Sugammadex kalceks

Package leaflet: Information for the user

Sugammadex Kalceks, 100 mg/mL, solution for injection
Sugammadexum
Please read 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 questions, please consult your anaesthesiologist or another doctor.
• If any side effects occur in the patient, including any not listed in this leaflet, inform the anaesthesiologist or another doctor immediately. See section 4.

Leaflet contents

1. What is Sugammadex Kalceks and what is it used for
2. Important information before administration of Sugammadex Kalceks
3. How Sugammadex Kalceks is administered
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 binding agent for muscle relaxants, as it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.

What Sugammadex Kalceks 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, including rocuronium bromide and vecuronium bromide.
Since these drugs also relax the respiratory muscles, assisted breathing (mechanical ventilation) is required during and after surgery until the patient's spontaneous breathing returns.
This medicine is used to accelerate the recovery of muscle function after surgery, enabling earlier restoration of the patient's ability to breathe independently. It works by binding to rocuronium bromide or vecuronium bromide in the body. The medicine may be used in adults when either rocuronium bromide or vecuronium bromide has been administered.
It may also be used in neonates, infants, young children, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide has been given.

2. Important information before administration of Sugammadex Kalceks

When not to administer Sugammadex Kalceks

• if the patient is allergic to sugammadex or to any of the other ingredients of this medicine (listed in section 6). In such case, inform the anaesthesiologist.

Warnings and precautions
Before administration of Sugammadex Kalceks, discuss the following with the anaesthesiologist:

• if the patient currently has or has previously had kidney disease. This is important
  because sugammadex 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 (edema);
• if the patient has diseases known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medicines.

Sugammadex Kalceks 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 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 the anaesthesiologist if the following medicines have been taken recently:

• toremifene (used in the treatment of breast cancer);
• fusidic acid (an antibiotic).

Sugammadex may affect the effectiveness of hormonal contraceptives
This medicine may reduce the effectiveness of hormonal contraceptives, including oral contraceptive pills, vaginal contraceptive ring, contraceptive implant, or transdermal contraceptive system releasing progestogen (hormonal intrauterine device), because it reduces the amount of progestogen delivered. The amount of progestogen lost due to sugammadex administration is approximately equivalent to missing one oral contraceptive pill.

• When taking an oral contraceptive pill, on the same day sugammadex is administered, follow the instructions for missed pill provided in the package leaflet of the hormonal contraceptive.
• When using other hormonal contraceptives (such as vaginal contraceptive ring, implant, or hormonal intrauterine device), use an additional non-hormonal contraceptive method (e.g. condom) for the next 7 days and follow the recommendations provided in the leaflet of the respective product.

Effect on blood test results
This medicine usually does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Consult the doctor if progesterone blood levels need to be tested on the same day sugammadex is administered.

Pregnancy and breastfeeding
Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex may still be used in pregnant patients, but this should first be discussed with the doctor.
It is not known whether sugammadex passes into human breast milk. The anaesthesiologist will help the patient decide whether to discontinue breastfeeding or to refrain from sugammadex treatment, taking into account the benefits of breastfeeding for the child and the benefits of sugammadex treatment for the mother.

Driving and operating machinery
This medicine has no known effect on the ability to drive or operate machinery.

Sugammadex Kalceks contains sodium
This 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 the medicine Sugammadex Kalceks is administered

This medicine 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:

• body weight,
• the dose of the muscle relaxant used. The usual dose is 2–4 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 the medicine Sugammadex Kalceks is administered
This medicine is administered by an anaesthesiologist. It is given as a single intravenous injection through an intravenous line.
If more Sugammadex Kalceks is administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose with sugammadex 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 the anaesthesiologist or another doctor.

4. Possible adverse reactions

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

Common adverse reactions (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 may require additional anaesthetic. This may cause movement or coughing towards the end of surgery;
• Complications during the procedure, such as changes in heart rate, coughing, or movement;
• Reduced blood pressure associated with the surgical procedure.

Uncommon adverse reactions (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, awake volunteers;
• Return of muscle tone to normal state after surgery.

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

• Following administration of sugammadex, severe cases of bradycardia (slow heart rate) are possible, including slowing of the heart rate up to and including cardiac arrest.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the anaesthesiologist or another doctor immediately. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Sugammadex Kalceks

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 cardboard box and on the vial label after "EXP". The expiry date refers to the last day of the stated month.
EXP – expiry date.
Lot – batch number.
Do not store above 30°C.
Store vials in the outer packaging to protect from light.
It has been demonstrated that after opening the vial and dilution, the solution maintains its chemical and physical stability for 48 hours at 25°C and at temperatures between 2°C and 8°C.
From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should generally not exceed 24 hours at temperatures between 2°C and 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.
Medicines must 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 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.

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 of 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 medicinal product is authorised in the European Economic Area member states 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

Information intended exclusively for medical professionals:

For detailed information, please refer to the Product Characteristics of Sugammadex Kalceks.