Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about being given this medicine,
speak to your doctor or pharmacist.
1. Why am I given SUGAMMADEX VIATRIS?
SUGAMMADEX VIATRIS contains the active ingredient sugammadex (as sodium). SUGAMMADEX
VIATRIS is used to speed up recovery of your muscles after an operation.
2. What should I know before I am given SUGAMMADEX VIATRIS?
You may already have been given SUGAMMADEX VIATRIS Injection. Your doctor will have
considered the situation carefully and decided to use it.
You must not be given SUGAMMADEX VIATRIS if you have ever had an allergic reaction
to sugammadex or any of the ingredients listed at the end of the CMI.
3. What if I am taking other medicines?
Some medicines may interfere with SUGAMMADEX VIATRIS and affect how it works.
4. How is SUGAMMADEX VIATRIS given?
The doctor will work out the dose of SUGAMMADEX VIATRIS you need based on your weight
and how much muscle relaxant is still affecting you
The usual dose is 2 - 4 mg per kg body weight. A dose of 16 mg per kg can be used
only in adults if urgent recovery from muscle relaxation is needed.
The dose of SUGAMMADEX VIATRIS for children and adolescents between 2 - 17 years old
is 2 mg per kg.
5. What should I know while given SUGAMMADEX VIATRIS?
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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. As far as it is known, SUGAMMADEX VIATRIS has no effect on alertness or
concentration.
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Looking after the medicine
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SUGAMMADEX VIATRIS is stored in the hospital according to the storage conditions on
the pack.
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6. Are there any side effects?
Like all medicines, SUGAMMADEX VIATRIS can cause side effects, but not everyone gets
them.
If the side effects occur while you are under anaesthetic, they will be seen and treated
by your anaesthetist.
Active ingredient(s):
sugammadex (as sodium)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SUGAMMADEX VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about SUGAMMADEX VIATRIS.
Where to find information in this leaflet:
1. Why am I given SUGAMMADEX VIATRIS?
SUGAMMADEX VIATRIS contains the active ingredient sugammadex (as sodium). SUGAMMADEX VIATRIS belongs to a group of medicines called Selective Relaxant Binding
Agents.
SUGAMMADEX VIATRIS 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.
SUGAMMADEX VIATRIS is used to stop the muscle relaxants working. It does this by combining
with rocuronium or vecuronium in your body.
SUGAMMADEX VIATRIS 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.
Your doctor will have explained why you are being treated with SUGAMMADEX VIATRIS.
Ask your doctor if you want any more information about this medicine.
SUGAMMADEX VIATRIS is not addictive.
2. What should I know before I am given SUGAMMADEX VIATRIS?
You may already have been given SUGAMMADEX VIATRIS Injection. Your doctor will have
considered the situation carefully and decided to use it.
Warnings
Do not use SUGAMMADEX VIATRIS if:
you are allergic to sugammadex, or any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing
or difficulty breathing, swelling of the tongue and/or throat and rash or red skin.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
Have kidney disease or have had it in the past. This is important because SUGAMMADEX
VIATRIS is removed from your body through 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).
Have allergies to any other medicines and substances such as foods, preservatives
or dyes.
Take any medicines for any other condition.
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
Tell 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 SUGAMMADEX VIATRIS if you
pregnant or breast-feeding.
SUGAMMADEX VIATRIS is not recommended for infants less than 2 years of age.
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 SUGAMMADEX VIATRIS and affect how it works.
Tell your doctor if you are taking or have recently taken:
Toremifene (used to treat breast cancer)
Fusidic acid (an antibiotic)
Flucloxacillin (an antibiotic)
Tell your doctor if you are using a hormonal
contraceptive such as the "PILL", vaginal ring, implants or
hormonal Intrauterine System (IUS).
SUGAMMADEX VIATRIS can make hormonal contraceptives less effective because it reduces
how much you get of the hormone progestogen. The amount of progestogen lost by using
SUGAMMADEX VIATRIS is about the same as missing one oral contraceptive pill.
If you are taking the PILL the same day as SUGAMMADEX VIATRIS 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 vaginal ring, implant, or
IUS), you should use an additional non-hormonal contraceptive method (such as a condom)
for the next 7 days.
Laboratory tests: In general, SUGAMMADEX VIATRIS does not have an effect on laboratory
tests. However, it may affect the results of a blood test for a hormone called progesterone.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect SUGAMMADEX VIATRIS.
4. How is SUGAMMADEX VIATRIS given?
How much is given
SUGAMMADEX VIATRIS is given as a single injection through an intravenous line.
The doctor will work out the dose of SUGAMMADEX VIATRIS 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. 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 SUGAMMADEX VIATRIS
As your doctor will be monitoring your condition carefully, it is unlikely that you
will be given too much SUGAMMADEX VIATRIS. Even if this happens, it is unlikely to
cause any problems.
5. What should I know while given SUGAMMADEX VIATRIS?
Driving or using machines
Your doctor will tell you when it is safe to drive and operate potentially dangerous
machinery.
As far as it is know, SUGAMMADEX VIATRIS has no effect on alertness or concentration.
Looking after your medicine
SUGAMMADEX VIATRIS is stored in hospital according to the storage conditions on the
pack.
6. Are there any side effects?
Like all medicines, SUGAMMADEX VIATRIS can cause side effects, but not everyone gets
them.
Side effects
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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 SUGAMMADEX VIATRIS is administered.
Signs and symptoms of allergic reactions
Allergic reactions such as 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 of 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.
Complication 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.
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If after your operation, you notice any side effects tell your doctor.
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
What SUGAMMADEX VIATRIS contains
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Active ingredient
(main ingredient)
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Sugammadex (as sodium)
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Other ingredients
(inactive ingredients)
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Hydrochloric acid
Sodium hydroxide
Water for injections
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What SUGAMMADEX VIATRIS looks like
SUGAMMADEX VIATRIS is a clear and colourless to slightly yellow solution (AUST R 377048).
SUGAMMADEX VIATRIS is available as
200 mg/2 mL pack of 10 vials
Who distributes SUGAMMADEX VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in January 2024.
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