SUGAMMADEX 100 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Sugammadex S.A.L.F. 100 mg/ml Solution for Injection EFG

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your anesthesiologist (anesthetist) or your doctor.
• If you experience side effects, consult your anesthesiologist or another doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sugammadex S.A.L.F. and what is it used for
2. What you need to know before you start taking Sugammadex S.A.L.F.
3. How Sugammadex S.A.L.F. is administered
4. Possible side effects
5. Storage of Sugammadex S.A.L.F.
6. Package Contents and Additional Information

1. What is Sugammadex S.A.L.F. and what is it used for

Sugammadex S.A.L.F. contains the active substance sugammadex. It is considered a Selective Binding Agent because it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex S.A.L.F. is used for

If you need to have surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, you will be given medications during general anesthesia to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medications also block the respiratory muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

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

2. What you need to know before you start taking Sugammadex S.A.L.F.

Do not take Sugammadex S.A.L.F.

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

Tell your anesthesiologist if this applies to you.

Warnings and Precautions

Consult your anesthesiologist before starting Sugammadex S.A.L.F.

• if you have 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 coagulation disorders) or are taking anticoagulant medication.

Children and Adolescents

This medicine is not recommended for children under 2 years of age.

Other Medicines and Sugammadex S.A.L.F.

Tell your anesthesiologist if you are taking, have recently taken, or might take any other medicines.

Sugammadex may affect other medicines or be affected by them.

Some Medicines Reduce the Effect of Sugammadex S.A.L.F.

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

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

Sugammadex S.A.L.F. May Affect Hormonal Contraceptives

Sugammadex may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or a Hormonal Intrauterine Device (IUD) - less effective because it reduces the amount of progestogen that reaches you. The amount of progestogen lost due to the use of Sugammadex is approximately the same as when you miss a birth control pill.

• If you are taking the Pillon the same day that you are given Sugammadex, follow the instructions for missed pills in the package leaflet of your pill.
• If you are using otherhormonal contraceptives (e.g., 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 recommendations in the package leaflet.

Effects on Blood Tests

In general, Sugammadex does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive Sugammadex.

Pregnancy and Breastfeeding

Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding.

Sugammadex may still be given to you, but it is necessary to discuss it first.

It is not known if sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding to the baby and the benefit of treatment to the mother.

Driving and Using Machines

Sugammadex S.A.L.F. has no known influence on the ability to drive and use machines.

Sugammadex S.A.L.F. Contains Sodium

This medicine contains up to 9.2 mg of sodium (a major component of cooking/table salt) in each ml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

3. How Sugammadex S.A.L.F. is Administered

Sugammadex S.A.L.F. will be administered to you by your anesthesiologist or under their supervision.

Dose

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

• your weight
• the amount of muscle relaxant that is still affecting you.

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 from muscle relaxation is needed.

How Sugammadex S.A.L.F. is Administered

Sugammadex will be administered to you by your anesthesiologist. It is injected once via the intravenous route (intravenous use).

If you are given too much Sugammadex S.A.L.F.

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex. But even if this happens, it is unlikely to cause any problems.

If you have any further questions on the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Common Side Effects (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if waking up or taking a breath
• Light anesthesia – you may start to wake up, so you may 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, cough, or movement

• Decrease in blood pressure due to the surgical procedure

Uncommon Side Effects (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 medicines), such as rash, skin redness, swelling of the tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rate, which sometimes result in a severe drop in blood pressure. Allergic reactions or severe allergic reactions can be life-threatening.
• Allergic reactions were reported more frequently in healthy conscious volunteers
• Reappearance of muscle relaxation after surgery

Frequency Not Known

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

Reporting of Side Effects

If you experience side effects, consult your doctor, pharmacist, or nurse. Even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex S.A.L.F.

Storage will be the responsibility of healthcare professionals.

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

Do not use this medicine after the expiry date which is stated on the carton and on the label after “EXP”. The expiry date is the last day of the month stated.

Do not freeze. Store the vial in the outer packaging to protect it from light.

This medicine does not require special temperature storage conditions.

After first opening and dilution, store at 2-8°C and use within 24 hours.

6. Package Contents and Additional Information

Composition of Sugammadex S.A.L.F.

• The active substance is sugammadex.

1 ml of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex.

Each 2 ml ampoule contains sugammadex sodium equivalent to 200 mg of sugammadex. Each 5 ml ampoule contains sugammadex sodium equivalent to 500 mg of sugammadex.

• The other ingredients are water for injections, hydrochloric acid 3.7%.

Appearance and Package Contents

Sugammadex S.A.L.F. is a clear, colorless to slightly yellowish solution for injection.

It comes in two different package sizes, 5 ampoules of 2 ml or 5 ampoules of 5 ml of solution for injection.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

S.A.L.F. S.p.A. Pharmacological Laboratory – Via Marconi, 2 – 24069 Cenate Sotto (BG) – Italy

This medicine is authorized in the Member States of the EEC with the following names:

Date of the Last Revision of this Leaflet: 06/2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics of SUGAMMADEX S.A.L.F..