Sugammadex Aguettant

Patient Information Leaflet

Sugammadex Aguettant 50 mg/mL solution for injection in pre-filled syringe, 10 mg/mL solution for injection in pre-filled syringe

sugammadex
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your anaesthetist or doctor.
• If you experience any side effects, including those not listed in this leaflet, inform your anaesthetist or doctor. See section 4.

Contents of this leaflet

1. What Sugammadex Aguettant is and what it is used for
2. What you need to know before Sugammadex Aguettant is administered
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 Sugammadex Aguettant is and what it is used for

What Sugammadex Aguettant is
Sugammadex Aguettant contains the active substance sugammadex.
Sugammadex Aguettant is considered a Selective Muscle Relaxant Binding Agent because it binds only to specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What Sugammadex Aguettant is used for
During certain types of surgery, muscles need to be completely relaxed. This makes it easier for the surgeon to perform the procedure. To achieve this, muscle-relaxing medicines, known as neuromuscular blocking agents, are added to general anaesthesia. These include rocuronium bromide and vecuronium bromide. Since these medicines also relax the muscles that control breathing, assistance with breathing (so-called artificial ventilation) is required during and after surgery, until you are able to breathe on your own again.

Sugammadex Aguettant is used to speed up muscle recovery after surgery, allowing you to breathe on your own again as soon as possible. It works by binding to rocuronium bromide or vecuronium bromide present in the body.

It can be used in adults whenever rocuronium bromide or vecuronium bromide is used, and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before Sugammadex Aguettant is administered

Do not receive Sugammadex Aguettant

• if you are allergic to sugammadex or to any of the ingredients of this medicine (listed in section 6). → Inform your anaesthetist if this applies to you.

Warnings and precautions
Talk to your anaesthetist before Sugammadex Aguettant is administered

• If you have or have previously had kidney disease. This is important because sugammadex is eliminated from the body through the kidneys.
• If you have or have previously had liver disease.
• If you have fluid retention (oedema).
• If you have diseases known to increase the risk of bleeding (blood coagulation disorders) or if you are receiving anticoagulant therapy.

Children and adolescents
This medicine is not recommended for children under 2 years of age.
Other medicines and Sugammadex Aguettant
→ Inform your anaesthetist if you are taking, have recently taken, or might take any other
medicines. Sugammadex Aguettant may affect or be affected by other medicines.
Some medicines reduce the effect of Sugammadex Aguettant
→ It is particularly important that you inform your anaesthetist if you have recently taken:

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

Sugammadex Aguettant may affect hormonal contraceptives

• Sugammadex Aguettant may reduce the effectiveness of hormonal contraceptives (including oral contraceptive pills, vaginal ring, implants, or a hormonal intrauterine system (IUS, Intra Uterine System)), as it reduces the amount of absorbed progestogenic hormone. The amount of progestogen lost when Sugammadex Aguettant is administered is approximately equivalent to that of a missed contraceptive pill dose. → If you need to take your oral contraceptive pill on the same day that Sugammadex Aguettant is administered, follow the instructions provided in the contraceptive pill’s package leaflet regarding a missed dose. → If you are using other hormonal contraceptives (e.g., a vaginal ring, implant, or IUS), you must use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the instructions in the product leaflet.

Effects on blood test results
Generally, Sugammadex Aguettant has no effect on blood test results. However, it may
affect the results of a test measuring blood levels of a hormone called progesterone.
Talk to your doctor if testing of progesterone levels is required on the same day you receive Sugammadex Aguettant.
Pregnancy and breastfeeding
Inform your anaesthetist if you are pregnant or could be pregnant, or if you are breastfeeding.
You may still receive Sugammadex Aguettant, but you must discuss this with your doctor first.
It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to discontinue breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the infant and the benefits of Sugammadex Aguettant for the mother.
Driving and using machines
Sugammadex Aguettant has no known influence on the ability to drive vehicles or operate machinery.
Sugammadex Aguettant contains sodium
Each 5 mL pre-filled syringe contains 30.8 mg of sodium (the main component of table salt).
This corresponds to 1.5% of the maximum daily recommended dietary intake for an adult.
Each 10 mL pre-filled syringe contains 42.6 mg of sodium (the main component of table salt).
This corresponds to 2.1% of the maximum daily recommended dietary intake for an adult.

3. How Sugammadex Aguettant is administered

Sugammadex Aguettant will be administered to you by an anaesthetist or under the supervision of an anaesthetist.
The dose
The anaesthetist will determine the appropriate dose of Sugammadex Aguettant for you, taking into consideration:

• your body weight
• the extent to which the muscle relaxant is still acting on you.

The pre-filled syringe containing 100 mg/10 mL is more suitable for children and adults weighing less than 50 kg. For higher doses or for patients weighing more than 50 kg, other presentations or formulations are available.

