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.
1. Why am I being treated with DBL Glyceryl Trinitrate Concentrate Injection?
DBL Glyceryl Trinitrate Concentrate Injection contains the active ingredient glyceryl
trinitrate. DBL Glyceryl Trinitrate Concentrate Injection is used to relax the muscles
surrounding blood vessels (arteries and veins) and so helps more blood and oxygen
reach the heart. It is also used to control or lower the blood pressure during some
surgical procedures.
2. What should I know before treatment with DBL Glyceryl Trinitrate Concentrate Injection?
Do not start treatment if you have ever had an allergic reaction to glyceryl trinitrate,
any medicine or food containing nitrates, 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 Glyceryl Trinitrate Concentrate Injection and
affect how it works.
4. How is DBL Glyceryl Trinitrate Concentrate Injection given?
Your doctor will decide how much DBL Glyceryl Trinitrate Concentrate Injection you
will receive. This depends on your condition and other factors, such as your age and
weight.
5. What should I know during treatment with DBL Glyceryl Trinitrate Concentrate Injection?
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Things you should do
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Remind any doctor, nurse, dentist or pharmacist who is treating you that you are being
treated with DBL Glyceryl Trinitrate Concentrate Injection.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how DBL Glyceryl
Trinitrate Concentrate Injection affects you.
This medicine may cause dizziness, light-headedness, fainting and headache in some
people. If this occurs do not drive or do anything else that could be dangerous.
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Drinking alcohol
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Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
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6. Are there any side effects?
Common side effects include headache and dizziness. Less common side effects include: rapid or irregular heart beat, bleeding easily, swelling, nausea, vomiting or abdominal
pain, pins and needles, tiredness, sleepiness, state of confusion, seizure, muscle
twitching or restlessness, muscle weakness, shoulder, neck and upper body pain, abdominal
tenderness of the right upper quadrant, dry mouth, frequent urination, shortness of
breath, vision problems.
Active ingredient(s): glyceryl trinitrate (GLIS-er-ile tri-NITE-rate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Glyceryl Trinitrate Concentrate
Injection. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about being treated with DBL Glyceryl Trinitrate
Concentrate Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Glyceryl Trinitrate Concentrate Injection?
DBL Glyceryl Trinitrate Concentrate Injection contains the active ingredient glyceryl
trinitrate. Glyceryl trinitrate belongs to a group of medicines called nitrates or vasodilators.
DBL Glyceryl Trinitrate Concentrate Injection is used to relax the muscles surrounding
blood vessels (arteries and veins) and so helps more blood and oxygen reach the heart.
It is also used to control or lower the blood pressure during some surgical procedures.
Your doctor may have prescribed glyceryl trinitrate for another reason. Ask your doctor
if you have any questions about why glyceryl trinitrate has been prescribed for you.
Glyceryl trinitrate is not addictive.
2. What should I know before treatment with DBL Glyceryl Trinitrate Concentrate Injection?
Warnings
You must not be given DBL Glyceryl Trinitrate Concentrate Injection if:
you are allergic to:
glyceryl trinitrate, or any of the ingredients listed at the end of this leaflet.
any medicine or food containing nitrates
Symptoms of an allergic reaction to glyceryl trinitrate 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.
you have any of the following conditions:
low blood pressure
increased pressure in the head (such as a recent head injury or stroke)
disease of the heart muscle or swelling around the heart
reduced red blood cells and iron stores (anaemia) or a lack of oxygen in the blood
an abnormality of haemoglobin, part of your red blood cells, responsible for carrying
oxygen.
you are taking the following medicines:
phosphodiesterase inhibitors, such as sildenafil, vardenafil or tadalafil used to
treat impotence in men and/or for treating high blood pressure in the lungs in men
and women.
riociguat used to treat high blood pressure in your lungs.
If you use these medicines together with DBL Glyceryl Trinitrate Concentrate Injection,
your blood pressure may fall to a dangerously low level.
If you are not sure whether you should be given DBL Glyceryl Trinitrate Concentrate
Injection, talk to your doctor or pharmacist.
