Sugammadex accord

Package leaflet: Information for the patient

Sugammadex Accord, 100 mg/mL, solution for injection
Sugammadexum
Please read this leaflet carefully before receiving this medicine, as it contains
important information for you.
Keep this leaflet so that you can read it again if necessary.
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.

Contents of the leaflet
What Sugammadex Accord is and what it is used for
What you need to know before receiving Sugammadex Accord
How to use Sugammadex Accord
Possible side effects
How to store Sugammadex Accord
Contents of the pack and other information

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

What is Sugammadex Accord
Sugammadex Accord contains the active substance sugammadex. Sugammadex Accord is considered a
selective relaxant binding agent, because it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.

Why Sugammadex Accord is used
During certain types of surgery, the patient's muscles must be completely relaxed to allow the surgeon easier access and better operating conditions. To achieve this, 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 ventilation (artificial respiration) is required during and after surgery until the patient regains the ability to breathe independently.
Sugammadex Accord is used to accelerate the recovery of normal muscle function after surgery, enabling the patient to breathe spontaneously again more quickly.
It works by binding to rocuronium bromide or vecuronium bromide in the body.
The medicine can be used in adults when rocuronium bromide or vecuronium bromide has been administered.
It can also be used in newborns, infants, young children, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide has been given.

2. Important information before using Sugammadex Accord

When not to use Sugammadex Accord
if the patient is allergic to sugammadex or any of the other ingredients of this medicine
(listed in section 6).
In such case, inform the anaesthesiologist.
Warnings and precautions
Before starting treatment with Sugammadex Accord, discuss the following with the
anaesthesiologist:

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

Sugammadex Accord and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Sugammadex Accord may affect the action of other medicines or other medicines may affect
the action of Sugammadex Accord.
Some medicines reduce the effectiveness of Sugammadex Accord
It is especially important to inform the anaesthesiologist if the patient has recently taken
any of the following medicines:

• toremifene (used in the treatment of 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 oral contraceptives ("the pill"), vaginal contraceptive system, implant, or transdermal contraceptive system releasing progestagen (hormone-releasing intrauterine device), because it reduces the amount of hormone delivered. The amount of progestagen lost due to treatment with Sugammadex Accord is approximately equivalent to missing one oral contraceptive tablet.
If taking an oral contraceptive ("the pill") on the same day as Sugammadex Accord is administered, follow the instructions for missed dose provided in the package leaflet of the hormonal contraceptive.
If using other hormonal contraceptives (such as a vaginal contraceptive system, implant, or hormone-releasing intrauterine device), use an additional non-hormonal contraceptive method (e.g. condoms) for the next 7 days and follow the recommendations provided in the package leaflet of the respective contraceptive.
Effect on blood test results
Usually, Sugammadex Accord does not affect laboratory test results. However, it may
affect blood test results for a hormone called progesterone. Consult the doctor if progesterone levels in blood need to be tested on the same day Sugammadex Accord is administered.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the anaesthesiologist before using this medicine.
Sugammadex Accord may still be used in pregnant patients, but this should be discussed with the doctor.
It is not known whether sugammadex passes into human milk. The anaesthesiologist will help the patient decide whether to discontinue breastfeeding or to refrain from treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Accord for the mother.
Driving and operating machinery
Sugammadex Accord has no known effect on the ability to drive and operate machinery.
Sugammadex Accord contains sodium
The medicine contains up to 9.7 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Sugammadex Accord

Sugammadex Accord 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 based on:

• the patient's body weight,
• the intensity of the muscle relaxant effect in the patient.

The usual dose ranges from 2 mg/kg to 4 mg/kg body weight in patients of all ages. If rapid reversal of neuromuscular blockade is required, a dose of 16 mg/kg body weight may be administered in adults.
How Sugammadex Accord is administered
Sugammadex Accord is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
Administration of a higher than recommended dose of Sugammadex Accord
Since the anaesthesiologist closely monitors the patient's condition, overdose with Sugammadex Accord is unlikely. Nevertheless, even if such an event occurs, no problems are expected to arise.
If you have any further doubts regarding the use of this medicine, please consult the anaesthesiologist or another doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If these adverse reactions occur during anaesthesia, they will be noticed and treated by the anaesthetist.

Common adverse reactions (may occur in less than 1 in 10 people)

• Coughing
• Breathing difficulties, including coughing or movement, such as during waking up or on taking a breath.
• Light anaesthesia – the patient may start to wake up from deep sleep and therefore require more anaesthetic. This may result in movement or coughing towards the end of surgery.
• Complications during the procedure, such as changes in heart rate, coughing or movement.
• Reduced blood pressure related to the surgical procedure.

Uncommon adverse reactions (may occur in less than 1 in 100 people)

• Shortness of breath due to bronchial muscle spasm (bronchospasm) occurring 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-type 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 (frequency cannot be estimated from the available data)

• After administration of Sugammadex Accord, 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, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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 Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Sugammadex Accord

The medicine will be stored by healthcare professionals.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial following "EXP".
The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Keep the vial in the outer packaging to protect from light.
After first opening and dilution, store between 2°C and 8°C and use within 24 hours.
Medicines must not be disposed of via the sewage system 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 pack and other information

What Sugammadex Accord contains
The active substance is sugammadex.
1 mL of injection solution 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, colourless to slightly yellow injection solution.
It is available in four different pack sizes containing either 1 vial or 10 vials of 2 mL or 1 vial or 10 vials of 5 mL injection solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Tel: +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 authorised for sale in the European Economic Area under the following names:

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Product Information
of Sugammadex Accord.