The usual dose is 2–4 mg per kg of body weight in adults and in children and adolescents aged between 2 and 17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.
How Sugammadex Aguettant is administered
Sugammadex Aguettant will be administered by the anaesthetist as a single intravenous injection (into a vein).
If you are given more Sugammadex Aguettant than you should have
Since the anaesthetist will closely monitor your condition, it is unlikely that you will receive an excessive amount of Sugammadex Aguettant. However, if this were to happen, it is unlikely to cause you any problems.
If you have any doubts about the use of this medicine, consult your anaesthetist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If such side effects occur during anaesthesia, they will be detected and treated by the anaesthetist.

Common side effects (may affect up to 1 in 10 people)

• Cough
• Breathing difficulties which may include coughing or movements as if waking up or gasping for breath
• Light anaesthesia – you may begin to come out of deep sleep, and therefore may require additional anaesthetic. This could cause the patient to move or cough at the end of the operation
• Complications during the procedure such as changes in heart rate, coughing or movements
• Decrease in blood pressure due to the surgical procedure

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

• In patients with a history of lung problems, shortness of breath due to muscular contractions of the airways (bronchospasm) has been observed
• Allergic reactions (hypersensitivity to the medicine), such as skin rash, red skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, which sometimes may lead to severe drop in blood pressure. Severe allergic or allergy-like reactions can be life-threatening. Allergic reactions have been reported more commonly in healthy, awake volunteers
• Return of muscle relaxation after the operation.

Frequency not known

• When sugammadex is administered, severe slowing of the heart and slowing of the heart leading to cardiac arrest may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to the anaesthetist or your doctor. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Aguettant

Storage will be managed by healthcare professionals.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and syringe label after "Exp.". The expiry date refers to the last day of that month.
Do not freeze.
Store the syringe in its carton to protect the medicine from light.
Keep the pre-filled syringe in its intact blister until use.
After first opening, the medicine must be used immediately.
Pre-filled syringes, even if partially used, must be appropriately discarded after use.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sugammadex Aguettant contains

• The active substance is sugammadex. Each mL of injectable solution contains sodium sugammadex equivalent to 50 mg of sugammadex. Each 5 mL pre-filled syringe contains sodium sugammadex equivalent to 250 mg of sugammadex.

Each mL of injectable solution contains sodium sugammadex equivalent to 10 mg of
sugammadex.
Each 10 mL pre-filled syringe contains sodium sugammadex equivalent to 100 mg of
sugammadex.

• The other components are sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH), and water for injections.

Description of the appearance of Sugammadex Aguettant and contents of the pack
Sugammadex Aguettant is a clear, colourless to pale yellow injectable solution in a 5 mL pre-filled
polypropylene syringe, with a transparent self-adhesive graduated label (marks every 0.2 mL from 0 to 5 mL). Each pre-filled syringe is individually packaged in a transparent blister.
Sugammadex Aguettant is a clear, colourless to pale yellow injectable solution in a 10 mL pre-filled
polypropylene syringe, with a transparent self-adhesive graduated label (marks every 0.5 mL from 0 to 10 mL). Each pre-filled syringe is individually packaged in a transparent blister.
Available in cardboard boxes containing 10 pre-filled syringes.

Marketing Authorisation Holder and Manufacturer
Laboratoire Aguettant
1, rue Alexander Fleming
69007 Lyon
France

This medicinal product is authorised in the European Economic Area Member States under the
following names:
AT, BE, DK, FI, FR, DE, HU, IT, NL, NO, PL, RO, ES, SE: Sugammadex Aguettant
IE: Sugammadex
PT: Sugamadex Aguettant

The following information is intended exclusively for healthcare professionals:

Please prepare the syringe carefully as follows:
The pre-filled syringe is intended for single patient use only. Discard the syringe after use. DO NOT
REUSE.
The contents of an unopened and undamaged blister are sterile, and the blister must not be opened until
the syringe is ready for use.
The product should be inspected visually for the presence of particulate matter and discoloration
prior to administration. Only a clear, colorless to pale yellow solution, free from particles or precipitate,
should be used.
The product must not be used if the tamper-evident seal on the syringe is broken.
Do not use the medicinal product if visible signs of deterioration are present.
The outer surface of the syringe is sterile until the blister is opened. The blister must not be opened until
immediately before use.
When handled using an aseptic technique, once removed from the blister, this medicinal product may
be placed on a sterile field.
The volume to be administered must be calculated according to the appropriate dosage.

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

2. Push the plunger to release the stopper. The sterilization
   process may have caused the stopper to adhere to the barrel
   of the syringe.

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

4. Check that the syringe seal tip has been completely removed.
   If not, replace the cap and unscrew again.

5. Expel air by gently pushing the plunger.
6. Connect the syringe to the vascular access device using a luer/luer lock connection system. Push the
   plunger slowly to inject the required volume. Administer the product according to the appropriate route of administration.
   The pre-filled syringe is not suitable for use with automatic syringe pumps. The pre-filled syringe is a ready-to-use product.
   Damaged syringes or those handled without maintaining sterility must not be used.
   Any unused medicinal product and waste material derived from this medicinal product should be disposed of in accordance with local regulations.