Sugammadex Aguettant

Leaflet attached to the packaging: patient information

Sugammadex Aguettant, 10 mg/mL, solution for injection in a pre-filled syringe

Sugammadex Aguettant, 50 mg/mL, solution for injection in a pre-filled syringe

Sugammadex

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult an anesthesiologist or another doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the anesthesiologist or another doctor. See section 4.

Table of contents of the leaflet

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

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

What is Sugammadex Aguettant

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

What is Sugammadex Aguettant used for

In the 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 referred to as muscle relaxantsand include rocuronium bromide and vecuronium bromide. Since these medications 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 Aguettant is used to accelerate the return of muscles to their normal state after surgery, allowing the patient to breathe on their own sooner. Its action involves binding to rocuronium bromide or vecuronium bromide in the body. The medication 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 administering Sugammadex Aguettant

When not to administer Sugammadex Aguettant

Warnings and precautions

Before administering Sugammadex Aguettant, discuss it with the anesthesiologist

Children and adolescents

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

Sugammadex Aguettant and other medications

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

Certain medications reduce the effectiveness of Sugammadex Aguettant

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

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

Sugammadex Aguettant may affect the effectiveness of hormonal contraceptives

• Sugammadex Aguettant may reduce the effectiveness of hormonal contraceptives, including "the pill", vaginal ring, implant, or intrauterine device with a hormone, because it reduces the amount of progestogen delivered. The amount of progestogen lost due to the use of Sugammadex Aguettant is roughly equivalent to missing one contraceptive pill.
• In the case of taking "the pill" on the same day that Sugammadex Aguettant is administered, follow the instructions for missing a pill, as stated in the hormonal contraceptive leaflet.
• In the case of using otherhormonal contraceptives (such as a vaginal ring, implant, or intrauterine device with a hormone), 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 medication.

Effect on blood test results

Usually, Sugammadex Aguettant does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. If the progesterone level in the blood needs to be tested on the same day that Sugammadex Aguettant is administered, consult a doctor.

Pregnancy and breastfeeding

Inform the anesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding. The patient can still be given Sugammadex Aguettant, but this should be discussed with the doctor. It is not known whether sugammadex passes into human 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 Aguettant for the mother.

Driving and using machines

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

Sugammadex Aguettant contains sodium

Sugammadex Aguettant, 50 mg/mL
Each 5 mL pre-filled syringe contains up to 30.8 mg of sodium (the main component of common salt). This corresponds to 1.5% of the maximum recommended daily intake of sodium in the diet for adults. Sugammadex Aguettant, 10 mg/mL
Each 10 mL pre-filled syringe contains up to 42.6 mg of sodium (the main component of common salt). This corresponds to 2.1% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Sugammadex Aguettant is administered

Sugammadex Aguettant 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 Aguettant based on:

• the patient's body weight
• the dose of muscle relaxant used.

A pre-filled syringe containing 100 mg/10 mL is more suitable for children and adults with a body weight below 50 kg. For large doses or weights above 50 kg, other forms or preparations are available. 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 is necessary, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Aguettant is administered

Sugammadex Aguettant is administered by an anesthesiologist. It is given as a single injection through an intravenous line (into a vein).

If more Sugammadex Aguettant is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Aguettant will occur. Nevertheless, in the event of such an occurrence, no complications should arise. In case of any further doubts regarding the use of this medication, consult an anesthesiologist or another doctor.

4. Possible side effects

Like all medications, this medication 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.

Common 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 waking 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)

• Shortness of breath associated with bronchospasm in patients with a history of lung disease
• Allergic reactions (hypersensitivity to the medication) - such as rash, skin redness, tongue and/or throat swelling, shortness of breath, changes in blood pressure or heart rhythm, 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

Frequency not known

• After administration of Sugammadex Aguettant, severe cases of bradycardia, as well as bradycardia leading to cardiac arrest, are possible

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal 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 medication.

5. How to store Sugammadex Aguettant

The medication will be stored by healthcare professionals. The medication should be stored out of sight and reach of children. Do not use this medication after the expiration date stated on the carton, blister, and pre-filled syringe label after "EXP". The expiration date refers to the last day of the specified month. Do not freeze. Store the pre-filled syringes in their original packaging to protect them from light. Store the pre-filled syringe in an unopened blister until use. After opening, the medicinal product should be used immediately. Each pre-filled syringe, even if partially used, should be disposed of properly after use. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sugammadex Aguettant contains

• The active substance of the medication is sugammadex. Sugammadex Aguettant, 10 mg/mLEach mL of the solution for injection contains sugammadex sodium equivalent to 10 mg of sugammadex. Each 10 mL pre-filled syringe contains sugammadex sodium equivalent to 100 mg of sugammadex.

Sugammadex Aguettant, 50 mg/mL
Each mL of the solution for injection contains sugammadex sodium equivalent to 50 mg of sugammadex. Each 5 mL pre-filled syringe contains sugammadex sodium equivalent to 250 mg of sugammadex.

• Other ingredients are: sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and water for injections.

What Sugammadex Aguettant looks like and what the package contains

Sugammadex Aguettant, 10 mg/mL
Sugammadex Aguettant is a clear solution for injection, colorless to slightly yellow, in a 10 mL pre-filled syringe (made of polypropylene) with a self-adhesive, transparent label with a scale (scale every 0.5 mL from 0 to 10 mL). Each pre-filled syringe is packaged individually in a transparent blister, in a cardboard box. Sugammadex Aguettant, 50 mg/mL
Sugammadex Aguettant is a clear solution for injection, colorless to slightly yellow, in a 5 mL pre-filled syringe (made of polypropylene) with a self-adhesive, transparent label with a scale (scale every 0.2 mL from 0 to 5 mL). Each pre-filled syringe is packaged individually in a transparent blister, in a cardboard box. Cardboard boxes containing 10 pre-filled syringes are available.

Marketing authorization holder and manufacturer

LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France

Date of last update of the leaflet:

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Information intended only for healthcare professionals:
The pre-filled syringe should be carefully prepared as follows:
The pre-filled syringe is intended for use in a single patient only. After use, it should be discarded. DO NOT REUSE IT.
The contents of the unopened and undamaged blister are sterile, so do not open the blister until the syringe is ready for use.
Before administration, inspect the product for particles and discoloration. Only use a clear, colorless to slightly yellow solution that is free of particles or precipitates.
Do not use the product if the protective cap on the syringe is damaged.
Do not use this medication if visible signs of deterioration are observed.
The outer surface of the syringe is sterile until the blister is opened. The blister should not be opened until use.

• 1) Remove the sterile pre-filled syringe from the blister.

• 2) Press the plunger to release the rubber stopper. The sterilization process may have caused the rubber stopper to stick to the syringe body.

• 3) Unscrew the tip cap to break the seal. Do not touch the exposed luer connection to avoid contamination.

• 4) Check that the tip cap has been completely removed. If not, put the cap back on and twist it again.

• 5) Expel air by gently pressing the plunger.

• 6) Connect the syringe to the intravenous access using a luer/luer lock system. Slowly press the plunger to inject the required volume. Administer the product according to the recommended route of administration.

The pre-filled syringe is not suitable for use with infusion pumps. The pre-filled syringe contains a ready-to-use product. Do not use a pre-filled syringe that has been damaged or handled without maintaining sterile conditions. Any unused medicinal product or waste should be disposed of in accordance with local regulations.