Label: Information for the User

Sugammadex Tarbis 100 mg/ml Injectable Solution EFG

Read this label carefully before you receive this medication, as it contains important information for you.

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

What is Sugammadex Tarbis

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

What is Sugammadex Tarbis used for

If you need to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. To achieve this, during general anesthesia, they will administer medications to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. As these medications also block respiratory muscles, you will need assistance with breathing (artificial respiration) during and after your operation until you can breathe on your own again.

Sugammadex is used to accelerate 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 whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (between 2 and 17 years), when rocuronium bromide is used for moderate relaxation.

Do not receive Sugammadex Tarbis

• if you are allergic to sugammadex or any of the other components of this medication (listed in section 6).

→ Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist beforestarting the administration of 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 your 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 (blood clotting disorders) or are taking anticoagulant medication.

Children and adolescents

This medication is not recommended forchildren under 2 years old.

Other medications and Sugammadex Tarbis

→ Inform your anesthesiologist if you are taking, have taken recently, or may need to take any other medication.

Sugammadex may affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Tarbis

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

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

Sugammadex Tarbis may affect hormonal contraceptives

• Sugammadex may make hormonal contraceptives - such as "The Pill", vaginal ring, implants, or an Intrauterine Device (IUD-h) less effective because it reduces the amount of progesterone hormone that reaches you. The amount of progesterone lost due to the use of sugammadex is approximately the same as when you forget a contraceptive pill.

→ If you are takingThe Pillon the same day that sugammadex is administered, follow the instructions in case of missing a pill from the pill package insert.

→ If you are usingotherhormonal contraceptives (for example 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 insert.

Effects on blood tests

In general, sugammadex has no effect on laboratory tests. However, it may affect the results of a blood test when measuring progesterone hormone levels. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive sugammadex.

Pregnancy and breastfeeding

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

It is possible that sugammadex will still be administered, but it is necessary to discuss it.

No information is available on whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid sugammadex treatment, considering the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and operating machines

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

Sugammadex Tarbis contains sodium

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

Sugammadex will be administered by your anesthesiologist, or under the supervision of your anesthesiologist.

Dose

Your anesthesiologist will calculate the dose of sugammadex needed based on:

• your weight
• the amount of muscle relaxant still in effect.

The usual dose is 2-4 mg per kg of body weight for adults and for children and adolescents aged 2-17 years. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Tarbis is Administered

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

If You Are Injected with More Sugammadex Tarbis than Recommended

As your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be administered too much sugammadex. However, even if this happens, it is unlikely to cause any problems.

If you have any other questions about the use of this medication, ask your anesthesiologist or another doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If these adverse effects occur while you are under the effects of anesthesia, it will be your anesthesiologist who will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Cough
• Difficulty with respiratory pathways that may include coughing or movements as if you are awake or taking a breath
• Superficial anesthesia – you may start to wake up, so you will need more anesthetic. 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 surgical intervention

Rare (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle cramps in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medications) – such as rash, skin redness, swelling of your tongue and/or pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes results in a severe decrease in blood pressure. Severe allergic reactions or anaphylaxis can be life-threatening. Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Unknown frequency

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your anesthesiologist or another doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Storage will be handled by healthcare professionals.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the label after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

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

After the first opening and dilution, chemical and physical stability has been demonstrated for use within 24 hours between 2 °C and 25 °C. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, storage times in use and conditions before use are the responsibility of the user.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Composition of Sugammadex Tarbis

The active ingredient is sugammadex.

Each milliliter 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 injectable water, 3.7% hydrochloric acid and/or sodium hydroxide.

Appearance of the product and contents of the packaging

A transparent, colorless to slightly yellowish brown solution.

Package sizes:

1 and 10 vials of 2 mL

1 and 10 vials of 5 mL.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

Pharmadox Healthcare Ltd,

KW20A Kordin Industrial Park,

Paola, PLA 3000,

Malta.

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Sugammadex Amarox 100 mg/ml solution for injection

Germany:Sugammadex Amarox 100 mg/ml Injection solution

Spain: Sugammadex Tarbis 100 mg/ml injectable solution EFG

Last review date of this leaflet: August 2022

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

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This information is intended solely for healthcare professionals:

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