Patient Information Leaflet

Sugammadex Zentiva, 100 mg/mL, solution for injection
Sugammadexum
Please read all of 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 adverse reactions not listed in this leaflet, inform your anaesthesiologist or another doctor immediately. See section 4.

Leaflet Contents

What Sugammadex Zentiva is and what it is used for
Important information before receiving Sugammadex Zentiva
How Sugammadex Zentiva is administered
Possible side effects
How to store Sugammadex Zentiva
Contents of the pack and other information

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

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

What Sugammadex Zentiva is used for
During certain types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the procedure more easily. For this purpose, muscle-relaxing drugs 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 Zentiva is used to accelerate the return of normal muscle function after surgery, enabling the patient to breathe independently again sooner. 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 Zentiva

When not to use Sugammadex Zentiva:

if the patient is allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

In such a case, inform the anaesthesiologist.
Warnings and precautions
Before administering Sugammadex Zentiva, discuss the following with the anaesthesiologist:

if the patient has or has had kidney disease in the past. This is important because Sugammadex Zentiva 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 (oedema).
if the patient has conditions known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medicines.

Children and adolescents
Use of this medicine is not recommended in infants under 2 years of age.
Sugammadex Zentiva and other medicines
Inform the anaesthesiologist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Sugammadex Zentiva may affect the action of other medicines or other medicines may affect the action of Sugammadex Zentiva.
Some medicines reduce the effectiveness of Sugammadex Zentiva
It is particularly 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 Zentiva may affect the effectiveness of hormonal
contraceptives
Sugammadex Zentiva may reduce the effectiveness of hormonal contraceptives, including oral contraceptives ("the pill"), vaginal contraceptive systems, implants, or transdermal contraceptive systems releasing progestogen (hormone-releasing intrauterine device), as it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex Zentiva is approximately equivalent to missing one oral contraceptive tablet.

If taking an oral contraceptive ("the pill") on the same day Sugammadex Zentiva is administered, follow the instructions provided in the package leaflet of the hormonal contraceptive regarding missed tablets.
For other hormonal contraceptives (such as vaginal contraceptive systems, implants, or hormone-releasing intrauterine devices), an additional non-hormonal contraceptive method (e.g. condoms) should be used for the next 7 days, and the recommendations in the product leaflet of the specific contraceptive should be followed.

Effect on blood test results
Sugammadex Zentiva usually does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Consult a doctor if progesterone blood levels need to be tested on the same day Sugammadex Zentiva is administered.
Pregnancy, breastfeeding and fertility
Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Zentiva 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 Zentiva for the mother.
Driving and operating machinery
Sugammadex Zentiva has no known influence on the ability to drive or operate machinery.
Sugammadex Zentiva contains sodium
The medicine contains 9.7 mg of sodium (the main component of table/food salt) in each millilitre of injection solution.
Dose less than or equal to 2.4 mL
The medicine contains less than 1 mmol (23 mg) of sodium per 2.4 mL (or smaller) dose, meaning the medicine is considered "sodium-free".
Dose greater than 2.4 mL
The medicine contains 23 mg (or more) of sodium (main component of table salt) in a 2.4 mL (or larger) dose. This corresponds to 1.15% (or more) of the maximum recommended daily dietary sodium intake for adults.

3. How is Sugammadex Zentiva administered

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

body weight
the dose of the muscle relaxant used.

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 used in adults.
How Sugammadex Zentiva is administered
Sugammadex Zentiva is administered by the anaesthetist as a single intravenous injection through an intravenous line.
If more Sugammadex Zentiva is administered than recommended
Since the anaesthetist closely monitors the patient's condition, overdose of Sugammadex Zentiva is unlikely. Nevertheless, if such an event occurs, no problems are expected to arise.
If you have any further questions regarding the use of this medicine, please consult your anaesthetist or another doctor.

4. Possible adverse effects

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

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

Coughing
Breathing difficulties, including coughing or movement, such as during awakening or taking a breath
Light anaesthesia – the patient may begin to wake up from deep sleep and require additional anaesthetic medication. This may cause movement or coughing towards the end of surgery
Complications during the procedure, such as changes in heart rate, coughing or movement
Decreased blood pressure associated with the surgical procedure

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

Shortness of breath due to bronchial muscle spasm (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, 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, conscious volunteers
Return of muscle weakness after surgery

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

Following administration of Sugammadex Zentiva, severe cases of bradycardia (slow heart rate) are possible, including bradycardia progressing to cardiac arrest

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Sugammadex Zentiva

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 label following:
"EXP". The expiry date refers to the last day of the stated month.
This medicine does not require any special temperature storage conditions.
Store vials 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 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 Zentiva contains

The active substance is sugammadex. 1 mL of the injection solution contains sodium sugammadex equivalent to 100 mg of sugammadex.

Each 2 mL vial contains sodium sugammadex equivalent to 200 mg of sugammadex.
Each 5 mL vial contains sodium sugammadex equivalent to 500 mg of sugammadex.

The other ingredients are: water for injections, hydrochloric acid (for pH adjustment) and (or) sodium hydroxide (for pH adjustment).

What Sugammadex Zentiva looks like and contents of the pack
Sugammadex Zentiva is a clear, colourless to slightly yellowish-brown solution for injection, practically free from particulate matter.
It is available in two different pack sizes, containing either 10 vials of 2 mL or 10 vials of 5 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing authorisation holder
Zentiva, k.s.,
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer
Synthon Hispania S.L.
Calle de Castello 1, Poligono Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

This medicinal product is authorised for sale in the European Economic Area under the following names:
France SUGAMMADEX ZENTIVA 100 mg/ml, solution for injection
Netherlands Sugammadex Zentiva 100 mg/mL, solution for injection
Germany Sugammadex Zentiva 100 mg/ml injection solution
Portugal Sugammadex Zentiva 100 mg/mL
Poland, Italy, Sweden, Czech Republic Sugammadex Zentiva

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

Date of last revision: July 2025