SUGAMMADEX KALCEKS

Package leaflet: Information for the user

Sugammadex Kalceks 100 mg/mL solution for injection

sugammadex
Generic medicine
Read this leaflet carefully before you are given this medicine 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 get any side effects, talk to your anaesthetist or doctor. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

What Sugammadex Kalceks is
This medicine contains the active substance sugammadex. It is considered a Selective Binding Agent
of Neuromuscular Blocking Agents, as it selectively binds to other medicines, rocuronium bromide or
vecuronium bromide, known as neuromuscular blocking agents, which relax the muscles.

What Sugammadex Kalceks 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 neuromuscular blocking agents, 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.

This medicine is used to speed up the recovery of muscle function 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 being given Sugammadex Kalceks

Do not be given Sugammadex Kalceks

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

Warnings and precautions
Talk to your anaesthetist before being given Sugammadex Kalceks

• If you currently have or have previously had kidney disease. This is important because sugammadex is eliminated from the body through the kidneys.
• If you currently have or have previously had liver disease.
• If you have fluid retention (oedema).
• If you have disorders 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 Kalceks
Inform your anaesthetist if you are taking, have recently taken, or might take any other
medicines. Sugammadex may affect or be affected by other medicines.
Some medicines reduce the effect of sugammadex
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 may affect hormonal contraceptives
This medicine may reduce the effectiveness of hormonal contraceptives (including oral contraceptive pills, vaginal ring, implant, or hormonal intrauterine system (IUS)), as it reduces the amount of progestogenic hormone absorbed. The amount of progestogen lost when taking sugammadex is approximately equivalent to missing one dose of the oral contraceptive pill.

• If you need to take an oral contraceptive pill on the same day that sugammadex is administered, follow the instructions in the contraceptive 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 provided in the product leaflet.

Effects on blood test results
In general, this medicine does not affect blood test results. However, it may interfere with test results measuring blood levels of a hormone called progesterone.
Please consult your doctor if progesterone levels need to be tested on the same day you receive sugammadex.
Pregnancy and breastfeeding
Inform your anaesthetist if you are pregnant, think you might be pregnant, or if you are breastfeeding. You may still receive sugammadex, but this should be discussed with your doctor first.
It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to stop breastfeeding or to forego treatment with sugammadex, taking into account the benefits of breastfeeding for the infant and the benefits of sugammadex for the mother.
Driving and using machines
This medicine has no known influence on the ability to drive vehicles or operate machinery.
Sugammadex Kalceks contains sodium
This medicine contains up to 9.7 mg of sodium (a main component of table salt) per mL. This is equivalent to 0.5% of the maximum daily recommended dietary intake for an adult.

3. How Sugammadex Kalceks is administered

This medicine will be administered to you by an anaesthetist or under the supervision of an anaesthetist.
The dose
The anaesthetist will determine the appropriate dose of sugammadex 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 in adults and in children and adolescents aged between 2 and 17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.

How Sugammadex Kalceks is administered
This medicine will be administered to you by the anaesthetist. It is given as a single intravenous injection.
If you are given more Sugammadex Kalceks than recommended
Since your condition will be closely monitored by the anaesthetist, it is unlikely that you will receive an excessive amount of sugammadex. 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 can cause side effects, although not everyone experiences them.
If these side effects occur during anaesthesia, they will be detected and treated by the anaesthesiologist.

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 begin to come out of deep sleep and may therefore require 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
• Decrease in 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 of 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 more commonly reported in healthy, awake volunteers
• Return of muscle relaxation after surgery

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

• When sugammadex is administered, severe slowing of the heart and slowing of the heart to the point of cardiac arrest may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to your anaesthetist or doctor. You can also report side effects directly via the national reporting system at: 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 Kalceks

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 on the label of the
vial after “Exp.” or “EXP”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep the vials in the outer packaging to protect the medicine from light.
After first opening and dilution, chemical and physical in-use stability has been demonstrated for
48 hours at a temperature of 25 °C and at 2-8 °C.
From a microbiological standpoint, the diluted medicine should be used immediately. If not used
immediately, the storage-in-use times and conditions prior to use are the responsibility of the user and
normally should not exceed 24 hours at 2-8 °C, unless the dilution was carried out under controlled and
validated aseptic conditions.

6. Package contents and other information

What Sugammadex Kalceks contains

• The active substance is sugammadex. 1 mL 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 sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

Description of the appearance of Sugammadex Kalceks and contents of the pack
Sugammadex Kalceks is a clear, colourless to pale yellow solution available in glass vials containing 2 mL or 5 mL of solution. Each pack contains 1 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries with the following names:
Denmark Sugammadex Kalceks
Austria, Germany Sugammadex Kalceks 100 mg/mL Injektionslösung
Czech Republic, Estonia,
Finland, Italy, Norway,
Poland, Sweden Sugammadex Kalceks
Belgium Sugammadex Kalceks 100 mg/mL oplossing voor injectie
Sugammadex Kalceks 100 mg/mL solution injectable
Sugammadex Kalceks 100 mg/mL Injektionslösung
Croatia Sugamadeks Kalceks 100 mg/mL otopina za injekciju
France SUGAMMADEX KALCEKS 100 mg/mL, solution injectable
Hungary Sugammadex Kalceks 100 mg/mL oldatos injekció
Ireland Sugammadex 100 mg/mL solution for injection
Latvia Sugammadex Kalceks 100 mg/mL šķīdums injekcijām
Lithuania Sugammadex Kalceks 100 mg/mL injekcinis tirpalas
Netherlands Sugammadex Kalceks 100 mg/mL oplossing voor injectie
Portugal Sugamadex Kalceks
Romania Sugammadex Kalceks 100 mg/mL soluţie injectabilă
Slovenia Sugamadeks Kalceks 100 mg/mL raztopina za injiciranje
Slovakia Sugammadex Kalceks 100 mg/mL injekčný roztok
Spain Sugammadex Kalceks 100 mg/mL soluciόn inyectable EFG

The following information is intended for healthcare professionals only:
For detailed information, please refer to the product characteristics summary of Sugammadex Kalceks.