Sugammadex Stada

Leaflet attached to the packaging: information for the user

Sugammadex Stada, 100 mg/ml, solution for injection

sugammadex

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your anesthesiologist or another doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your anesthesiologist or another doctor. See section 4.

Table of contents of the leaflet

• 1. What is Sugammadex Stada and what is it used for
• 2. Important information before taking Sugammadex Stada
• 3. How is Sugammadex Stada administered
• 4. Possible side effects
• 5. How to store Sugammadex Stada
• 6. Package contents and other information

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

What is Sugammadex Stada

Sugammadex Stada contains the active substance sugammadex. Sugammadex Stada is considered a selective relaxant binding agentbecause it only acts with certain muscle relaxants - rocuronium bromide or vecuronium bromide.

What is Sugammadex Stada used for

In case of the need to perform certain types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the operation more easily. To do this, muscle relaxants are administered during general anesthesia. These are referred to as muscle relaxantsand include rocuronium bromide and vecuronium bromide. Since these drugs also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during and after surgery until the patient's own breathing returns. Sugammadex Stada is used to accelerate the return of muscles to their normal state after surgery, so that the patient can breathe on their own as soon as possible. Its action is based on binding to rocuronium bromide or vecuronium bromide in the body. The drug can be used in adults when rocuronium bromide or vecuronium bromide has been administered, as well as in children and adolescents (aged 2 to 17) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before taking Sugammadex Stada

When not to take Sugammadex Stada:

Warnings and precautions

Before taking Sugammadex Stada, discuss it with your anesthesiologist:

Children and adolescents

The use of this medicine is not recommended in children under 2 years of age.

Sugammadex Stada and other medicines

Tell your anesthesiologist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Sugammadex Stada may affect the action of other medicines or other medicines may affect the action of Sugammadex Stada.

Some medicines reduce the effectiveness of Sugammadex Stada

It is especially important to inform your anesthesiologist if the patient has taken the following medicines recently:

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

Sugammadex Stada may affect the effectiveness of hormonal contraceptives

• Sugammadex Stada may reduce the effectiveness of hormonal contraceptives, including the "pill", vaginal ring, implant, or intrauterine system releasing progestogen (hormonal intrauterine device), as it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex Stada is roughly equivalent to missing one contraceptive pill. If the "pill" is taken on the same day that Sugammadex Stada is administered, follow the instructions for missing a pill in the hormonal contraceptive leaflet. If other hormonal contraceptives (such as a vaginal ring, implant, or hormonal intrauterine device) are used, use an additional non-hormonal contraceptive method (e.g., condoms) for the next 7 days and follow the recommendations in the leaflet for the specific contraceptive.

Effect on blood test results

Normally, Sugammadex Stada does not affect laboratory test results. However, it may affect the results of blood tests for the hormone progesterone. Consult your doctor if the progesterone level in the blood should be tested on the same day that Sugammadex Stada is administered.

Pregnancy and breastfeeding

Tell your anesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding. The patient can still be given Sugammadex Stada, but this should be discussed with the doctor. It is not known whether sugammadex passes into breast milk. The anesthesiologist will help the patient decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Stada for the mother.

Driving and using machines

Sugammadex Stada has no known effect on the ability to drive or use machines.

Sugammadex Stada contains sodium

This medicine contains up to 9.7 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How is Sugammadex Stada administered

Sugammadex Stada will be administered to the patient by an anesthesiologist or under the supervision of an anesthesiologist.

Dose

The anesthesiologist will adjust the dose of Sugammadex Stada based on:

• the patient's body weight,
• the dose of muscle relaxant used. The usual dose is 2 to 4 mg/kg body weight in adults and children and adolescents aged 2-17. If rapid recovery of muscle tension is necessary, a dose of 16 mg/kg body weight can be used in adults.

How is Sugammadex Stada administered

Sugammadex Stada is administered by an anesthesiologist. It is given as a single injection through an intravenous line.

If more Sugammadex Stada is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Stada will occur. Nevertheless, in the event of such an occurrence, no problems should arise. If you have any further questions about the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur during anesthesia, they will be noticed and treated by the anesthesiologist. Frequent side effects(may occur in up to 1 in 10 people)

• cough
• breathing difficulties, including cough or movement, such as when waking up or taking a breath
• mild anesthesia - the patient may start to wake up from deep sleep and need more anesthetic. This can cause movement or cough at the end of the operation
• complications during the procedure, such as changes in heart rate, cough, or movement
• decreased blood pressure related to the surgical procedure

Uncommon side effects(may occur in up to 1 in 100 people)

• shortness of breath due to bronchospasm in patients with a history of lung disease
• allergic reactions (hypersensitivity to the medicine) - such as rash, skin redness, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in severe low blood pressure. Severe allergic reactions or anaphylaxis can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers.
• return of muscle relaxation after surgery

Frequency not known(frequency cannot be estimated from the available data)

• after administration of Sugammadex Stada, severe cases of bradycardia, as well as bradycardia, up to cardiac arrest, are possible

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your anesthesiologist or another doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Stada

The medicine will be stored by healthcare professionals. The medicine should be stored out of 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. This medicine does not require special temperature storage conditions. Store the vials in the outer packaging to protect from light. If there is no protection from light, the vials should be used within 5 days. After first opening and dilution, store at a temperature between 5°C and 25°C and use within 48 hours. Considering microbiological aspects, the diluted product should be used immediately, unless the dilution method precludes the risk of microbiological contamination. In the case of not using the product immediately, the user is responsible for the storage time and conditions. Do not use solutions that are not clear and contain visible particles. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sugammadex Stada contains

• The active substance is sugammadex. 1 ml contains 100 mg of sugammadex as sugammadex sodium. Each 2 ml vial contains 200 mg of sugammadex as sugammadex sodium. Each 5 ml vial contains 500 mg of sugammadex as sugammadex sodium.
• The other ingredients are: water for injections, hydrochloric acid, and/or sodium hydroxide.

What Sugammadex Stada looks like and what the package contains

Sugammadex Stada is a clear solution for injection, colorless to slightly yellow. It is available in two different package sizes, each containing 10 vials of 2 ml or 5 ml of solution for injection. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany. Manufacturer/Importer: Centrafarm Services B.V., Van De Reijtstraat 31 E, 4814 NE Breda, Netherlands. Clonmel Healthcare Ltd., Waterford Road, E91 D768 Clonmel, Ireland. STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria. For more detailed information, please contact the representative of the marketing authorization holder: Stada Pharm Sp. z o.o., ul. Krakowiaków 44, 02-255 Warsaw, Tel. +48 22 737 79 20

This medicine is registered in the Member States of the European Union under the following names:

Austria, Sugammadex STADA 100 mg/ml Injektionslösung, Belgium, Sugammadex EG 100mg/ml oplossing voor injectie, Luxembourg, Sugammadex EG 100mg/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, Poland, Sugammadex Stada, Norway, Sugammadex STADA, Portugal, Sugamadex STADA, Sweden, Sugammadex STADA 100 mg/ml injektionsvätska, lösning, Slovenia, Sugamadeks STADA 100 mg/ml raztopina za injiciranje

Date of last revision of the leaflet: -----------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

To obtain detailed information, refer to the Summary of Product Characteristics of Sugammadex Stada