Sugammadex Accord 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sugammadex Accord 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 questions, ask your anaesthetist (anaesthesiologist) or your doctor.
• If you get any side effects, talk to your anaesthetist or another doctor, even if it is not one listed in this leaflet. See section 4.

Contents of this leaflet

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

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

What is Sugammadex Accord

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

What Sugammadex Accord is used for

When undergoing surgery, your muscles must be completely relaxed, which helps the surgeon perform the procedure. For this reason, during general anaesthesia, you will be given medicines to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medicines also block the muscles used for breathing, you will need assistance with breathing (mechanical ventilation) during and after your surgery until you are able to breathe on your own again.

Sugammadex is used to speed up muscle recovery after surgery so that you can breathe independently 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 Accord

Do not receive Sugammadex Accord

• 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 this medicine:

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

Other medicines and Sugammadex Accord

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 Accord

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 Accord may affect hormonal contraceptives

This medicine may make hormonal contraceptives — such as the "Pill", vaginal ring, implants, or a hormonal intrauterine device (IUD-h) — less effective because it reduces the amount of progestogen hormone available. The amount of progestogen lost due to this medicine is approximately the same as when you miss one contraceptive pill.

• If you are taking the Pill on the same day you receive this medicine, 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 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 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 your 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 this medicine, 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 this medicine for the mother.

Driving and using machines

This medicine has no known influence on the ability to drive or operate machinery.

Sugammadex Accord contains sodium

This medicine contains up to 9.7 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 Accord 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 when urgent reversal of neuromuscular blockade is required.

How Sugammadex Accord is administered

This medicine will be given to you by your anaesthetist. It is administered as a single intravenous injection.

If you are given more Sugammadex Accord than you should

Since your anaesthetist will be closely monitoring your condition, it is unlikely that you will receive too much sugammadex. However, even if this were to occur, 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 may cause adverse effects, although not everyone experiences them.

If these adverse effects occur while you are under anesthesia, your anaesthetist 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 gasping for breath
• Light anaesthesia – you may begin to wake up, so you will need more anaesthetic. This may cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing or movement
• Decrease in blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• Breathing difficulty due to muscle spasms in the airways (bronchospasm) occurring in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medicines) – such as rash, skin redness, swelling of the tongue and/or pharynx, difficult breathing, 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

• 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 type of adverse effect, consult your anaesthetist or another doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Accord

Storage should be managed by 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 "EXP". The expiry date refers to the last day of the stated month.

This medicine does not require any special storage temperature. Store the vial in the outer packaging to protect it from light.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sugammadex Accord

• 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 (to adjust pH) and/or sodium hydroxide (to adjust pH).

Appearance of Sugammadex Accord and contents of the pack

Sugammadex Accord is a transparent, colourless to slightly yellow injectable solution, practically free from particles.

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 and Manufacturer

Marketing Authorization Holder

Accord Healthcare, S.L.U

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Synthon Hispania S.L.

Calle De Castello 1

Sant Boi de Llobregat

08830, Barcelona,

Spain

or

Synthon B.V

Microweg 22

Nijmegen

6545 CM, Gelderland

The Netherlands

Member States - Names of the medicinal products

Netherlands: Sugammadex Genthon 100 mg/mL, oplossing voor injectie
Spain: Sugammadex Accord 100 mg/ml solution for injection EFG
Italy: Sugammadex Accord
Portugal: Sugamadex Accord

Date of the most recent revision of this leaflet: January 2026.

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

This information is intended for healthcare professionals only:

For detailed information, consult the Summary of Product Characteristics or the Technical Data Sheet of Sugammadex Accord.