Sugammadex Kalceks

Package Leaflet: Information for the User

Sugammadex Kalceks, 100 mg/mL, Solution for Injection

Sugammadex

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your anaesthesiologist or another doctor.
• If you experience any side effects, including any not listed in this package leaflet, tell your anaesthesiologist or another doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Sugammadex Kalceks and what is it used for
• 2. Important information before taking Sugammadex Kalceks
• 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 is Sugammadex Kalceks and what is it used for

What is Sugammadex Kalceks

This medicine contains the active substance sugammadex. It is considered a selective relaxant binding agent, as it only acts with certain muscle relaxants - rocuronium bromide or vecuronium bromide.

What is Sugammadex Kalceks used for

In some 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 anaesthesia. These are called muscle relaxants and include rocuronium bromide and vecuronium bromide. Since these medicines also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during and after the operation until the patient's own breathing returns. This medicine is used to speed up the recovery of muscle function after surgery, so that the patient can breathe on their own again sooner. Its action involves 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, 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 Kalceks

When not to use Sugammadex Kalceks

Warnings and precautions

Before taking Sugammadex Kalceks, discuss this with your anaesthesiologist

if the patient currently has or has had liver disease;

Children and adolescents

This medicine is not recommended for use in infants under 2 years of age.

Sugammadex Kalceks and other medicines

Tell your anaesthesiologist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Sugammadex may affect the action of other medicines, or other medicines may affect the action of sugammadex.

Some medicines reduce the effectiveness of sugammadex

It is especially important to inform your anaesthesiologist if the patient has taken the following medicines recently:

• toremifene (used to treat breast cancer).
• fusidic acid (an antibiotic).

Sugammadex may affect the effectiveness of hormonal contraceptives

This medicine 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 progestogen delivered. The amount of progestogen lost due to the use of sugammadex is roughly equivalent to missing one "pill".

Effect on laboratory tests

Usually, this medicine does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. Inform your doctor if the progesterone level in the blood should be tested on the same day that sugammadex is administered.

Pregnancy and breastfeeding

Inform your anaesthesiologist if the patient is pregnant or may be pregnant, or if the patient is breastfeeding. The patient can still be given sugammadex, but this should be discussed with the doctor first. It is not known whether sugammadex passes into breast milk. The anaesthesiologist 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 for the mother.

Driving and using machines

This medicine has no known effect on the ability to drive or use machines.

Sugammadex Kalceks contains sodium

The medicine contains up to 9.7 mg of sodium (the main component of common salt) per millilitre. This is equivalent to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Sugammadex Kalceks is given

This medicine will be given to the patient by an anaesthesiologist, or under the supervision of an anaesthesiologist.

Dose

The anaesthesiologist will adjust the dose of sugammadex based on:

• body weight;
• the dose of muscle relaxant used. The usual dose is 2-4 mg/kg body weight in adults and children and adolescents aged 2-17 years. If rapid recovery of muscle function is necessary, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Kalceks is given

This medicine is given by an anaesthesiologist. It is administered as a single injection through an intravenous line.

If more Sugammadex Kalceks is given than recommended

Since the anaesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of sugammadex will occur. However, if this happens, no problems should arise. If you have any further questions about the use of this medicine, ask your anaesthesiologist or another doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur during anaesthesia, they will be noticed and treated by the anaesthesiologist. Common side effects(may affect up to 1 in 10 people)

• cough;
• breathing difficulties, including cough or movement, such as when waking up or taking a breath;
• mild sedation - the patient may start to wake up from deep sleep and need more anaesthetic. This may cause movement or cough at the end of the operation;
• complications during the procedure, such as changes in heart rate, cough, or movement;
• decreased blood pressure related to the surgical procedure.

Uncommon side effects(may affect up to 1 in 100 people)

• shortness of breath due to bronchospasm (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, 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. Allergic reactions have been reported more frequently in healthy, conscious volunteers;
• recovery of muscle function after surgery.

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

• after administration of sugammadex, severe cases of bradycardia, as well as bradycardia, up to cardiac arrest, are possible.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your anaesthesiologist or another doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, PL-02-222 Warsaw, Tel.: +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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Kalceks

The medicine will be stored by medical personnel. Store the medicine out of 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". The expiry date refers to the last day of the month. EXP - expiry date. Lot - batch number. Do not store above 30°C. Store the vials in the outer packaging to protect from light. It has been demonstrated that the solution after opening the vial and dilution retains chemical and physical stability for 48 hours at 25°C and at a temperature of 2°C to 8°C. From a microbiological point of view, the diluted solution should be used immediately. If the solution is not used immediately, the user is responsible for the storage conditions prior to use, and the storage time should not normally exceed 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6. Contents of the pack and other information

What Sugammadex Kalceks contains

• The active substance is sugammadex. 1 mL contains sugammadex sodium equivalent to 100 mg sugammadex. Each 2 mL vial contains sugammadex sodium equivalent to 200 mg sugammadex. Each 5 mL vial contains sugammadex sodium equivalent to 500 mg sugammadex.
• The other ingredients are: sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

What Sugammadex Kalceks looks like and contents of the pack

Sugammadex Kalceks is a clear, colourless to slightly yellow solution, available in glass vials containing 2 mL or 5 mL solution. Each pack contains 1 or 10 vials. Not all pack sizes may be marketed.

Marketing authorisation holder

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

Manufacturer/Importer

AS KALCEKS, Krustpils iela 71E, LV-1057 Rīga, Latvia

This medicine is authorised in the Member States of the European Economic Area under 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

Date of last revision of the package leaflet:

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Information intended for healthcare professionals only:

To obtain detailed information, refer to the Summary of Product Characteristics of Sugammadex Kalceks.