Check with your doctor if you:
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
have or have had any other medical conditions especially the following:
liver disease
kidney disease
a recent heart attack or any heart condition for which you already use a nitrate vasodilator
drug such as patches or sprays containing a nitrate
heart disease caused by poor blood flow in the arteries of the heart
any other heart condition
any lung condition
closed angle glaucoma
take any medicines for any other condition
If you have not told your doctor or pharmacist about any of the above, tell them before
you are given DBL Glyceryl Trinitrate Concentrate 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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Glyceryl trinitrate is not recommended for use during pregnancy. If there is a need
to consider glyceryl trinitrate during your pregnancy, your doctor or pharmacist will
discuss with you the benefits and risks of using it.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Glyceryl trinitrate is not recommended while you are breastfeeding. It is not known
if glyceryl trinitrate is excreted into breast-milk.
Use in Children
Glyceryl trinitrate is not recommended for use in children, as there is not enough
information on its effects in children.
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 and DBL Glyceryl Trinitrate Concentrate Injection may interfere with
each other and affect how they work. These include:
aspirin and other non-steroidal anti-inflammatory medicines
morphine, a medicine used for pain
some medicines for depression such as tricyclic antidepressants
some medicines that block nerve conduction to muscles such as anticholinergics
heparin, a medicine used to prevent blood clots
some medicines used to treat high blood pressure or heart problems
ergotamine, methysergide and dihydroergotamine; medicines used to prevent or treat
migraine headaches
tranquillisers, medicines used to treat some mental illnesses
some medicines for impotence such as sildenafil
riociguat used to treat high blood pressure in your lungs.
These medicines may be affected by glyceryl trinitrate or may affect how well it works. You may need
different amounts of your medicines, or you may need to take or use different medicines.
Your doctor or pharmacist will advise you.
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 Glyceryl Trinitrate Concentrate
Injection.
4. How is DBL Glyceryl Trinitrate Concentrate Injection given?
How much is given
Due to variations in the response of individual patients to the drug, the dose of
glyceryl trinitrate varies. Your doctor will decide what dose you will receive. This
depends on your condition and other factors, such as your age or weight.
How it is given
DBL Glyceryl Trinitrate Concentrate Injection must be diluted and given as a slow
infusion or ‘drip’ injection into your veins (intravenously). It should not be mixed
with other drugs.
If you are given too much DBL Glyceryl Trinitrate Concentrate Injection
As DBL Glyceryl Trinitrate Concentrate Injection is given to you in hospital under
the supervision of your doctor, it is very unlikely that you will receive too much.
However, if you experience severe side effects tell your doctor immediately.
Symptoms of a glyceryl trinitrate overdose include the side effects listed below in
Section 6. Are there any side effects? but are usually of a more severe nature.
Ask your doctor or pharmacist if you have any concerns.
If you think that you have been given too much DBL Glyceryl Trinitrate Concentrate
Injection, you may need urgent medical attention.
You should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), 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 Glyceryl Trinitrate Concentrate Injection?
Things you should do
Remind any doctor, nurse, dentist or pharmacist who is treating you that you are being
treated with DBL Glyceryl Trinitrate Concentrate Injection.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Glyceryl
Trinitrate Concentrate Injection affects you.
DBL Glyceryl Trinitrate Concentrate Injection may cause dizziness, light-headedness,
fainting and headache in some people.
Make sure you know how glyceryl trinitrate affects you before you drive a car, operate
machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
If this occurs do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink alcohol, dizziness or light-headedness may be worse.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less common side effects
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 Glyceryl Trinitrate Concentrate Injection contains
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Active ingredient
(main ingredient)
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glyceryl trinitrate
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Other ingredients
(inactive ingredients)
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ethanol absolute
propylene glycol
water for injections
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DBL Glyceryl Trinitrate Concentrate Injection does not contain lactose, sucrose, gluten,
tartrazine or any other azo dyes.
Do not use this medicine if you are allergic to any of these ingredients.
What DBL Glyceryl Trinitrate Concentrate Injection looks like
DBL Glyceryl Trinitrate Concentrate Injection is a clear, practically colourless solution
(Aust R 16341).
DBL Glyceryl Trinitrate Concentrate Injection is available in the following strength
and pack:
50mg in 10mL, 5 x 10mL ampoules
How is DBL Glyceryl Trinitrate Concentrate Injection stored
DBL Glyceryl Trinitrate Concentrate Injection will be stored in the pharmacy or on
the ward. The injection is kept in a cool dry place, protected from light, where the
temperature stays below 25°C.
Who distributes DBL Glyceryl Trinitrate Concentrate Injection
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in June 2022.
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© Pfizer Australia Pty Ltd 2022