Prospect: information for the user

Sugammadex Fresenius Kabi 100 mg/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 section 4.

What is Sugammadex Fresenius Kabi

Sugammadex Fresenius Kabi contains the active ingredient sugammadex. Sugammadex is considered a selective binding agentsince it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

What is Sugammadex Fresenius Kabi used for

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

Sugammadex is used to speed up the recovery of your muscles after an operation 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 17 years), when bromide of rocuronium is used for a moderate level of relaxation.

Do not receive Sugammadex Fresenius Kabi

• if you are allergic to sugammadex or any of the other components of this medication (listed in section 6).

Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult with your anesthesiologist before starting the administration of sugammadex

• if you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body by the 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 under 2 years old.

Other medications and Sugammadex Fresenius Kabi

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

Sugammadex may affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Fresenius Kabi

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

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

Sugammadex Fresenius Kabi may affect hormonal contraceptives

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

→If you are takingThe Pillon the same day that sugammadex 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 7 days and follow the recommendations in the package insert.

Effects on blood tests

In general, sugammadex 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 sugammadex.

Pregnancy and breastfeeding

Inform your anesthesiologist if you are pregnant or may be pregnant or if you are breastfeeding. It is possible that sugammadex will still be administered, but it needs to be discussed 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 treatment with sugammadex, considering the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and operating machines

Sugammadex Fresenius Kabi has no known influence on the ability to drive and operate machines.

Sugammadex Fresenius Kabi contains sodium

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

Sugammadex Fresenius Kabi will be administered by your anesthesiologist, or under the supervision of your anesthesiologist.

Dose

Your anesthesiologist will calculate the dose of sugammadex needed 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 Sugammadex Fresenius Kabi is Administered

Sugammadex will be administered by your anesthesiologist. It is injected once via intravenous route.

If more Sugammadex Fresenius Kabi is Injected than Recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that too much sugammadex 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 medications, this medication may produce adverse effects, although not all people will experience them.

If these adverse 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 procedure
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decreased blood pressure due to surgical intervention

Rare (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle spasms in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to the active ingredient) – 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 severe blood pressure decrease. Severe allergic reactions or anaphylaxis can be life-threatening
• Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Unknown frequency

• When sugammadex is administered, a significant slowing of the heart may occur, which can even lead to cardiac arrest

Reporting Adverse Effects

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

Storage will be the responsibility of 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.

This medication does not require any special storage temperature. 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 Sugammadex Fresenius Kabi

• The active ingredient is sugammadex.

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

Each vial of 1 ml contains sodium sugammadex equivalent to 100 mg of sugammadex.

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

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

• The other components are injectable water, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment). See section 2 “Sugammadex Fresenius Kabi contains sodium”.

Appearance of the product and contents of the packaging

Sugammadex Fresenius Kabi is a transparent, colorless to slightly yellowish, particle-free injectable solution. It is presented in three different packaging sizes containing 10 vials of 1 ml, 2 ml, or 5 ml of injectable solution.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1,

61352 Bad Homburg v.d.Höhe

Germany

Responsible for Manufacturing

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

For more information about this medication, please contact the local representative of the marketing authorization holder.

Last review date of this leaflet

The detailed information about this medication is available on the European Medicines Agency website:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

For detailed information, please consult the Technical Dossier or the Summary of Product Characteristics of Sugammadex Fresenius Kabi.