Introduction

Label: information for the user

Sugammadex Stada 100 mg/ml injectable solution EFG

Read this label carefully before this medicine is administered to you, 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 (anesthetist) 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.

Label content

What Sugammadex Stada is and for what it is used
What you need to know before starting administration of Sugammadex Stada
How to administer Sugammadex Stada
Possible adverse effects
Storage of Sugammadex Stada
Contents of the package and additional information

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

What is sugammadex

This medication contains the active ingredient sugammadex. Sugammadex is considered aSelective Agent of Blocker Bindingsince it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

For what sugammadex is used

If you have to operate, your muscles must be completely relaxed, which facilitates the surgeon's operation. For this, during general anesthesia, they will give you medications so that your muscles relax. They are calledmuscle blockers, and for example, they are bromide of rocuronium and bromide of vecuronium. As those medications also block the muscles of breathing, you will need help to breathe (artificial respiration) during and after your operation until you can breathe again on your own.

Sugammadex is used to accelerate the recovery of muscles after an operation so that you can breathe on your own again sooner. It does this by combining with bromide of rocuronium or bromide of vecuronium in your body. It can be used in adults as long as bromide of rocuronium or bromide of vecuronium is used and in children and adolescents (between 2 and 17 years), when bromide of rocuronium is used for a moderate level of relaxation.

2. What you need to know before starting the administration of Sugammadex Stada

You should not receive Sugammadex Stadaif you are allergic to sugammadex or any of the other ingredients of this medication (listed in section 6).

Inform your anesthesiologist if this is the case.

→ Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist beforestarting the administration of Sugammadex Stada.

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

This medication is not recommended for children under 2 years.

Other medications and Sugammadex Stada

→ 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

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

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

Sugammadex may affecthormonal contraceptives

Sugammadex may make hormonal contraceptives - such as "The Pill", vaginal ring, implants, or an Intrauterine Device Hormonal (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 forgetting 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 you may still receive sugammadex, but it is necessary to discuss it beforehand.

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

Driving and operating machinery

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

Sugammadex Stada contains sodium

This medication contains up to 9.7 mg of sodium (main component of table salt/for cooking) per ml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

3. How Sugammadex Stada is Administered

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

Dose

Your anesthesiologist will calculate the dose of sugammadex you need 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 between 2-17 years old. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How sugammadex is administered

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

If you are given more sugammadex than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given too much sugammadex. 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.

4. Possible Adverse Effects

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, your anesthesiologist will detect and treat them.

Frequent(may affect up to 1 in 10 people)

Coughing
Respiratory difficulties 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
Decreased blood pressure due to surgical intervention

Infrequent(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 throat, difficult breathing, changes in blood pressure or heart rate, which sometimes results in severe blood pressure drop. 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Storage of Sugammadex Stada

Storage will be the responsibility of 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. When not protected from light, the vial must be used before 5 days.

Once opened and diluted, store between5 °C to 25 °C and use before 48 hours.

From a microbiological point of view, unless the dilution method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately,storage times in use and conditions are the responsibility of the user.

Do not use if the solution is not transparent and contains visible particles.

Medications should not be disposed of through drains or in the trash. Ask your pharmacisthow to dispose ofthe packaging and themedications that you no longerneed.This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Sugammadex Stada

The active ingredient is sugammadex.

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

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

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

The other components are injectable preparation water, hydrochloric acid and/or sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the package

Sugammadex Stada is a transparent, colorless to slightly yellowish injectable solution.

It is presented in two different package sizes, containing 10 vials of 2 ml or 10 vials of 5 ml of injectable solution.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814NE Breda,

Netherlands

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Vienna

Austria

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

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

Austria: Sugammadex STADA 100 mg/ml Injektionslösung

Belgium: Sugammadex EG 100 mg/ml oplossing voor injectie

Luxembourg: Sugammadex EG 100 mg/ml, solution injectable

Cyprus: SUGAMMADEX/STADA

Germany: Sugammadex STADA 100 mg/ml Injektionslösung

Denmark: Sugammadex STADA 100 mg/ml injektionsvæske, opløsning

Spain: Sugammadex STADA 100 mg/ml solución inyectable EFG

Greece: SUGAMMADEX/STADA

Finland: Sugammadex STADA 100 mg/ml injektioneste, liuos

France: SUGAMMADEX EG 100 mg/ml, solution injectable

Ireland: Sugammadex Clonmel 100 mg/ml solution for injection

Iceland: Sugammadex STADA 100 mg/ml stungulyf, lausn

Italy: Sugammadex EG

Netherlands: Sugammadex CF 100 mg/ml, oplossing voor injectie

Norway: Sugammadex STADA

Poland: Sugammadex Stada

Portugal: Sugamadex STADA

Sweden: Sugammadex STADA 100 mg/ml injektionsvätska, lösning

Slovenia: Sugamadeks STADA 100 mg/ml raztopina za injiciranje

Last review date of this leaflet: December 2024

The detailed 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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The following information is intended only for healthcare professionals:

For detailed information, please consult the Technical Dossier or Summary of Characteristics of Sugammadex Stada 100 mg/ml injectable solution EFG.

Sugammadex stada 100 mg/ml solucion inyectable efg