Sugammadex Avalon 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sugammadex Avalon 100 mg/ml solution for injection EFG

Read the entire leaflet carefully before you are given this medicine, because it contains important information for you.

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

Leaflet contents

1. What Sugammadex Avalon is and what it is used for
2. What you need to know before administration of Sugammadex Avalon
3. How Sugammadex Avalon is administered
4. Possible side effects
5. How to store Sugammadex Avalon
6. Contents of the pack and other information

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

What Sugammadex Avalon is

Sugammadex Avalon contains the active substance sugammadex. Sugammadex is considered a Selective Binding Agent because it works only with specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What Sugammadex Avalon is used for

During surgery, your muscles must be completely relaxed, which makes it easier for the surgeon to perform the procedure. For this reason, during general anesthesia you will be given medications to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medications also block the muscles used for breathing, you will need assistance with breathing (mechanical ventilation) 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 works by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used.

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

2. What you need to know before receiving Sugammadex Avalon

Do not receive Sugammadex Avalon

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

→ Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before receiving Sugammadex

• If you have or have previously had any kidney disease. This is important because sugammadex is eliminated from your body through the kidneys.
• If you have or have previously had any liver disease.
• If you have fluid retention (edema).
• If you have a condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Avalon

→ Inform your anaesthetist if you are taking, have recently taken, or might need to take any other medicines.

Sugammadex may affect other medicines or may be affected by them.

Some medicines reduce the effect of Sugammadex Avalon

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

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

Sugammadex Avalon may affect hormonal contraceptives

• Sugammadex may reduce the effectiveness of hormonal contraceptives—such as the "Pill", vaginal ring, implants, or hormonal intrauterine device (IUD-h)—because it reduces the amount of progestogen hormone available to you. The amount of progestogen lost due to Sugammadex use is approximately equivalent to missing one contraceptive pill.

→ If you take the Pill on the same day that Sugammadex is administered, follow the missed dose instructions provided in the Pill’s package leaflet.

→ If you are using other hormonal contraceptives (e.g., vaginal ring, implant, or IUD-h), you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the product leaflet.

Effects on blood tests

In general, Sugammadex does not have any effects on laboratory tests. However, it may affect the results of a blood test measuring levels of the hormone progesterone. Consult your doctor if progesterone levels need to be tested on the same day you receive this medicine.

Pregnancy and breastfeeding

→ Inform your anaesthetist if you are pregnant, may be pregnant, or are breastfeeding.

You may still be given Sugammadex, but this should be discussed beforehand.

It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to interrupt breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the baby and the benefits of Sugammadex for the mother.

Driving and using machines

Sugammadex Avalon has no known influence on the ability to drive or operate machinery.

Sugammadex Avalon contains sodium

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

3. How Sugammadex Avalon is administered

Sugammadex will be administered to you by your anaesthetist, or under the supervision of your anaesthetist.

Dosage

Your anaesthetist will calculate the dose of sugammadex you need based on:

• Your body weight
• The amount of residual muscle relaxant effect still present.

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 rapid reversal of muscle relaxation is required.

How Sugammadex Avalon is administered

Sugammadex will be administered by your anaesthetist. It is given as a single intravenous injection.

If you are given more Sugammadex Avalon than you should

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will receive too much sugammadex. However, 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 anaesthetist or another doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Frequent (may affect up to 1 in 10 people)

• Cough
• Airway difficulties which may include coughing or movements as if awake or taking a deep breath
• Superficial anesthesia – you may begin to wake up, so you will need more anesthetic. This may cause you to move or cough at the end of surgery
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decreased blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• Breathing difficulty due to muscle cramps in the airways (bronchospasm), occurring in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medicines) – such as rash, redness of the skin, swelling of the tongue and/or pharynx, shortness of breath, changes in blood pressure or heart rhythm, which sometimes result in a severe drop in blood pressure. Allergy-type reactions or severe allergic reactions may be life-threatening

Allergic reactions were reported more frequently in healthy conscious volunteers

• Recurrence of muscle relaxation after surgery

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any kind of adverse effect, consult your anesthetist or another physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Avalon

Storage is 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 stated on the carton and label after "CAD". The expiry date refers to the last day of the month indicated.

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 other information

Composition of Sugammadex Avalon

• The active substance is sugammadex.

Each ml of injectable solution contains sodium sugammadex equivalent to 100 mg of sugammadex.

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

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

• The other components are water for injections, hydrochloric acid 3.2% (to adjust pH) and/or sodium hydroxide (to adjust pH).

Appearance of the product and contents of the container

Sugammadex Avalon is a clear, colourless to slightly yellowish injectable solution.

It is available in two different pack sizes: 10 vials of 2 ml or 10 vials of 5 ml of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Avalon Laboratorios, S.L.,
C/ La Cora, número 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 medicinal product 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 the most recent review of this leaflet: March 2025

Other sources of information

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