Sugammadex Aguettant

Leaflet accompanying 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 administering 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 anaesthetist or another doctor.
• If you experience any side effects, including any not listed in this leaflet, tell your anaesthetist 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. Contents of the pack 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 certain muscle relaxants - rocuronium bromide or vecuronium bromide.

What is Sugammadex Aguettant 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 administered during general anaesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Because 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 Aguettant is used to accelerate the recovery of muscles 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 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 years) 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 your anaesthetist

Children and adolescents

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

Sugammadex Aguettant and other medicines

Tell your anaesthetist about all medicines the patient is taking, has recently taken, or plans to take. Sugammadex Aguettant may affect the action of other medicines, or other medicines may affect the action of Sugammadex Aguettant.

Some medicines reduce the effectiveness of Sugammadex Aguettant

→ It is especially important to inform the anaesthetist if the patient has taken the following medicines 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.

Effect on laboratory 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 is to be tested on the same day that Sugammadex Aguettant is administered, inform your doctor.

Pregnancy and breastfeeding

Inform your anaesthetist 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 anaesthetist 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 anaesthetist, or under the supervision of an anaesthetist.

Dose

The anaesthetist 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 weighing less than 50 kg. For higher doses or weights above 50 kg, other formulations 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 years. If rapid recovery of muscle tension is necessary after relaxation, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Aguettant is administered

Sugammadex Aguettant is administered by an anaesthetist. It is given as a single injection through a vein (intravenously).

If more Sugammadex Aguettant is administered than recommended

Because the anaesthetist 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. If you have any further questions about the use of this medicine, ask your anaesthetist 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 anaesthesia, they will be noticed and treated by the anaesthetist.

Common side effects (may affect 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 anaesthetic. 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 affect 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 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

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Aguettant

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, blister, and pre-filled syringe label after "EXP". The expiry date refers to the last day of the month. Do not freeze. Store the pre-filled syringes in their original packaging to protect them from light. Store the pre-filled syringe in its unopened blister until use. The medicinal product should be used immediately after opening. Each pre-filled syringe, even if partially used, should be disposed of properly after use. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sugammadex Aguettant contains

• The active substance is sugammadex. Sugammadex Aguettant, 10 mg/mLEach mL of 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 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.

• The 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 contents of the pack

Sugammadex Aguettant, 10 mg/mL
Sugammadex Aguettant is a clear solution for injection, colourless to slightly yellow, in a 10 mL pre-filled syringe (made of polypropylene) with a self-adhesive, transparent label with a scale (scale in 0.5 mL increments 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, colourless to slightly yellow, in a 5 mL pre-filled syringe (made of polypropylene) with a self-adhesive, transparent label with a scale (scale in 0.2 mL increments 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 authorisation holder and manufacturer

LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:
The pre-filled syringe should be carefully prepared as follows:
The pre-filled syringe is intended for single use only. After use, it should be discarded. DO NOT REUSE.
The contents of the unopened and undamaged blister are sterile, so do not open the blister until the pre-filled syringe is ready for use.
Before administration, the product should be inspected for particles and discolouration. Only use a clear, colourless to slightly yellow solution that is free from particles or precipitates.
Do not use the product if the protective cap on the pre-filled syringe is damaged.
Do not use this medicine if visible signs of deterioration are observed.
The outer surface of the pre-filled syringe is sterile until the blister is opened. The blister should not be opened until use.
When handling this medicine using aseptic technique, after removal from the blister, it can be placed on a sterile field.
The volume to be administered should be calculated based on the recommended dosing.

• 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 pre-filled syringe body.

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

• 4) Check that the tip cap of the pre-filled syringe 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 pre-filled 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 material should be disposed of in accordance with local requirements.