SUGAMMADEX AVALON 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

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

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

What is Sugammadex Avalon

Sugammadex Avalon 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 Avalon is used for

If you are going to have surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, during general anesthesia, you will be given medications 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 speed up 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.

It can 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 start using Sugammadex Avalon

Do not use Sugammadex Avalon

• 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 starting treatment with Sugammadex

• 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 (coagulation disorders) or are taking anticoagulant medication.

Other medicines and Sugammadex Avalon

→ 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 Avalon

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

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

Sugammadex Avalon 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 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 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 this medicine.

Pregnancy and breastfeeding

→ Tell your anesthesiologist if you are pregnant or might be pregnant or if you are breastfeeding.

It is possible that you will still be given Sugammadex, but it needs to be discussed beforehand.

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

Driving and using machines

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

Sugammadex Avalon 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.

3. How Sugammadex Avalon 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 patients of any age. A dose of 16 mg/kg can be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Avalon is administered

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

If you are given more Sugammadex Avalon than recommended

Since your anesthesiologist will be carefully controlling 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 about 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.

Frequent (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if waking up or taking deep breaths
• 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 intervention

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, shortness of breath, 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 (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, consult your anesthesiologist or another doctor, even if they are 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 Avalon

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.

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

6. Contents of the pack and further information

Composition of Sugammadex Avalon

• 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 3.2% (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

Appearance and packaging of the product

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

It comes 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

Avalon Laboratorios, S.L.,

C/ La Cora, number 4, Local 1,

18006 Granada (Granada) Spain

Manufacturer

Solupharm Pharmazeutische Erzeugnisse Gmbh

Industriestrasse 3

34212 Melsungen

Germany

Inresa Arzneimittel GmbH,

Obere Hardtraße 18,

79114 Freiburg,

Germany

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

Germany: Sugammadex Inresa 100 mg/ml Injektionslösung

Spain: Sugammadex Avalon 100 mg/ml solution for injection EFG

Ireland: Sugammadex 100 mg/ml solution for injection

Date of last revision of this leaflet:March 2025

Other sources of information

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