Sugammadex aguettant

Package leaflet: Information for the patient

Sugammadex Aguettant, 10 mg/mL, solution for injection in vial-syringe
Sugammadex Aguettant, 50 mg/mL, solution for injection in vial-syringe
Sugammadexum
Please read this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your anaesthesiologist or another doctor.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your anaesthesiologist or another doctor immediately. See section 4.

Leaflet contents

1. What is Sugammadex Aguettant and what is it used for
2. Important information before receiving 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 agent, because it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.
Why is Sugammadex Aguettant used
During certain types of surgery, the patient's muscles must be completely relaxed to allow the surgeon to perform the procedure more easily. For this purpose, muscle relaxants are administered during general anaesthesia. These are known as neuromuscular blocking agents, and include rocuronium bromide and vecuronium bromide.
Since these drugs also relax the respiratory muscles, assisted breathing (mechanical ventilation) is required during and after surgery until the patient regains spontaneous respiration.
Sugammadex Aguettant is used to accelerate the recovery of muscle function after surgery, enabling the patient to breathe independently sooner. It works by binding to rocuronium bromide or vecuronium bromide in the body.
The medicine may be used in adults when rocuronium bromide or vecuronium bromide has been administered, and also in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been used to achieve moderate neuromuscular blockade.

2. Important information before administration of Sugammadex Aguettant

When not to administer Sugammadex Aguettant

• if the patient is allergic to sugammadex or to any of the other ingredients of this medicine (listed in section 6). → In such case, inform the anaesthesiologist.

Warnings and precautions
Before administration of Sugammadex Aguettant, discuss the following with the anaesthesiologist:

• if the patient has or has had kidney disease in the past. This is important because sugammadex is eliminated from the body via the kidneys.
• if the patient currently has or has had liver disease in the past.
• if the patient has fluid retention (edema).
• if the patient has disorders known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medicines.

Children and adolescents
This medicine is not recommended for use in infants under 2 years of age.
Sugammadex Aguettant and other medicines
Inform the anaesthesiologist about all medicines the patient is currently 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 particularly important to inform the anaesthesiologist if the following medicines have been taken recently:

• toremifene (used in the treatment of 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 oral contraceptives ("the pill"), vaginal contraceptive system, implant, or hormonal intrauterine device, because it reduces the amount of the progestogen hormone delivered. The amount of progestogen lost due to administration of Sugammadex Aguettant is approximately equivalent to missing one oral contraceptive tablet.
• If taking "the pill" on the same day that Sugammadex Aguettant is administered, follow the instructions for missed dose provided in the patient information leaflet of the hormonal contraceptive.
• If using other hormonal contraceptives (such as a vaginal contraceptive system, implant, or hormonal intrauterine device), use an additional non-hormonal method of contraception (e.g. condoms) for the next 7 days and follow the recommendations provided in the product leaflet of the respective contraceptive.

Effect on blood test results
Sugammadex Aguettant usually does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Consult the doctor if progesterone levels need to be measured on the same day that Sugammadex Aguettant is administered.
Pregnancy and breastfeeding
Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Aguettant may still be used in pregnant patients, but this should be discussed with the doctor.
It is unknown whether sugammadex passes into human milk. The anaesthesiologist will help the patient decide whether to discontinue breastfeeding or to withhold treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Aguettant for the mother.
Driving and operating machinery
Sugammadex Aguettant has no known effect on the ability to drive or operate machinery.
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 table salt).
This corresponds to 1.5% of the maximum recommended daily dietary intake of sodium 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 table salt).
This corresponds to 2.1% of the maximum recommended daily dietary intake of sodium for adults.

