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 using BRIDION?
BRIDION contains the active ingredient sugammadex sodium. BRIDION is used to speed
up recovery of your muscles after an operation.
2. What should I know before I use BRIDION?
Do not use if you have ever had an allergic reaction to BRIDION 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 BRIDION and affect how it works.
4. How do I use BRIDION?
BRIDION is given as a single injection through an intravenous line. The doctor will
work out the dose of BRIDION you need based on your weight and how much muscle relaxant
is still affecting you.
5. What should I know after being given BRIDION?
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Driving or using machines
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Your doctor will tell you when it is safe to drive and operate potentially dangerous
machinery.
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6. Are there any side effects?
Like all medicines, BRIDION can cause side effects, but not everyone gets them.
If these side effects occur while you are under anaesthetic, they will be seen and
treated by your anaesthetist.
Active ingredient(s):
sugammadex sodium
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BRIDION. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using BRIDION.
Where to find information in this leaflet:
1. Why am I using BRIDION?
BRIDION contains the active ingredient sugammadex sodium. BRIDION is one of a group of medicines called Selective Relaxant Binding Agents.
BRIDION is used to speed up recovery of your muscles after an operation.
During some operations, your muscles must be completely relaxed. This makes it easier
for the surgeon to perform the operation. To make your muscles relax, the general
anaesthetic includes muscle relaxants such as rocuronium or vecuronium. Because the
muscles needed for breathing also become relaxed, you will need help with your breathing
(artificial ventilation) during and after your operation until you can breathe on
your own again.
BRIDION is used to stop the muscle relaxants working. It does this by combining with
rocuronium or vecuronium in your body.
BRIDION is given to speed up your recovery from the muscle relaxant - for example,
at the end of an operation to allow you to breathe normally earlier.
You may already have been given BRIDION Injection. Your doctor will have considered
the situation carefully and decided to use it.
Your doctor will have explained why you are being treated with BRIDION.
Ask your doctor if you want any more information about this medicine.
BRIDION is not addictive.
2. What should I know before I use BRIDION?
Warnings
Do not use BRIDION if:
you are allergic to sugammadex sodium, or any of the ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the tongue and/or throat
rash or red skin
Check with your doctor if you:
have kidney disease or have had it in the past. This is important because BRIDION
is removed from your body by the kidneys.
have any diseases known to give an increased risk of bleeding (disturbance of blood
clotting).
have liver disease or have had it in the past.
have fluid retention (oedema).
take any medicines for any other condition
have allergies to any other medicines.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of using BRIDION if you are pregnant
or breast-feeding.
Children
BRIDION is not recommended for infants less than 2 years of age.
Laboratory tests
In general, BRIDION does not have an effect on laboratory tests. However it may affect
the results of a blood test for a hormone called progesterone.
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 BRIDION and affect how it works.
Medicines that may
reduce
the effect of BRIDION include:
toremifene (used to treat breast cancer)
fusidic acid (an antibiotic)
flucloxacillin (an antibiotic)
BRIDION may reduce the effect of hormonal contraceptives
Tell your doctor if you are using a hormonal contraceptive such as the "PILL", vaginal
ring, implants or hormonal Intrauterine System (IUS).
BRIDION can make hormonal contraceptives less effective because it reduces how much
you get of the hormone progestogen. The amount of progestogen lost by using BRIDION
is about the same as missing one oral contraceptive Pill.
If you are taking the PILL the same day as BRIDION is given to you, follow the instructions
for a missed dose in the Pill's package insert.
If you are using OTHER hormonal contraceptives (such as a vaginal ring, implant or
IUS), you should use an additional non-hormonal contraceptive method (such as a condom)
for the next 7 days.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BRIDION.
4. How do I use BRIDION?
How much to use
BRIDION is given as a single injection through an intravenous line. The doctor will
work out the dose of BRIDION you need based on:
your weight
how much muscle relaxant is still affecting you
The usual dose is 2 - 4 mg per kg body weight for patients 2 years of age and older.
A dose of 16 mg per kg can be used only in adults if urgent recovery from muscle relaxation
is needed.
If you are given too much BRIDION
As your doctor will be monitoring your condition carefully, it is unlikely that you
will be given too much BRIDION. Even if this happens, it is unlikely to cause any
problems.
5. What should I know after being given BRIDION?
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BRIDION
affects you.
Your doctor will tell you when it is safe to drive and operate potentially dangerous
machinery. As far as it is known, BRIDION has no effect on alertness or concentration.
Looking after your medicine
BRIDION is stored in the hospital according to the storage conditions on the pack.
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.
Serious side effects
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Serious side effects
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What to do
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Signs and symptoms of lung problems:
Cough.
Airway difficulties that may include coughing or moving as if you are waking or taking
a breath.
Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in
patients with a history of lung problems.
Signs and symptoms of heart problems:
Decreased blood pressure due to the procedure.
Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur
when BRIDION is administered.
Signs and symptoms of allergic reactions:
Allergic reactions such as a rash or red skin, swelling of the tongue and/or throat,
shortness of breath, changes in blood pressure or heart rate, sometimes resulting
in a serious decrease in blood pressure. Severe allergic or allergic-like reactions
can be life threatening. Allergic reactions were reported more commonly in healthy,
conscious volunteers.
Signs and symptoms of muscle problems:
Return of muscle relaxation after the operation.
Signs and symptoms problems in other organs:
Light anaesthesia - you may start to come out of deep sleep and need more anaesthetic.
This might cause you to move or cough at the end of the operation.
Complications during your procedure such as changes in heart rate, coughing or moving.
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If these side effects occur while you are under anaesthetic, they will be seen and
treated by your anaesthetist.
If after your operation, you notice any side effects tell your doctor.
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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
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What BRIDION contains
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Active ingredient
(main ingredient)
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sugammadex sodium
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Other ingredients
(inactive ingredients)
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hydrochloric acid and/or sodium hydroxide for pH adjustment
water for Injections
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Do not take this medicine if you are allergic to any of these ingredients.
What BRIDION looks like
BRIDION is a colourless to slightly yellow solution for injection.
BRIDION is available as
200 mg/2 mL pack of 10 vials (AUST R 147716)
500 mg/5 mL pack of 10 vials (AUST R 148263)
Who distributes BRIDION
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road,
Macquarie Park, NSW 2113
This leaflet was prepared in November 2023.
RCN: 000024775-AU; 000026172-AU
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.