Patient Leaflet Updated 11-Mar-2022 | Merck Sharp & Dohme (UK) Limited
Bridion 100 mg/ml solution for injection
Package leaflet: Information for the user
Bridion® 100 mg/mL solution for injection
sugammadex
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What Bridion is and what it is used for
2. What you need to know before Bridion is given
3. How Bridion is given
4. Possible side effects
5. How to store Bridion
6. Contents of the pack and other information
1. What Bridion is and what it is used for
What Bridion is
Bridion contains the active substance sugammadex. Bridion is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.
What Bridion is used for
When you have some types of operations, your muscles must be completely relaxed. This makes it easier for the surgeon to do the operation. For this, the general anaesthetic you are given includes medicines to make your muscles relax. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
Bridion is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier. It does this by combining with the rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.
2. What you need to know before Bridion is given
You should not be given Bridion
Tell your anaesthetist if this applies to you.
Warnings and precautions
Talk to your anaesthetist before Bridion is given
Children and adolescents
This medicine is not recommended for infants less than 2 years of age.
Other medicines and Bridion
Tell your anaesthetist if you are taking, have recently taken or might take any other medicines.
Bridion may affect other medicines or be affected by them.
Some medicines reduce the effect of Bridion
It is especially important that you tell your anaesthetist if you have recently taken:
Bridion can affect hormonal contraceptives
Effects on blood 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. Talk to your doctor if your progesterone levels need to be tested on the same day you receive Bridion.
Pregnancy and breast-feeding
Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding.
You may still be given Bridion, but you need to discuss it first.
It is not known whether sugammadex can pass into breast milk. Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Bridion to the mother.
Driving and using machines
Bridion has no known influence on your ability to drive and use machines.
Bridion contains sodium
This medicine contains up to 9.7 mg sodium (main component of cooking / table salt) in each mL. This is equivalent to 0.5 % of the recommended maximum daily dietary intake of sodium for an adult.
3. How Bridion is given
Bridion will be given to you by your anaesthetist, or under the care of your anaesthetist.
The dose
Your anaesthetist will work out the dose of Bridion you need based on:
The usual dose is 2-4 mg per kg body weight for adults and for children and adolescents between 2-17 years old. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.
How Bridion is given
Bridion will be given to you by your anaesthetist. It is given as a single injection through an intravenous line.
If more Bridion is given to you than recommended
As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Bridion. But even if this happens, it is unlikely to cause any problems.
If you have any further questions on the use of this medicine, ask your anaesthetist or other doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If these side effects occur while you are under anaesthesia, they will be seen and treated by your anaesthetist.
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Frequency not known
Reporting of side effects
If you get any side effects, talk to your anaesthetist or other doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bridion
Storage will be handled by healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label after ‘EXP’. The expiry date refers to the last day of that month.
Store below 30°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
After first opening and dilution, store at 2 to 8°C and use within 24 hours.
6. Contents of the pack and other information
What Bridion contains
What Bridion looks like and contents of the pack
Bridion is a clear and colourless to slightly yellow solution for injection.
It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder in Great Britain:
Marketing Authorisation Holder in UK (Northern Ireland):
Manufacturer:
For any information about this medicine, please contact:
This leaflet was last revised in February 2022
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Merck Sharp & Dohme (UK) Limited 2022. All rights reserved.
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