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 SUGAMMADEX-TEVA?
SUGAMMADEX-TEVA contains the active ingredient sugammadex (as sodium). SUGAMMADEX-TEVA
is used to speed up recovery of your muscles after an operation.
2. What should I know before I use SUGAMMADEX-TEVA?
Do not use if you have ever had an allergic reaction to sugammadex 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 SUGAMMADEX-TEVA and affect how it works.
4. How do I use SUGAMMADEX-TEVA?
SUGAMMADEX-TEVA is given as a single injection through an intravenous line. The doctor
will work out the dose of SUGAMMADEX-TEVA you need based on your weight and how much
muscle relaxant is still affecting you.
5. What should I know while using SUGAMMADEX-TEVA?
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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-TEVA has no effect on alertness or concentration.
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Storage
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SUGAMMADEX-TEVA 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-TEVA 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.
Solution for Injection
Active ingredient(s): sugammadex (as sodium)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using SUGAMMADEX-TEVA. 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 SUGAMMADEX-TEVA.
Where to find information in this leaflet:
1. Why am I using SUGAMMADEX-TEVA?
SUGAMMADEX-TEVA contains the active ingredient sugammadex (as sodium). SUGAMMADEX-TEVA belongs to a group of medicines called Selective Relaxant Binding
Agents.
SUGAMMADEX-TEVA 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-TEVA is used to stop the muscle relaxants working. It does this by combining
with rocuronium or vecuronium in your body.
SUGAMMADEX-TEVA 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-TEVA.
2. What should I know before I use SUGAMMADEX-TEVA?
Warnings
Do not use SUGAMMADEX-TEVA if:
you are allergic to sugammadex, 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 any other medical conditions including present or past kidney disease, diseases
known to increase risk of bleeding, present or past liver disease and fluid retention
(oedema)
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
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 SUGAMMADEX-TEVA if you are
pregnant or breast-feeding.
Children
SUGAMMADEX-TEVA is not recommend for infants less than 2 years of age.
Laboratory tests
In general, SUGAMMADEX-TEVA 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.
SUGAMMADEX-TEVA may interfere with some medicines and affect how they work.
SUGAMMADEX-TEVA 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-TEVA is about the same as missing one oral contraceptive Pill.
If you are taking the PILL the same day as SUGAMMADEX-TEVA 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.
Medicines that may
reduce
the effect of SUGAMMADEX-TEVA include:
toremifene (used to treat breast cancer)
fusidic acid (an antibiotic)
flucloxacillin (an antibiotic)
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-TEVA.
4. How do I use SUGAMMADEX-TEVA?
How much to use
SUGAMMADEX-TEVA is given as a single injection through an intravenous line.
The doctor will work out the dose of SUGAMMADEX-TEVA 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 SUGAMMADEX-TEVA
As your doctor will be monitoring your condition carefully, it is unlikely that you
will be given too much SUGAMMADEX-TEVA. Even if this happens, it is unlikely to cause
any problems.
5. What should I know while using SUGAMMADEX-TEVA?
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 known, SUGAMMADEX-TEVA has no effect on alertness or concentration.
Storage
SUGAMMADEX-TEVA 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, anaesthetist or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor, anaesthetist 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.
7. Product details
This medicine is only available with a doctor's prescription.
What SUGAMMADEX-TEVA contains
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Active ingredient
(main ingredient)
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Sugammadex (as sodium) 200 mg or 500 mg
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Other ingredients
(inactive ingredients)
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Hydrochloric acid
Sodium hydroxide
Water for Injections
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Do not take this medicine if you are allergic to any of these ingredients.
What SUGAMMADEX-TEVA looks like
SUGAMMADEX-TEVA is a clear, colourless to slightly yellow-brown solution for injection.
SUGAMMADEX-TEVA is available as:
200 mg/2 mL pack of 10 vials (Aust R 375461)
500 mg/5 mL pack of 10 vials (Aust R 375460)
Not all strengths may be marketed
Who distributes SUGAMMADEX-TEVA
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
Teva Pharma (New Zealand) Ltd
Auckland, New Zealand
This leaflet was prepared in March 2023.