Sugammadex STADA 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sugammadex Stada 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, as you may need to read it again.
• If you have any questions, ask your anaesthetist (anesthesiologist) or your doctor.
• If you experience any side effects, talk to your anaesthetist or another doctor, even if it is a side effect not listed in this leaflet. See section 4.

Package leaflet contents

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

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

Sugammadex Stada is a medicine used to reverse the effects of certain muscle relaxants used during surgery. It specifically reverses the action of neuromuscular blocking agents such as rocuronium and vecuronium, which are used to relax muscles during general anesthesia. By reversing their effects, Sugammadex Stada helps restore normal muscle function after surgery, allowing patients to breathe and move normally again.

What is sugammadex

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

What sugammadex is used for

When you undergo surgery, your muscles need to be completely relaxed, which makes it easier for the surgeon to perform the procedure. For this reason, during general anaesthesia, you will be given medications to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medications also block the muscles involved in breathing, you will need assistance to breathe (mechanical ventilation) during and after surgery until you are able to breathe on your own again.

Sugammadex is used to speed up the recovery of muscle function 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 has been administered, and in children and adolescents (between 2 and 17 years of age) when rocuronium bromide has been used to achieve a moderate level of muscle relaxation.

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

Do not receive Sugammadex Stada

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

→ Inform your anesthetist if this applies to you.

Warnings and precautions

Consult your anaesthetist before starting 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 through the kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (edema).
• if you have any medical condition that increases the risk of bleeding (blood coagulation disorders) or are taking anticoagulant medication.

Children

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Stada

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

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

Some medicines reduce the effect of sugammadex

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

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

Sugammadex 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 decreases the amount of progestogen hormone available. The reduction in progestogen caused by sugammadex is approximately equivalent to 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 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 has no effects 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 tested on the same day you receive sugammadex.

Pregnancy and breastfeeding

→ Inform your anaesthetist if you are pregnant, might 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 operating machinery

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

Sugammadex Stada contains sodium

This medicine contains up to 9.7 mg of sodium (the main component of table/cooking salt) in each ml. This corresponds to 0.5% of the maximum daily recommended intake of sodium for an adult.

3. How Sugammadex Stada is administered

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

Dosage

Your anaesthetist will calculate the dose of sugammad游戏副本ex you need based on:

• your body weight
• the amount of muscle relaxant still having an 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 rapid reversal of muscle relaxation is required.

How sugammadex is administered

Sugammadex will be administered to you by your anesthesiologist. It is injected as a single intravenous dose.

If you are given more sugammadex than recommended

Since your anesthetist will be carefully monitoring your condition, it is unlikely that you will be given too much sugammadex. However, even if this were to happen, it is unlikely to cause any problems.

If you have any further questions about the use of this medicine, ask your anesthetist or another doctor.

4. Possible adverse effects

Like all medicines, this medicine may 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
• respiratory tract difficulties which may include cough or movements as if 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, cough or movement
• decreased blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• difficulty breathing 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, sometimes resulting in a severe drop in blood pressure. Allergic-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 can even lead to cardiac arrest

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your anesthesiologist or another doctor, even if they are possible adverse reactions not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Stada

Storage shall be the responsibility of healthcare professionals.

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product 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 medicinal product 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 within 5 days.

After opening and dilution, store between 5 °C and 25 °C and use within 48 hours.

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

Do not use if the solution is not clear or contains visible particles.

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

6. Contents of the container and additional information

Composition of Sugammadex Stada

• The active substance is sugammadex.

1 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 and/or sodium hydroxide (for pH adjustment).

Appearance of the medicinal product and contents of the container

Sugammadex Stada is a clear, colourless to slightly yellow, injectable solution.

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

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Centrafarm Services B.V.
Van de Reijtstraat 31 E,
4814NE Breda,
The Netherlands

or

STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

or

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

This medicinal product is authorised in the Member States of the European Economic Area under 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

Date of the most recent review of this leaflet: December 2024

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/).

The following information is intended for healthcare professionals only:

For detailed information, please refer to the Summary of Product Characteristics or the Technical Data Sheet of Sugammadex Stada 100 mg/ml solution for injection EFG.