cold skin.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know during treatment with DBL Morphine Sulfate Injection?
As morphine may cause nausea and vomiting, your doctor is likely to prescribe medicine
for you to take/receive before the morphine, to stop you feeling sick.
Morphine may also cause constipation, so your doctor is likely to prescribe laxatives
to prevent this from happening.
Things you should do
If you are about to be started on any new medicine, tell your doctor, dentist and
pharmacist that you are being given morphine.
Tell any doctors, dentists and pharmacists who treat you that you are being given
morphine.
If you plan to have surgery that needs a general anaesthetic, tell the surgeon or
anaesthetist that you are being given morphine. It may affect other medicines used
during surgery.
If you become pregnant while you are being treated with morphine, tell your doctor
or pharmacist immediately.
Tell your doctor, pharmacist or nurse if you have any concerns about being given morphine.
Things you should not do
Do not use DBL Morphine Sulfate Injection to treat any other complaints unless your
doctor tells you to.
Do not give DBL Morphine Sulfate Injection to anyone else, even if they have the same
condition as you.
Do not stop using DBL Morphine Sulfate Injection or lower the dosage without checking
with your doctor or pharmacist. If you have been using DBL Morphine Sulfate Injection
for more than two weeks, you may experience unpleasant feelings if you stop suddenly.
Your doctor will probably want you to gradually reduce the amount of morphine you
are using, before stopping it completely.
Do not take any other medicines, whether they are prescription or over-the-counter
medicines, unless they have been prescribed or recommended by a doctor or pharmacist
who knows you are being given morphine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Morphine
Sulfate Injection affects you.
DBL Morphine Sulfate Injection may cause drowsiness and impairment of coordination
in some people. Do not do anything else that could be dangerous if you are drowsy
or feeling uncoordinated.
Make sure you know how you react to morphine.
DBL Morphine has the potential to affect driving and has an associated risk with road
safety.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol while you are undergoing treatment with morphine, unless otherwise
advised by your doctor or pharmacist, as drowsiness and coordination may be worse.
Looking after your medicine
If you are being given DBL Morphine Sulfate Injection while in hospital, it will be
stored in the pharmacy or on the ward.
DBL Morphine Sulfate Injection should be stored in a cool, dry place, protected from
light, where the temperature stays below 25°C.
Do not store DBL Morphine Sulfate Injection or any other medicine in the bathroom
or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
When to discard your medicine
Do not use this medicine after the expiry date.
If your doctor tells you to stop using DBL Morphine Sulfate Injection or the expiry
date has passed, take it to any pharmacy for safe disposal.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Do not stop using morphine without first talking to your doctor or pharmacist.
Common side effects
Serious side effects
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Serious side effects
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What to do
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any signs of an allergic reaction to morphine such as:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
severe drowsiness
slow or troubled breathing
severe weakness
agitation
hallucinations (imagining things)
seizures (fits, convulsions)
unconsciousness
slow or rapid heartbeat
palpitations (skipped, extra or irregular heartbeat)
difficulty in urinating
blistering, widespread scaly skin or pus-filled spots together with fever
severe upper abdominal pain possibly radiating to the back, with nausea, vomiting
or fever
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these side effects.
These are very serious side effects. You may need urgent medical attention or hospitalisation.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Morphine Sulfate Injection contains
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Active ingredient
(main ingredient)
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Morphine sulfate pentahydrate
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Other ingredients
(inactive ingredients)
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Sodium chloride
Hydrochloric acid (to adjust pH)
Water for injections
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Do not use this medicine if you are allergic to any of these ingredients.
DBL Morphine Sulfate Injection does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
DBL Morphine Sulfate injection does not contain any antioxidant or preservatives.
What DBL Morphine Sulfate Injection looks like
DBL Morphine Sulfate Injection is a clear slightly yellow or clear yellow solution
in a coloured glass ampoule.
It is available in the following strengths:
5 mg/1 mL AUST R 121754
10 mg/1 mL AUST R 101240
15 mg/1 mL AUST R 101243
30 mg/1 mL AUST R 121755
Not all presentations may be marketed.
Sponsor
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in September 2024
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© Pfizer Australia Pty Ltd 2021