ROCURONIUM 10 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Rocuronium Kalceks, 10 mg/ml, Solution for Injection/Infusion
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is Rocuronium Kalceks and what is it used for
4. Important information before using Rocuronium Kalceks
   1. When not to use Rocuronium Kalceks:
   2. Warnings and precautions
   3. Certain medical conditions may affect the action of Rocuronium Kalceks, such as:
   4. Children and elderly patients
   5. Rocuronium Kalceks and other medicines
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Rocuronium Kalceks contains sodium
5. How to use Rocuronium Kalceks
   1. Dosage
   2. How Rocuronium Kalceks is administered
   3. Overdose of Rocuronium Kalceks
6. Possible side effects
   1. Uncommon or rare side effects (may affect up to 1 in 100 people):
   2. Very rare side effects (may affect up to 1 in 10,000 people):
   3. Reporting side effects
7. How to store Rocuronium Kalceks
8. Contents of the package and other information
   1. What Rocuronium Kalceks contains
   2. What Rocuronium Kalceks looks like and contents of the package
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Date of last revision of the package leaflet: 07/2023

Package Leaflet: Information for the User

Rocuronium Kalceks, 10 mg/ml, Solution for Injection/Infusion

Rocuronium bromide

Read the package leaflet carefully before using the medicine, 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 anesthesiologist or another doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your anesthesiologist or doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Rocuronium Kalceks and what is it used for
• 2. Important information before using Rocuronium Kalceks
• 3. How to use Rocuronium Kalceks
• 4. Possible side effects
• 5. How to store Rocuronium Kalceks
• 6. Contents of the package and other information

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

Rocuronium Kalceks belongs to a group of medicines called muscle relaxants. Muscle relaxants are used during surgical procedures as part of general anesthesia. During the operation, the patient's muscles must be completely relaxed. This makes it easier for the surgeon to perform the operation. Rocuronium Kalceks is used in adult patients as an auxiliary medicine in general anesthesia to facilitate endotracheal intubation for artificial ventilation (mechanical breathing support). Rocuronium Kalceks may also be used in intensive care units (ICU) for short-term muscle relaxation.

2. Important information before using Rocuronium Kalceks

When not to use Rocuronium Kalceks:

• if you are allergic to rocuronium or any of the other ingredients of this medicine (listed in section 6). If the above warning applies to you, tell your anesthesiologist.

Warnings and precautions

Before starting treatment with Rocuronium Kalceks, discuss it with your anesthesiologist:

• if you are allergic to muscle relaxants,
• if you have kidney, heart, liver, or gallbladder disease,
• if you have had diseases that affect the nerves and muscles,
• if you have fluid retention (edema),
• if you have had malignant hyperthermia in the past (sudden fever with rapid heartbeat, rapid breathing, and stiffness, pain, or weakness of the muscles). Tell your anesthesiologist if you have had any of the above symptoms.

Certain medical conditions may affect the action of Rocuronium Kalceks, such as:

• low calcium levels in the blood,
• low potassium levels in the blood,
• high magnesium levels in the blood,
• low protein levels in the blood,
• excessive carbon dioxide levels in the blood (hypercapnia),
• excessive water loss from the body (caused by past illnesses, diarrhea, excessive sweating),
• excessive breathing leading to low carbon dioxide levels in the blood (alkalosis),
• poor overall health,
• burns,
• obesity,
• very low body temperature (hypothermia). If any of these situations apply to you, your anesthesiologist will take this into account when determining the appropriate dose of Rocuronium Kalceks.

Children and elderly patients

Rocuronium Kalceks can be used in children (newborns and adolescents) and elderly patients, but the doctor should first assess the patient's health.

Rocuronium Kalceks and other medicines

Tell your anesthesiologist or doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. This includes medicines or herbal products you have bought without a prescription. Rocuronium Kalceks may affect other medicines or its action may be affected by other medicines. Medicines that enhance the action of Rocuronium Kalceks:

• certain antibiotics,
• certain medicines used to treat heart disease or high blood pressure (diuretics, calcium antagonists, beta-adrenergic blockers, and quinidine),
• certain anti-inflammatory medicines (corticosteroids),
• medicines used to treat bipolar disorder,
• magnesium salts,
• certain medicines used to treat malaria.

Medicines that weaken the action of Rocuronium Kalceks:

• certain medicines used to treat epilepsy,
• calcium chloride and potassium chloride,
• certain protease inhibitors (gabexate, ulinastatin).

Additionally, during or before surgery, you may receive other medicines that may change the action of Rocuronium Kalceks. These include certain anesthetics, other muscle relaxants, such as phenytoin, and medicines that counteract the action of Rocuronium Kalceks. Rocuronium Kalceks may accelerate the action of certain anesthetics. Your anesthesiologist will take this into account when determining the appropriate dose of Rocuronium Kalceks for you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or anesthesiologist for advice before using this medicine. Pregnancy In animal studies, no adverse effects have been observed. However, clinical studies with rocuronium bromide in pregnant women have not been conducted. Therefore, caution should be exercised when using rocuronium bromide in pregnant women. Caesarean section The doctor will decide whether rocuronium bromide can be used during a Caesarean section. It has been shown that a dose of 0.6 mg/kg body weight of rocuronium bromide can be safely used during a Caesarean section and has no harmful effect on the baby. Breastfeeding You should not breastfeed for 6 hours after using this medicine.

