SUGAMMADEX STADA 100 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Sugammadex Stada 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 any side effects, talk to your anesthesiologist or another doctor, even if it is not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sugammadex Stada and what is it used for
2. What you need to know before you start using Sugammadex Stada
3. How Sugammadex Stada is administered
4. Possible side effects
5. Storage of Sugammadex Stada
6. Contents of the pack and further information

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

What is sugammadex

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Relaxant Binding Agentas it only works with specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What sugammadex is used for

If you have to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this purpose, 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 accelerate muscle recovery after surgery so that you can breathe on your own again sooner. It does this by combining with 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 using Sugammadex Stada

You must notbe given Sugammadex Stada

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

→ Tell your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before you start using Sugammadex Stada.

• 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 before.
• if you have fluid retention (edema).
• if you have a disease that increases the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Children

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

Other medicines and Sugammadex Stada

→ 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

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

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

Sugammadex may affecthormonal contraceptives

• Sugammadex may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD-h) - 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 that lost when you miss a contraceptive pill.

→ If you are taking the Pillon the same day that you are given sugammadex, follow the instructions in case of a missed pill in the pill leaflet.

→ If you are using otherhormonal contraceptives (e.g., 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 leaflet.

Effects on blood tests

In general, sugammadex has no effect on 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.

It may still be given to you, but it needs to be discussed beforehand.

It is not known whether 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 sugammadex to the mother.

Driving and using machines

Sugammadex has no known influence on the ability to drive and use machines.

Sugammadex Stada contains sodium

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

3. How Sugammadex Stada is administered

Sugammadex 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 can be used in adults if urgent recovery of muscle relaxation is needed.

How sugammadex is administered

Sugammadex will be administered to you by your anesthesiologist. It is injected once into a vein.

If you are given too much sugammadex

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, it will be your anesthesiologist who detects and treats them.

Common(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 can 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 surgery

Uncommon(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 your tongue and/or pharynx, difficult 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 any side effects, talk to your anesthesiologist or another doctor, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Stada

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.

This medicine does not require any special storage conditions. Keep the vial in the outer packaging to protect it from light. When not protected from light, the vial should be used within 5 days.

Once opened and diluted, store between 5 °C to 25 °C and use within 48 hours.

From a microbiological point of view, unless the dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Do not use if the solution is not clear and contains visible particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sugammadex Stada

• The active substance is sugammadex.

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

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

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

• The other ingredients are water for injections, hydrochloric acid, and/or sodium hydroxide (for pH adjustment).

Appearance and pack contents

Sugammadex Stada is a clear, colorless to slightly yellowish solution for injection.

It is available in two different pack sizes, containing 10 vials of 2 ml or 10 vials of 5 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814NE Breda,

Netherlands

or

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Sugammadex STADA 100 mg/ml Injektionslösung

Belgium: Sugammadex EG 100 mg/ml oplossing voor injectie

Luxembourg: Sugammadex EG 100 mg/ml, solution injectable

Cyprus: SUGAMMADEX/STADA

Germany: Sugammadex STADA 100 mg/ml Injektionslösung

Denmark: Sugammadex STADA 100 mg/ml injektionsvæske, opløsning

Spain: Sugammadex STADA 100 mg/ml solución inyectable EFG

Greece: SUGAMMADEX/STADA

Finland: Sugammadex STADA 100 mg/ml injektioneste, liuos

France: SUGAMMADEX EG 100 mg/ml, solution injectable

Ireland: Sugammadex Clonmel 100 mg/ml solution for injection

Iceland: Sugammadex STADA 100 mg/ml stungulyf, lausn

Italy: Sugammadex EG

Netherlands: Sugammadex CF 100 mg/ml, oplossing voor injectie

Norway: Sugammadex STADA

Poland: Sugammadex Stada

Portugal: Sugamadex STADA

Sweden: Sugammadex STADA 100 mg/ml injektionsvätska, lösning

Slovenia: Sugamadeks STADA 100 mg/ml raztopina za injiciranje

Date of last revision of this leaflet:December 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/).

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The following information is intended for healthcare professionals only:

For detailed information, refer to the Summary of Product Characteristics or Package Leaflet of Sugammadex Stada 100 mg/ml solution for injection EFG.