Sugammadex Tarbis 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sugammadex Tarbis 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 experience any side effects, talk to your anaesthetist or another doctor, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

What Sugammadex Tarbis is

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

What Sugammadex Tarbis is used for

When undergoing surgery, your muscles need to be completely relaxed, which makes the surgical procedure easier for the surgeon. For this reason, during general anaesthesia, you will be given medications to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these drugs also block the muscles involved in 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 accelerate muscle recovery after surgery, allowing you to 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 Tarbis

Do not receive Sugammadex Tarbis

• 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 via the kidneys.
• you have or have previously had any liver disease.
• you have fluid retention (edema).
• you have a condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Tarbis

→ 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 Tarbis

→ 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 Tarbis may affect hormonal contraceptives

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

→ If you are taking the Pill on the same day sugammadex is administered, follow the missed tablet instructions provided in the contraceptive 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 contraceptive’s package leaflet.

Effects on blood tests

In general, sugammadex has no effect 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 sugammadex.

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

Sugammadex Tarbis contains sodium

This medicine contains up to 9.17 mg of sodium (the main component of table/cooking salt) per ml. This is equivalent to 0.47% of the maximum daily recommended intake of sodium for an adult.

3. How Sugammadex Tarbis 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 to 4 mg per kg of body weight for patients of any age. In adults, a dose of 16 mg/kg may be given if rapid reversal of muscle relaxation is required.

How Sugammadex Tarbis is administered

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

If more Sugammadex Tarbis is administered than recommended

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will receive too much sugammadex. However, even if this occurs, 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 the effects of anaesthesia, they will be detected and treated by your anaesthetist.

Frequent (may affect up to 1 in 10 people)

• Cough
• Respiratory tract difficulties which may include coughing or movements as if awake or gasping for breath
• Superficial anaesthesia – you may begin to wake up, so you will require 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 procedure

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, skin redness, swelling of the tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rhythm, which sometimes result in a severe drop in blood pressure. Allergy-like reactions or severe allergic reactions may be life-threatening. Allergic reactions have been 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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Tarbis

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 "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature conditions.

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

After first opening and dilution, chemical and physical in-use stability has been demonstrated for 24 hours between 2 °C and 25 °C. From a microbiological standpoint, 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.

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

6. Contents of the pack and other information

Composition of Sugammadex Tarbis

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 3.7% and/or sodium hydroxide.

Appearance of the product and contents of the container

A clear, colourless to slightly yellowish brown solution.

Pack sizes:

1 and 10 vials of 2 mL

1 and 10 vials of 5 mL.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

The Netherlands

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta.

This medicinal product is authorised in the European Economic Area member states under the following names:

Netherlands: Sugammadex Amarox 100 mg/ml oplossing voor injectie

Germany: Sugammadex Amarox 100 mg/ml Injektionslösung

Spain: Sugammadex Tarbis 100 mg/ml solución inyectable EFG

Date of the most recent review of this leaflet: December 2025

Detailed information on this medicinal product 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 Tarbis.