Driving and using machines

Do not drive or operate machinery until your doctor considers it safe. Rocuronium Kalceks is part of general anesthesia, so it may cause tiredness, weakness, or dizziness for some time after use. Your anesthesiologist will inform you how long these effects may last.

Rocuronium Kalceks contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, which means it is considered "sodium-free".

3. How to use Rocuronium Kalceks

Dosage

Your anesthesiologist will determine the correct dose of Rocuronium Kalceks, taking into account:

• the type of anesthesia,
• the planned duration of the operation,
• other medicines you are taking,
• your health condition.

The usual dose is 0.6 mg/kg body weight of rocuronium bromide, which acts for 30 to 40 minutes.

How Rocuronium Kalceks is administered

Rocuronium Kalceks is administered to you by your anesthesiologist. Rocuronium Kalceks should be administered intravenously, either as a single injection or as a continuous infusion (drip).

Overdose of Rocuronium Kalceks

During surgery, your anesthesiologist constantly monitors your condition, so it is unlikely that they will give you too much Rocuronium Kalceks. However, in case of overdose, your anesthesiologist will ensure mechanical ventilation until you can breathe on your own. You may also need to stay asleep until the symptoms of overdose have resolved. If you have any further questions about the use of this medicine, ask your anesthesiologist or doctor.

4. Possible side effects

Like all medicines, Rocuronium Kalceks can cause side effects, although not everybody gets them. Side effects that occur while you are under anesthesia will be noticed and treated by your anesthesiologist.

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

• too strong or too weak action of the medicine;
• longer than expected action of the medicine;
• decreased blood pressure;
• rapid heartbeat;
• pain at the injection site.

Very rare side effects (may affect up to 1 in 10,000 people):

• allergic reactions (such as difficulty breathing, circulatory collapse, and shock);
• wheezing;
• muscle weakness;
• swelling, rash, or redness of the skin.

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

• severe allergic coronary artery spasm (Kounis syndrome) causing chest pain (angina pectoris) or heart attack (myocardial infarction);
• dilated pupils (mydriasis) or fixed pupils that do not change size in response to light or other stimuli.

If any of the side effects get serious, or if you notice any side effects not listed in this package leaflet, tell your doctor or anesthesiologist.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your anesthesiologist or 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, 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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Rocuronium Kalceks

Keep this medicine out of the sight and reach of children. Store in a refrigerator (at a temperature between 2°C and 8°C). Do not freeze. Storage outside the refrigerator: Rocuronium Kalceks can also be stored outside the refrigerator, at a temperature not exceeding 25°C, for up to 12 weeks. After this time, the medicine should be discarded. The medicine that has been stored outside the refrigerator should not be put back in the refrigerator. The storage period should not exceed the shelf life. After dilution: After dilution with infusion fluids, chemical and physical stability has been demonstrated for 72 hours at 30°C. From a microbiological point of view, the diluted medicine should be used immediately. If not used immediately, the user is responsible for the storage time and conditions of the ready-to-use solution, which should not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution has been performed in controlled and validated aseptic conditions. Do not use this medicine if you notice any particles or if the solution is not clear. Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month stated. 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 package and other information

What Rocuronium Kalceks contains

• The active substance is rocuronium bromide. 1 ml of solution contains 10 mg of rocuronium bromide. Each 5 ml vial contains 50 mg of rocuronium bromide.
• The other ingredients are: sodium chloride, sodium acetate trihydrate, glacial acetic acid (for pH adjustment), water for injections.

What Rocuronium Kalceks looks like and contents of the package

Clear, colorless or slightly yellowish solution for injection/infusion. Pack size: Rocuronium Kalceks is available in packs of 10 vials, each containing 5 ml of solution.

Marketing authorization holder and manufacturer

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

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Estonia, Czech Republic, Norway: Rocuronium bromide Kalceks, Austria: Rocuronium Kalceks 10 mg/ml Injektions-/Infusionslösung, Croatia: Rokuronijev bromid Kalceks 10 mg/ml otopina za injekciju/infuziju, France: ROCURONIUM KALCEKS 10 mg/mL, solution injectable/pour perfusion, Hungary: Rocuronium Kalceks 10 mg/ml oldatos injekció vagy infúzió, Ireland: Rocuronium bromide 10 mg/ml solution for injection/infusion, Latvia: Rocuronium bromide Kalceks 10 mg/ml šķīdums injekcijām/infūzijām, Lithuania: Rocuronium bromide Kalceks 10 mg/ml injekcinis ar infuzinis tirpalas, Netherlands: Rocuronium Kalceks 10 mg/ml oplossing voor injectie/infusie, Poland: Rocuronium Kalceks, Slovakia: Rocuronium bromide Kalceks 10 mg/ml injekčný/infúzny roztok, Slovenia: Rokuronijev bromid Kalceks 10 mg/ml raztopina za injiciranje/infundiranje, Spain: Rocuronio Kalceks 10 mg/ml solución inyectable y para perfusión EFG, United Kingdom (Northern Ireland): Rocuronium bromide 10 mg/ml solution for injection/infusion

Date of last revision of the package leaflet: 07/2023