100 mg/mL
Sugammadex
Consumer Medicine Information
What BRIDION is used for
BRIDION belongs to a group of medicines called Selective Relaxant Binding Agents. It 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 Esmeron and Norcuron. 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 Esmeron or Norcuron 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.
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.
Before you are given BRIDION
You may already have been given BRIDION Injection. Your doctor will have considered the situation carefully and decided to use it.
When you must not be given it
You must not be given BRIDION if:
you are allergic to sugammadex or have an allergy to 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
rash or red skin
Before you are given it
Tell 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.
Tell your doctor if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Tell your doctor if you are pregnant or might be pregnant or are breast-feeding.
Your doctor will discuss the risks and benefits of using BRIDION if you are pregnant or breast-feeding.
If you have not told your doctor about any of the above, tell them before you are given BRIDION.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
BRIDION may affect other medicines or be affected by them.
Tell your doctor if you are taking or have recently taken:
toremifene (used to treat breast cancer)
fusidic acid (an antibiotic)
flucloxacillin (an antibiotic)
These medicines can reduce the effect of BRIDION.
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.
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 and some blood clotting tests.
How BRIDION is given
BRIDION is given as an injection into your vein (intravenously) as a single injection.
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. A higher dose may be given if the doctor wants you to recover faster.
The dose of BRIDION is similar in adults and children.
Overdose
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.
After having BRIDION
Things to be careful of
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.
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.
A temporary unpleasant taste in your mouth
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
Your muscles stay relaxed for longer than expected
Allergic reactions such as a rash or red skin, swelling of the tongue and/or throat, 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.
If after your operation, you notice any side effects tell your doctor.
Tell your doctor if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients.
Ask your doctor to answer any questions you may have.
Storage
BRIDION is stored in the hospital according to the storage conditions on the pack.
Product description
What it looks like
BRIDION is a colourless to slightly yellow solution for injection.
BRIDION is available as
200 mg/2 mL pack of 10 vials
500 mg/5 mL pack of 10 vials
Ingredients
It contains 200mg or 500mg sugammadex as the active ingredient.
It also contains hydrochloric acid and/or sodium hydroxide for pH adjustment and Water for Injections.
Distributor
In Australia:
Merck Sharp & Dohme (Australia) Pty Limited
54-68 Ferndell St
South Granville 2142 NSW
Australian Registration Numbers:
AUST R 147716 (200 mg)
AUST R 148263 (500mg)
In New Zealand:
Merck Sharp & Dohme (New Zealand) Limited
Level 3, 109 Carlton Gore Road
Newmarket
Auckland 1149
® = Registered Trademark
This leaflet was updated July 2011.
