SUGAMMADEX KALCEKS 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Kalceks 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 doctor.
• If you get any side effects, talk to your anesthesiologist or doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

What is Sugammadex Kalceks

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

What Sugammadex Kalceks is used for

When you undergo certain types of operations, your muscles must be completely relaxed. This makes the operation easier for the surgeon. To achieve this, the general anesthesia you are given includes medications that relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medications also relax the respiratory muscles, you will need help breathing (artificial ventilation) during and after the operation until you can breathe on your own again.

This medicine is used to speed up the recovery of your muscles after an operation and allow you to breathe on your own sooner. It does this by binding to the rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used.

It can also be used in newborns, infants, children, and adolescents (from birth to 17 years) when rocuronium bromide is used.

2. What you need to know before you are given Sugammadex Kalceks

Do not receive Sugammadex Kalceks

• 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

Consult your anesthesiologist before you are given Sugammadex Kalceks

• if you have or have had kidney disease. This is important because sugammadex is removed from your body by your kidneys.
• if you have or have had liver disease.
• if you have fluid retention (edema).
• if you have a condition that increases the risk of bleeding or if you are taking anticoagulant medication.

Other medicines and Sugammadex Kalceks

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 to tell your anesthesiologist if you have recently taken:

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

Sugammadex may affect hormonal contraceptives

This medicine may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal 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 contraceptive 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

Generally, this medicine 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. You may still be given sugammadex, but this needs to be discussed beforehand.

It is not known if sugammadex passes into breast milk. Your anesthesiologist will help you decide whether to stop 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

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

Sugammadex Kalceks contains sodium

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

3. How Sugammadex Kalceks is given

This medicine will be given 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 patients of any age. A dose of 16 mg/kg may be used in adults if urgent recovery from muscle relaxation is needed.

How Sugammadex Kalceks is given

This medicine will be given to you by your anesthesiologist. It is injected once into a vein.

If you are given more Sugammadex Kalceks than recommended

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 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 (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 the surgical procedure

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 can be life-threatening. Allergic reactions were reported more frequently in healthy, conscious volunteers.
• Reappearance of muscle relaxation after the operation

Frequency not known(cannot be estimated from the available data)

• 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 doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Kalceks

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 of the vial after "EXP". The expiry date is the last day of the month stated.

Do not store above 30°C.

Keep the vials in the outer packaging to protect them from light.

After opening the vial and dilution, the chemical and physical stability has been demonstrated for 48 hours at 25°C and 2-8°C.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature of 2-8°C, unless the dilution has been made in controlled and validated aseptic conditions.

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 Kalceks

• The active substance is sugammadex.

1 ml 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 (excipients) are sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

Appearance and packaging of the product

Sugammadex Kalceks is a clear, colorless to slightly yellow solution, available in glass vials of 2 ml or 5 ml of injectable solution. Each carton contains 1 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057, Latvia

Phone: +371 67083320

Email: [email protected]

For further information about this medicine, contact the local representative of the marketing authorization holder

Grindeks Kalceks España, S.L.

c/ José Abascal, 58 2º dcha

28003 Madrid

Spain

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

Denmark Sugammadex Kalceks

Austria, Germany Sugammadex Kalceks 100 mg/ml Injektionslösung

Czech Republic, Estonia, Finland, Italy, Norway, Poland, Sweden Sugammadex Kalceks

Belgium Sugammadex Kalceks 100 mg/ml oplossing voor injectie

Sugammadex Kalceks 100 mg/ml solution injectable

Sugammadex Kalceks 100 mg/ml Injektionslösung

Croatia Sugamadeks Kalceks 100 mg/ml otopina za injekciju

France SUGAMMADEX KALCEKS 100 mg/mL, solution injectable

Hungary Sugammadex Kalceks 100 mg/ml oldatos injekció

Ireland Sugammadex 100 mg/ml solution for injection

Latvia Sugammadex Kalceks 100 mg/ml šķīdums injekcijām

Lithuania Sugammadex Kalceks 100 mg/ml injekcinis tirpalas

Netherlands Sugammadex Kalceks 100 mg/ml oplossing voor injectie

Portugal Sugamadex Kalceks

Romania Sugammadex Kalceks 100 mg/ml solutie injectabila

Slovenia Sugamadeks Kalceks 100 mg/ml raztopina za injiciranje

Slovakia Sugammadex Kalceks 100 mg/ml injekčný roztok

Spain Sugammadex Kalceks 100 mg/ml solución inyectable EFG

Date of last revision of this leaflet:July 2025

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

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This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics or Package Leaflet of Sugammadex Kalceks.