Sugammadex Iuta

Package Leaflet: Information for the User

Sugammadex Juta, 100 mg/mL, Solution for Injection

Sugammadex

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

Table of Contents of the Leaflet

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

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

What is Sugammadex Juta

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

What is Sugammadex Juta used for

In case of certain 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 administered during general anesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Since these drugs also cause relaxation of the respiratory muscles, assisted breathing (mechanical ventilation) is necessary during and after the operation until the patient's own breathing returns. Sugammadex Juta is used to accelerate the return of muscles to their normal state after surgery, allowing the patient to breathe on their own earlier. Its action involves 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 using Sugammadex Juta

When not to use Sugammadex Juta

allergicto sugammadex or any of the other ingredients of this medicine (listed in section 6). In this case, inform your anesthesiologist.

Warnings and precautions

Before using Sugammadex Juta, discuss with your anesthesiologist:

Children and adolescents

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

Sugammadex Juta 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 Juta may affect the action of other medicines or other medicines may affect the action of Sugammadex Juta.

Some medicines reduce the effectiveness of Sugammadex Juta

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

• Toremifene (used in breast cancer treatment).
• Fusidic acid (an antibiotic).

Sugammadex Juta may affect the effectiveness of hormonal contraceptives

Sugammadex Juta 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 Juta is roughly equivalent to missing one contraceptive pill.

• In case of taking the "pill"on the same day that Sugammadex Juta is administered, follow the instructions for missing a pill contained in the hormonal contraceptive leaflet,
• In case of using other hormonal 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 recommendations contained in the leaflet for the specific product.

Effect on blood test results

Normally, Sugammadex Juta 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 is to be tested on the same day that Sugammadex Juta is administered.

Pregnancy and breastfeeding

Inform your anesthesiologist if the patient is pregnant or may be pregnant or if she is breastfeeding. The patient can still be given Sugammadex Juta, 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 Juta for the mother.

Driving and using machines

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

Sugammadex Juta 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 Sugammadex Juta is administered

Sugammadex Juta 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 Juta based on:

• body weight
• the 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. If rapid recovery of muscle tension to the normal state is necessary, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Juta is administered

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

If more Sugammadex Juta is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Juta 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 or pharmacist.

4. Possible side effects

Like all medicines, Sugammadex Juta can cause side effects, although not everybody gets them. If these side effects occurduring anesthesia, they will be noticed and treatedby 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 anesthesia - the patient may start to wake up from deep sleep and need more anesthetic. This may 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)

• 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, difficulty breathing, 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. The occurrence of allergic reactions has been reported more frequently in healthy, conscious volunteers

Return of muscle tension to the normal state after surgery

• Unknown frequency
• Possible severe cases of bradycardia, including bradycardia leading to cardiac arrest, after administration of Sugammadex Juta

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your anesthesiologist, another doctor, or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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 Juta

Keep this medicine out of the 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. The medicine will be stored by medical personnel. There are no special storage temperature recommendations for this medicine. Vials should be stored in the outer packaging to protect from light. Do not freeze. 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 Juta contains

• The active substance is sugammadex. 1 mL of the 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, and/or sodium hydroxide.

What Sugammadex Juta looks like and contents of the pack

Sugammadex Juta is a clear solution for injection, colorless to slightly yellow. It is available in two different pack sizes containing 1 vial, 5 vials, or 10 vials of 2 mL or 1 vial, 5 vials, or 10 vials of 5 mL of the solution for injection. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Juta Pharma GmbH, Gutenbergstraße 13, 24941 Flensburg, Germany, [email protected]

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

For detailed information, refer to the Summary of Product Characteristics for Sugammadex Juta.