Sugammadex Accord

Package Leaflet: Information for the Patient

Sugammadex Accord, 100 mg/mL, Solution for Injection

Sugammadex

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

Keep this package 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 package leaflet, inform the anesthesiologist or another doctor. See section 4.

Package Leaflet Contents

What is Sugammadex Accord and what is it used for
Important information before taking Sugammadex Accord
How to take Sugammadex Accord
Possible side effects
How to store Sugammadex Accord
Contents of the pack and other information

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

What is Sugammadex Accord

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

What is Sugammadex Accord 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 Accord is used to accelerate the recovery of muscles 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 years) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before taking Sugammadex Accord

When not to take Sugammadex Accord

if the patient is allergic to sugammadex or any of the other ingredients of this medication (listed in section 6).
In such cases, inform the anesthesiologist.

Warnings and precautions

Before starting treatment with Sugammadex Accord, discuss it with the anesthesiologist:

• if the patient has or has had kidney disease in the past. This is important because Sugammadex Accord is eliminated from the body through the kidneys.
• if the patient has or has had liver disease.
• if the patient has fluid retention in the body (edema).
• if the patient has conditions known to increase the risk of bleeding (blood clotting disorders) or is taking anticoagulant medications.

Children and adolescents

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

Sugammadex Accord and other medications

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

Certain medications reduce the effectiveness of Sugammadex Accord

It is particularly 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 Accord may affect the effectiveness of hormonal contraceptives

Sugammadex Accord 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 Accord is roughly equivalent to missing one contraceptive pill.
If "the pill" is taken on the same day that Sugammadex Accord is administered, follow the instructions for missing a pill in the hormonal contraceptive package leaflet.
When using otherhormonal 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 in the package leaflet of the specific contraceptive.

Effect on blood test results

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult the anesthesiologist before taking this medication.
The patient can still be given Sugammadex Accord, 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 Accord for the mother.

Driving and using machines

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

Sugammadex Accord contains sodium

The medication contains up to 9.7 mg of sodium (the main component of common salt) per milliliter.
Dose of 2.4 mL or less
A dose of 2.4 mL (or less) contains less than 1 mmol of sodium (23 mg), which is considered "sodium-free".
Dose above 2.4 mL
A dose of 2.4 mL (or more) contains 1 mmol (or more) of sodium (23 mg). This corresponds to 1.15% (or more) of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Sugammadex Accord

Sugammadex Accord will be administered to the patient by the anesthesiologist or under the supervision of the anesthesiologist.

Dose

The anesthesiologist will adjust the dose of sugammadex based on:

• the patient's body weight,
• the severity of muscle relaxation in the patient.

Typically, the dose used is from 2 mg/kg of body weight to 4 mg/kg of 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 of body weight can be used in adults.

How Sugammadex Accord is administered

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

Overdose of Sugammadex Accord

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

4. Possible side effects

Like all medications, Sugammadex Accord 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 less than 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 therefore need more anesthetic. This may result in 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 less than 1 in 100 people)

• Shortness of breath due to bronchospasm in patients with a history of lung disease.
• Allergic reactions (hypersensitivity to the medication) - 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 relaxation after surgery.

Frequency not known(frequency cannot be estimated from the available data)

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

Reporting side effects

If side effects occur, including any side effects not listed in the package leaflet, inform the doctor or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
phone: +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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Sugammadex Accord

The medication will be stored by healthcare professionals.
Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton and vial after: "EXP".
The expiration date refers to the last day of the specified month.
Do not store above 25°C.
Store the vial in the outer packaging to protect from light.
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 Accord 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 (37%) (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What Sugammadex Accord looks like and contents of the pack

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

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer/Importer

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Laboratori Fundació Dau
C/ C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet: --------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:
To obtain detailed information, refer to the Summary of Product Characteristics of Sugammadex Accord.