Prospecto: information for the user

Bridion 100mg/ml injectable solution

sugammadex

Read this prospect carefully before this medicine is administered to you,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your anesthesiologist (anesthetist) or doctor.
• If you experience any adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this prospect.See section4.

1.What Bridion is and for what it is used

2.What you need to know before starting Bridion administration

3.How Bridion is administered

4.Possible adverse effects

5.Storage of Bridion

6.Contents of the package and additional information

What is Bridion

Bridion contains the active ingredient sugammadex. Bridion is considered aSelective Muscle Relaxant Agentsince it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

How is Bridion used

If you need to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. To achieve this, during general anesthesia, they will administer medications to relax your muscles. These are calledmuscle relaxants, and examples include bromide of rocuronium and bromide of vecuronium. As these medications also block the muscles of respiration, you will need assistance with breathing (artificial respiration) during and after your operation until you can breathe on your own again.

Bridion is used to accelerate muscle recovery after surgery so that you can breathe on your own again sooner. It does this by combining with bromide of rocuronium or bromide of vecuronium in your body. It can be used in adults as long as bromide of rocuronium or bromide of vecuronium is used and in children and adolescents (between 2 and 17years), when bromide of rocuronium is used for moderate relaxation.

You should not receive Bridion

• if you are allergic to sugammadex or any of the other components of this medication (listed in section6).

→ Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist before startingthe administration of Bridion

• if you have any kidney disease or have had it in the past. This is important because Bridion is eliminated from your body by your kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (edema).
• if you have a disease that increases the risk of bleeding (blood clotting disorders) or are taking anticoagulant medication.

Children and adolescents

This medication is not recommended for children under2years.

Other medications and Bridion

→ Inform your anesthesiologist if you are taking, have taken recently, or may need to take any other medication.

Bridion may affect other medications or be affected by them.

Some medications reduce the effect of Bridion

→It is especially important to inform your anesthesiologist if you have taken recently:

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

Bridion may affect hormonal contraceptives

• Bridion may make hormonal contraceptives‑such as "The Pill", vaginal ring, implants, or a Hormonal Intrauterine Device (IUD‑h) less effective because it reduces the amount of progesterone hormone that reaches you. The amount of progesterone lost due to the use of Bridion is approximately the same as when you forget a contraceptive pill.

→ If you are takingThe Pillon the same day that Bridion is administered, follow the instructions in case of missing a pill from the pill package.

→ If you are usingotherhormonal contraceptives (for example vaginal ring, implant, or IUD‑h), you should use a non-hormonal contraceptive method (such as a condom) for the next 7days and follow the package instructions.

Effects on blood tests

In general, Bridion has no effect on laboratory tests. However, it may affect the results of a blood test when measuring progesterone hormone levels. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive Bridion.

Pregnancy and breastfeeding

→Inform your anesthesiologist if you are pregnant or may be pregnant or if you are breastfeeding.

It is possible that Bridion will still be administered, but it is necessary to discuss it first.

No information is available on whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid sugammadex treatment, considering the benefits of breastfeeding for the baby and the benefits of Bridion for the mother.

Driving and operating machinery

Bridion has no known influence on the ability to drive and operate machinery.

Bridion contains sodium

This medication contains up to 9.7mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

Bridion will be administered by your anesthesiologist, or under the supervision of your anesthesiologist.

Dose

Your anesthesiologist will calculate the dose of Bridion that you need based on:

• Your weight
• The amount of muscle relaxant still in effect.

The usual dose is 2-4 mg per kg of body weight for adults and for children and adolescents between 2-17 years old. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Bridion is Administered

Bridion will be administered by your anesthesiologist. It is given as a single intravenous injection.

If More Bridion is Injected than Recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that too much Bridion will be administered. Even if this happens, it is unlikely to cause any problems.

If you have any other questions about the use of this medication, ask your anesthesiologist or another doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If these side effects occur while you are under the effects of anesthesia, your anesthesiologist will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Coughing
• Respiratory difficulties that may include coughing or movements as if you are awake or taking a breath
• Superficial anesthesia – you may start to wake up, so you will need more anesthetic. This may cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decreased blood pressure due to surgical intervention

Possibly frequent (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle cramps in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medications)‑such as rash, skin redness, swelling of your tongue and/or pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes results in a severe decrease in blood pressure. Severe allergic reactions or anaphylactic reactions can be life-threatening
  Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Unknown frequency

• Slowing of the heart that can even lead to cardiac arrest when Bridion is administered

Reporting of side effects

If you experience any type of side effect, consult your anesthesiologist or another doctor, even if it is a possible side effect not listed in this prospectus. You can also report them directly through theNational Reporting System included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Storage will be handled by healthcare professionals.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the label after “CAD”. The expiration date is the last day of the month indicated.

Store below 30°C. Do not freeze. Store the vial in the outer packaging to protect it from light.

Once opened and diluted, store at 2‑8°C and use within 24 hours.

Composition of Bridion

• The active ingredient issugammadex.

Each milliliter of injectable solution contains sugammadex sodium equivalent to 100mg of sugammadex.

Each vial of 2ml contains sugammadex sodium equivalent to 200mg of sugammadex.

Each vial of 5ml contains sugammadex sodium equivalent to 500mg of sugammadex.

• The other components are water for injection, hydrochloric acid 3.7% and/or sodium hydroxide.

Appearance of the product and contents of the package

Bridion is a transparent, colorless to slightly yellowish injectable solution.

It is presented in two different package sizes, 10vials of 2ml or 10vials of 5ml of injectable solution.

Only some package sizes may be commercially available.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:<{MM/AAAA}><{month YYYY}>.

For detailed information on this medicinal product, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

For detailed information, please refer to the SmPC or the Product Information of BRIDION.