3. How is Sugammadex Aguettant administered

Sugammadex Aguettant will be administered to the patient by an anaesthesiologist or under the supervision of an anaesthesiologist.
Dosage
The anaesthesiologist will adjust the dose of Sugammadex Aguettant based on:

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

The 100 mg/10 mL vial-syringe is more suitable for children and adults with body weight below 50 kg.
For higher doses or body weight above 50 kg, other presentations or preparations are available.
The usual recommended dose ranges from 2 mg/kg to 4 mg/kg body weight in adults as well as in children and adolescents aged 2–17 years. If rapid reversal of neuromuscular blockade is urgently required, a dose of 16 mg/kg body weight may be administered in adults.
How Sugammadex Aguettant is administered
Sugammadex Aguettant is administered by the anaesthesiologist as a single intravenous injection through an intravenous line (into a vein).
If more Sugammadex Aguettant has been administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Aguettant is unlikely. Nevertheless, even if such an event occurs, no complications are expected.
If you have any further questions regarding the use of this medicine, please consult the anaesthesiologist or another physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If these adverse reactions occur during anaesthesia, they will be noticed and treated by the anaesthesiologist.

Common adverse reactions (may occur in up to 1 in 10 people)

• Coughing
• Breathing difficulties, including coughing or movement, such as during emergence or in response to breathing
• Light anaesthesia – the patient may begin to wake from deep sleep and require additional anaesthetic. This may cause movement or coughing towards the end of surgery
• Intraoperative complications, such as changes in heart rate, coughing or movement
• Decreased blood pressure related to the surgical procedure

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Shortness of breath due to bronchial muscle spasms (bronchospasm) in patients with a history of lung disease
• Allergic reactions (hypersensitivity to the medicine) – such as rash, redness of the skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rhythm, sometimes leading to severe drop in blood pressure. Severe allergic or allergic-like reactions may be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers.
• Return of muscle weakness after surgery

Frequency not known

• Following administration of Sugammadex Aguettant, severe cases of bradycardia, as well as slowing of the heart rate up to and including cardiac arrest, are possible

Reporting of adverse reactions
If any adverse reactions occur in a patient, including any possible adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sugammadex Aguettant

Sugammadex Aguettant will be stored by healthcare personnel.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and prefilled syringe label after "EXP". The expiry date refers to the last day of the stated month.
Do not freeze.
Store the prefilled syringes in their original packaging to protect from light.
Keep the prefilled syringe in the unopened blister until the time of use.
After opening, the medicinal product must be used immediately.
Each syringe, even if partially used, should be properly disposed of after use.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Sugammadex Aguettant contains

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

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

• Other ingredients include: sodium chloride, hydrochloric acid concentrated (for pH adjustment), sodium hydroxide (for pH adjustment) 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 scale label (graduations every 0.5 mL from 0 to 10 mL). Each pre-filled syringe is individually packed in a transparent blister within 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 scale label (graduations every 0.2 mL from 0 to 5 mL). Each pre-filled syringe is individually packed in a transparent blister within a cardboard box.
Cartons containing 10 pre-filled syringes are available.
Marketing Authorisation Holder and Manufacturer
LABORATOIRE AGUETTANT
1, rue Alexander Fleming
69007 Lyon
France

Information intended exclusively for medical professionals:

The syringe must be carefully prepared as follows:
The pre-filled syringe is intended for use in a single patient only. After use, it must be
discarded. DO NOT REUSE.
The contents of an unopened and undamaged blister are sterile; therefore, do not open the
blister until the syringe is ready for use.
Before administration, inspect the solution for particles and discoloration. Only use a clear,
colourless to slightly yellow solution, free from particles or precipitates.
Do not use the product if the tamper-evident seal on the syringe is damaged.
Do not use this medicinal product if visible signs of deterioration in quality are observed.
The outer surface of the syringe is sterile until the blister is opened. Do not open the blister
before use.
When handling this medicine under aseptic conditions, it may be placed on a sterile field after
removal from the blister.
The volume to be administered should be calculated according to the appropriate dosing.

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

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

3. Unscrew the end cap to break the tamper-evident seal.
   Do not touch the exposed Luer connector to avoid contamination.

4. Check whether the syringe tip protector has been completely removed. If not, reattach the protector and twist again.

5. Expel air by gently pressing the plunger.
6. Connect the syringe to the intravenous access using a Luer/Luer lock system. Slowly depress the plunger to inject the required volume. Administer the product via the appropriate route of administration.
   The pre-filled syringe is not suitable for use with infusion pumps. The pre-filled syringe contains a ready-to-administer product.
   Do not use the pre-filled syringe if it has been damaged or handled without maintaining sterility.
   Any unused medicinal product or waste material should be disposed of in accordance with local regulations.