SUGAMMADEX ZENTIVA

Package leaflet: Information for the user

Sugammadex Zentiva 100 mg/mL solution for injection

Equivalent medicinal product
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, tell your anaesthetist or doctor. See section 4.

Contents of this leaflet

1. What Sugammadex Zentiva is and what it is used for
2. What you need to know before Sugammadex Zentiva is administered
3. How Sugammadex Zentiva is administered
4. Possible side effects
5. How to store Sugammadex Zentiva
6. Contents of the pack and other information

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

Sugammadex Zentiva contains the active substance sugammadex. Sugammadex Zentiva is considered a Selective Relaxant Binding Agent because it selectively binds to other medicines, rocuronium bromide or vecuronium bromide, known as muscle relaxants, which relax the muscles.
What Sugammadex Zentiva is used for
During certain types of surgery, muscles need to be completely relaxed. This makes the surgeon's task easier. For this purpose, muscle-relaxing medicines are added to the general anaesthesia administered. These medicines are called muscle relaxants, and include rocuronium bromide and vecuronium bromide. Since these medicines also relax the muscles controlling 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 Zentiva 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 between 2 and 17 years) when rocuronium bromide is used for moderate levels of muscle relaxation.

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

Do not receive Sugammadex Zentiva

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

Warnings and precautions
Inform your anaesthetist before Sugammadex Zentiva is administered

• If you have or have previously had kidney disease. This is important because Sugammadex Zentiva 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 conditions known to increase the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant therapy.

Children and adolescents
This medicine is not recommended for children under 2 years of age.
Other medicines and Sugammadex Zentiva
Inform your anaesthetist if you are taking, have recently taken, or might take any other medicines. Sugammadex Zentiva may affect or be affected by other medicines.
Some medicines reduce the effect of Sugammadex Zentiva
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 Zentiva may affect hormonal contraceptives
Sugammadex Zentiva may reduce the effectiveness of hormonal contraceptives (including oral contraceptive pill, vaginal ring, implant, or hormonal intrauterine system (IUS)), as it reduces the amount of progestogenic hormone absorbed. The amount of progestogen lost when receiving Sugammadex Zentiva is approximately equivalent to missing one dose of the oral contraceptive pill.

• If you need to take the oral contraceptive pill on the same day Sugammadex Zentiva is administered, follow the instructions in the pill’s package leaflet regarding a missed dose.
• If you are using other hormonal contraceptives (e.g. a vaginal ring, implant, or IUS), you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the instructions in the package leaflet.

Effects on blood test results
Generally, Sugammadex Zentiva has no effect on blood test results. However, it may interfere with the results of a test measuring blood levels of a hormone called progesterone. Consult your doctor if testing for progesterone levels is required on the same day you receive Sugammadex Zentiva.
Pregnancy and breastfeeding
Inform your anaesthetist if you are pregnant, could be pregnant, or are breastfeeding. You may still receive Sugammadex Zentiva, but this should first be discussed with your doctor.
It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to discontinue breastfeeding or to refrain from sugammadex therapy, taking into account the benefits of breastfeeding for the child and the benefits of Sugammadex Zentiva for the mother.
Driving and using machines
Sugammadex Zentiva has no known influence on the ability to drive or operate machinery.
Sugammadex Zentiva contains sodium
This medicine contains up to 9.7 mg of sodium (a key component of table salt) per mL.
Dose less than or equal to 2.4 mL
A dose of 2.4 mL (or less) contains less than 1 mmol (23 mg) of sodium, i.e. is essentially ‘sodium-free’.
Dose greater than 2.4 mL
A dose of 2.4 mL (or more) contains 1 mmol (or more) (23 mg) of sodium. This is equivalent to 1.15% of the maximum daily sodium intake recommended in an adult diet.
Inform your anaesthetist if you are on a low-salt diet.

3. How Sugammadex Zentiva is administered

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

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

The usual dose is 2–4 mg per kg of body weight. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required. The dose of Sugammadex Zentiva in children is 2 mg/kg (in children and adolescents aged between 2 and 17 years).

How Sugammadex Zentiva is administered
Sugammadex Zentiva will be administered by the anaesthetist as a single intravenous injection.
If you are given more Sugammadex Zentiva than you should have been
Since your condition will be closely monitored by the anaesthetist, it is unlikely that you will receive an excessive amount of Sugammadex Zentiva. 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 may cause side effects, although not everyone 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 start to come out of deep sleep, thus requiring additional anaesthetic. This could cause the patient to move or cough at the end of surgery
• Complications during the procedure such as changes in heart rate, coughing, or movements
• Decreased 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 muscle contractions in the airways (bronchospasm) has been observed.

• Allergic reactions (hypersensitivity to the medicine), such as skin rash, flushed skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, which sometimes may lead to severe drops in blood pressure. Severe allergic or anaphylactoid reactions can be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers.

• Return of muscle relaxation after surgery.

Frequency not known (frequency cannot be estimated from the available data):
When Sugammadex Zentiva is administered, severe slowing of the heart rate and slowing of the heart rate up to cardiac arrest may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your anaesthetist or doctor. You can also report side effects directly via the website: 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 Zentiva

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 and label after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require special temperature precautions for storage. Keep the vial in the carton to protect the medicine from light.
After first opening and dilution, store at 2-8°C and use within 24 hours.

6. Package contents and other information

What Sugammadex Zentiva contains

• The active substance is sugammadex. 1 mL of injectable 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 components are water for injectable preparations, hydrochloric acid (to adjust pH) and/or sodium hydroxide (to adjust pH).

Description of the appearance of Sugammadex Zentiva and contents of the package
Sugammadex Zentiva is a clear, injectable solution ranging from colourless to light yellow-brown.
It is available in two different pack sizes, containing either 10 vials with 2 mL of injectable solution or 10 vials with 5 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia Srl
Viale Bodio 37/b
20158 Milano
Italy

Manufacturer
Synthon Hispania S.L.,
C/ Castelló n. 1, 08830
Saint Boi de Llobregat,
Barcelona, Spain
Synthon BV,
Microweg 22,
Nijmegen, 6545 CM
Gelderland,
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Sugammadex Zentiva 100 mg/mL, oplossing voor injectie
Czech Republic, Italy, Poland and Sweden: Sugammadex Zentiva
Germany: Sugammadex Zentiva 100 mg/ml Injektionslösung
France: SUGAMMADEX ZENTIVA 100 mg/ml, solution injectable
Portugal: Sugamadex Zentiva 100 mg/ml
Slovak Republic: Sugammadex Zentiva 100 mg/ml injekčný roztok

The following information is intended for healthcare professionals only:

For further information, refer to the Summary of Product Characteristics of
Sugammadex Zentiva