Bridion 100 mg/ml solution for injection

Bridion is one of a group of medicines calledSelective Relaxant Binding Agents. It is used to speed up the recovery of your muscles after an operation.
When you have some types of operation, 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 stop muscle relaxants working. It does this by combining with the rocuronium bromide or vecuronium bromide 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 should not be given Bridion

• if you are allergic ( hypersensitive) tosugammadex or any of the other ingredients. ? Tell your anaesthetist if this applies to you.

Take special care with Bridion

• if you have kidney disease or had in the past. This is important as Bridion is removed from your body by the kidneys.
• if you have heart disease or have had it in the past.
• if you have liver disease or have had it in the past.
• if you have fluid retention (oedema).
• if you are on a controlled salt diet.
• if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medication. ? Tell your anaesthetist if any of the above applies to you.

Taking other medicines

? Please tell your anaesthetist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal products.
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:

• toremifene (used to treat breast cancer).
• fusidic acid (an antibiotic).

Bridion can affect hormonal contraceptives

• Bridion can make hormonal contraceptives - including the ?Pill?, vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone. The amount of progestogen lost by using Bridion is about the same as missing one oral contraceptive Pill. ? If you are taking the Pill on the same day as Bridion is given to you, follow the instructions for a missed dose in the Pill?s package leaflet. ? If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.

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.

Pregnancy and breast-feeding
? Tell your anaesthetist if you are pregnant or might be pregnant.
You may still be given Bridion, but you need to discuss it first.
Sugammadex can be used during breast-feeding.

Driving and using machines

Your doctor will tell you when it is safe to drive or operate machinery after you have been given Bridion. Bridion is not known to have an effect on alertness or concentration.

The dose

Your anaesthetist will work out the dose of Bridion you need based on:

• your weight
• how much the muscle relaxant medicine is still affecting you. The usual dose is 2-4 mg per kg body weight. A higher dose may be given if the anaesthetist wants you to recover faster.

The dose of Bridion for children is 2 mg/kg (children and adolescents between 2-17 years old).

How Bridion is given

Bridion will be given to you by your anaesthetist. It is given into a vein (intravenously) as a single injection.

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 medicinal product, ask your doctor or pharmacist.

Like all medicines, Bridion can cause side effects, although not everybody gets them. If these side effects occur while you are under anaesthesic, they will be seen and treated by your anaesthetist.

Very common side effects (in more than 1 user in 10)

• A temporary unpleasant taste in your mouth.

Common side effects (in 1 to 10 users in 100)

• Light anaesthesia - you may start to come out of deep sleep, so need more anaesthesia. This might cause you to move or cough at the end of the operation.
• Your muscles may turn weak again after the operation (if a too low dose is administered).

Uncommon side effects (in 1 to 10 users in 1,000)

• Being awake during the operation (anaesthesia awareness)
• Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of asthma
• Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Bridion after the expiry date which is stated on the vial and the carton.

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.

What Bridion contains

• The active substance is sugammadex. 1 ml solution for injection contains 100 mg sugammadex (as sodium salt)
• The other ingredients are water for injections, hydrochloric acid 3.7% and/or sodium hydroxide (to adjust pH).

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
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

Manufacturers

• N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
• Organon (Ireland) Ltd., Drynam Road, Swords, Co. Dublin, Ireland

This leaflet was last approved in {MM/YYYY}

--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only: For detailed information refer to the Summary of Product Characteristics of BRIDION.