Sugammadex Zentiva

Package Leaflet: Information for the Patient

Sugammadex Zentiva, 100 mg/mL, Solution for Injection

Sugammadex

Read the package leaflet carefully before the medicine is given, 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 you experience any side effects, including those not listed in this leaflet, tell your anesthesiologist or another doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Sugammadex Zentiva and what is it used for
• 2. Important information before using Sugammadex Zentiva
• 3. How Sugammadex Zentiva is given
• 4. Possible side effects
• 5. How to store Sugammadex Zentiva
• 6. Contents of the pack and other information

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

What is Sugammadex Zentiva

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

What is Sugammadex Zentiva used for

In some types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the operation more easily. To achieve this, muscle relaxants are given during general anesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Since these medicines 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 Zentiva is used to speed up the recovery of muscle function after surgery, so that the patient can breathe on their own again sooner. Its action involves binding to rocuronium bromide or vecuronium bromide in the body. The medicine can be used in adults when rocuronium bromide or vecuronium bromide has been given, and also in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been given for moderate to heavy muscle relaxation.

2. Important information before using Sugammadex Zentiva

When not to use Sugammadex Zentiva:

In this case, inform your anesthesiologist.

Warnings and precautions

Before Sugammadex Zentiva is given, discuss with your anesthesiologist

Children and adolescents

It is not recommended to use this medicine in infants under 2 years of age.

Sugammadex Zentiva 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 Zentiva may affect the action of other medicines, or other medicines may affect the action of Sugammadex Zentiva.

Some medicines reduce the effectiveness of Sugammadex Zentiva

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

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

Sugammadex Zentiva may affect the effectiveness of hormonal contraceptives

Sugammadex Zentiva may reduce the effectiveness of hormonal contraceptives, including "the pill", vaginal ring, implant, or intrauterine system releasing progestogen (hormonal intrauterine device), because it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex Zentiva is roughly equivalent to missing one contraceptive pill.

otherhormonal contraceptives (such as a vaginal ring, implant, or hormonal intrauterine device), use an additional non-hormonal contraceptive method (e.g., condoms) for the next 7 days and follow the instructions in the package leaflet of the specific medicine.

Effect on laboratory test results

Sugammadex Zentiva usually does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. Inform your doctor if the progesterone level in the blood should be tested on the same day that Sugammadex Zentiva is given.

Pregnancy, breastfeeding, and fertility

Inform your anesthesiologist if the patient is pregnant or may be pregnant, or if the patient is breastfeeding. The patient can still be given Sugammadex Zentiva, 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 baby and the benefits of treatment with Sugammadex Zentiva for the mother.

Driving and using machines

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

Sugammadex Zentiva contains sodium

The medicine contains 9.7 mg of sodium (main component of common salt/sodium chloride) per 1 mL of solution for injection. Dose less than or equal to 2.4 mL: The medicine contains less than 1 mmol (23 mg) of sodium per dose of 2.4 mL (or less), which means the medicine is considered "sodium-free". Dose greater than 2.4 mL: The medicine contains 23 mg (or more) of sodium (main component of common salt) per dose of 2.4 mL (or more). This corresponds to 1.15% (or more) of the maximum recommended daily sodium intake in adults.

3. How Sugammadex Zentiva is given

Sugammadex Zentiva will be given to the patient by an anesthesiologist or under the supervision of an anesthesiologist.

Dose

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

• body weight
• dose of muscle relaxant used.

The usual dose is from 2 mg/kg body weight to 4 mg/kg body weight in adults and children and adolescents aged 2-17 years. If rapid recovery of muscle function is necessary, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Zentiva is given

Sugammadex Zentiva is given by an anesthesiologist as a single injection through an intravenous line.

If more Sugammadex Zentiva is given than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Zentiva will occur. Nevertheless, in the event of an overdose, no problems are expected to occur. 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, Sugammadex Zentiva 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
• Difficulty breathing, including coughing or moving, such as when waking up or taking a breath
• Mild sedation - the patient may start to wake up from deep sleep and need more anesthetic. This can cause movement or coughing at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing, or moving
• Decreased blood pressure related to the surgical procedure

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

• 100)
• Shortness of breath due to bronchospasm (constriction of airways) 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 reactions similar to allergic reactions can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers
• Return of muscle relaxation after surgery

Rare side effects(frequency cannot be estimated from available data)

• Severe cases of slow heart rate, including slow heart rate up to cardiac arrest, have been reported after Sugammadex Zentiva administration

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 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 Zentiva

The medicine will be stored by healthcare professionals. Store the medicine 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 any special storage precautions. Store the vials in the outer packaging to protect from light. After first opening and dilution, store in a refrigerator (2°C - 8°C) and use within 24 hours.

6. Contents of the pack and other information

What Sugammadex Zentiva contains

• The active substance is sugammadex. 1 mL of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex. Each 2 mL vial contains sugammadex sodium equivalent to 200 mg of sugammadex. Each 5 mL vial contains sugammadex sodium equivalent to 500 mg of sugammadex.
• The other ingredients are: water for injections, hydrochloric acid (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What Sugammadex Zentiva looks like and contents of the pack

Sugammadex Zentiva is a clear, colorless to slightly yellowish-brown solution for injection, practically free from particles. It is available in two different pack sizes, containing 10 vials of 2 mL or 10 vials of 5 mL solution for injection. Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Synthon Hispania S.L., Calle de Castello 1, Poligono Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain; Synthon B.V., Microweg 22, 6545 CM Nijmegen, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France: SUGAMMADEX ZENTIVA 100 mg/ml, solution injectable; Netherlands: Sugammadex Zentiva 100 mg/mL, oplossing voor injectie; Germany: Sugammadex Zentiva 100 mg/ml Injektionslösung; Portugal: Sugammadex Zentiva 100 mg/mL; Poland, Italy, Sweden, Czech Republic: Sugammadex Zentiva

For more information about this medicine, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00; Date of last revision:March 2025