Prospecto: information for the user

Sugammadex Baxter 100 mg/ml injectable solution EFG

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 doubts, 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.

1.What is Sugammadex Baxter and for what it is used

2.What you need to know before starting the administration of Sugammadex Baxter

3.How Sugammadex Baxter is administered

4.Possible adverse effects

5.Storage of Sugammadex Baxter

6.Contents of the package and additional information

What is Sugammadex Baxter

This medicationcontains the active ingredient sugammadex. Sugammadex is considered aselective agglutinant of blockersas it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

How is Sugammadex Baxter used

If you are to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. For this, during general anesthesia, they will give you medications to relax your muscles. They are calledmuscle blockersand some examples are bromide of rocuronium and bromide of vecuronium. As 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 Baxteris 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 17 years), when bromide of rocuronium is used for moderate relaxation.

Do not receive Sugammadex Baxter

• 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 your anesthesiologist before starting the administration of Sugammadex Baxter

• 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

This medication is not recommended for children under 2 years.

Other medications and Sugammadex Baxter

→ Inform your anesthesiologist if you are taking, have taken recently, or may need to take any other medication. Sugammadex Baxtermay affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Baxter

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

• Toremifeno (used to treat breast cancer).
• Fusidic acid (an antibiotic).

Sugammadex Baxter may affect hormonal contraceptives

• Sugammadex Baxtermay make hormonal contraceptives —such as the pill, vaginal ring, implants, or a hormonal intrauterine device (IUD) less effective because it reduces the amount of progesterone that reaches you. The amount of progesterone lost due to the use of Sugammadex Baxteris approximately the same as that lost when you forget to take one of the contraceptive pills.

→ If you are taking thePillon the same day that they administer Sugammadex Baxter,follow the instructions “in case of forgetting to take the tablets” from the pill package insert.

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

Effects on blood tests

In general, Sugammadex Baxterdoes not have effects on laboratory tests. However, it may affect the results of a blood test when measuring progesterone levels. Consult your doctor if yourprogesterone levels need to be analyzed on the same day you receive this medication.

Pregnancy and breastfeeding

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

It may still be administered to you, but it is necessary to discuss it beforehand.

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 benefit of breastfeeding for the baby and the benefit of Sugammadex Baxterfor the mother.

Driving and operating machines

SugammadexBaxterhas no known influence on the ability to drive and operate machines.

Sugammadex Baxter contains sodium

This medication contains up to 9.2 mg of sodium (main component of table salt/for cooking) in eachml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

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

Dose

Your anesthesiologist will calculate the dose of sugammadex 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. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Baxter is administered

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

If you are given more Sugammadex Baxter than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given too much Sugammadex Baxter. 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, it will be your anesthesiologist who will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Coughing.
• Difficulty with respiratory pathways 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 anesthesia. 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.
• Decrease in blood pressure due to surgical intervention.

Rare (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 anaphylaxis can be life-threatening.

Allergic reactions were reported more frequently in healthy, conscious volunteers.

• Reappearance of muscle relaxation after the operation.

Unknown frequency (cannot be estimated from available data)

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

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your anesthesiologist or another doctor, even if it is apossibleadverse effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es ..By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 “EXP”. The expiration date is the last day of the month indicated.

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 Baxter

• The active ingredient is sugammadex.

Each milliliter of injectable solution 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, 3.2% hydrochloric acid (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

Sugammadex Baxter is a transparent, colorless to slightly yellowish-brown injectable solution.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Baxter Holding B.V.

Kobaltweg 49, 3542 CE Utrecht,

Netherlands

Responsible for manufacturing

Solupharm Pharmazeutische Erzeugnisse GmbH,

Industriestrasse 3,

34212 Melsungen,

Germany

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

Baxter S.L.

Pouet de Camilo, 2.

46394 Ribarroja del Turia (Valencia)

This medication is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Irlanda:Sugammadex 100mg/ml Solution for Injection

República Checa:Sugammadex Baxter

Dinamarca:Sugammadex Baxter

Austria:Sugammadex Baxter 100 mg/ml Injektionslösung

Alemania:Sugammadex Baxter 100 mg/ml Injektionslösung

Grecia:Sugammadex/Baxter

España:Sugammadex Baxter 100 mg/ml solución inyectable EFG

Finlandia:Sugammadex Baxter 100 mg/ml injektioneste, liuos

Francia:Sugammadex Baxter 100 mg/ml, solution injectable

Italia:Sugammadex Baxter

Noruega:Sugammadex Baxter

Bélgica:Sugammadex Baxter 100 mg/ml solution injectable

Polonia:Sugammadex Baxter

Portugal:Sugamadex Baxter

Rumanía: Sugammadex Baxter 100 mg/ml solu?ie injectabila

Eslovenia:Sugamadeks Baxter 100 mg/ml raztopina za injiciranje

Suecia:Sugammadex Baxter 100 mg/ml injektionsvätska, lösning

Paises Bajos:Sugammadex Baxter 100 mg/ml oplossing voor injectie

Last review date of this leaflet: June 2023

Other sources of information

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

For detailed information, please consult the Sugammadex Baxter Technical Dossier.