SUGAMMADEX GALENICUM 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

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

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

What is Sugammadex Galenicum

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

What Sugammadex Galenicum is used for

If you need to undergo 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, such as 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 the recovery of your muscles 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 Galenicum

Do not use Sugammadex Galenicum

• 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

Talk to your anesthesiologist before starting Sugammadex Galenicum:

• if you have or have had kidney disease. This is important because sugammadex is eliminated from your body by the kidneys.
• if you have or have had liver disease.
• 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 Galenicum

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 Galenicum

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

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

Sugammadex Galenicum may affect hormonal 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 when you miss a contraceptive pill.

• If you are taking the Pill on the same day that you are given sugammadex, follow the instructions in case of a missed pill in the package leaflet of the Pill.
• 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 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.

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

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

Driving and using machines

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

Sugammadex Galenicum contains sodium

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

Tell your anesthesiologist if you are on a controlled salt diet.

3. How Sugammadex Galenicum is administered

Sugammadex will be administered 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. A dose of 16 mg/kg may be used in adults if urgent recovery from muscle relaxation is needed.

The dose of sugammadex for children is 2 mg/kg (children and adolescents between 2 and 17 years).

How Sugammadex Galenicum is administered

Sugammadex will be administered by your anesthesiologist. It is given as a single injection into a vein.

If you are given too much Sugammadex Galenicum

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 (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if you were awake 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 can 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 (cannot be estimated from the available data)

• When sugammadex is administered, it can cause a significant slowing of the heart, 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 a possible side effect not listed in this leaflet. You can also report side effects 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 Galenicum

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 shown.

Store the vial in the outer packaging to protect it from light.

After opening and dilution, store between 2 and 8 °C and use within 24 hours.

6. Contents of the pack and further information

Composition of Sugammadex Galenicum

• The active substance is sugammadex.

Each 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 packaging of the product

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

It is presented as a clinical pack, in two different pack sizes, 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

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat 08950 Barcelona

Spain

Manufacturer

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat 08950 Barcelona

Spain

or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

San Agustín de Guadalix, 28750, Madrid

Spain

Date of last revision of this leaflet: June 2024

Other sources of information

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