Rocuronium kalceks

Package leaflet: Information for the user

Rocuronium Kalceks, 10 mg/ml, solution for injection / for infusion
Rocuronii bromidum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your anaesthetist or another doctor.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur in the patient, including any side effects not listed in this leaflet, inform the anaesthetist or another doctor. See section 4.

Contents of the leaflet

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

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

Rocuronium Kalceks belongs to a group of medicines called muscle relaxants. Muscle relaxants are used during surgery as part of general anaesthesia. During an operation, the patient's muscles must be completely relaxed. This makes it easier for the surgeon to perform the procedure.
Rocuronium Kalceks is used in adult patients as an adjunct to general anaesthesia to facilitate tracheal intubation for mechanical ventilation (artificial respiration). 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 the patient is allergic to rocuronium or any of the other ingredients of this medicine (listed in section 6). If this warning applies to the patient, inform the anaesthetist.

Warnings and precautions
Before starting treatment with Rocuronium Kalceks, discuss the following with the
anaesthetist:

• if the patient is allergic to muscle relaxants,
• if the patient has kidney, heart, liver or gallbladder disease,
• if the patient has had neuromuscular disorders,
• if the patient has fluid retention (oedema),
• if the patient has previously experienced malignant hyperthermia (sudden fever with rapid heartbeat, rapid breathing, and muscle stiffness, pain and/or weakness). Inform the anaesthetist if the patient has ever had any of these 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 dehydration (caused by previous illnesses, diarrhoea, or excessive sweating),
• over-breathing leading to abnormally low carbon dioxide levels in the blood (alkalosis),
• general poor health,
• burns,
• obesity,
• very low body temperature (hypothermia).
  If any of these conditions apply to the patient, the anaesthetist will take them into account when determining the appropriate dose of Rocuronium Kalceks.

Children and elderly patients
Rocuronium Kalceks may be used in children (including newborns and adolescents) and elderly
patients, but the physician should first assess the patient's overall health status.
Rocuronium Kalceks and other medicines
Inform the anaesthetist or doctor about all medicines currently taken or recently used by the patient, as well as any medicines the patient plans to take. This includes also over-the-counter medicines
or herbal products the patient may have purchased without a prescription. Rocuronium Kalceks may affect other
medicines, or its action may be altered by other medicines.
Medicines that enhance the effect of Rocuronium Kalceks:

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

Medicines that reduce the effect of Rocuronium Kalceks:

• certain antiepileptic medicines,
• calcium chloride and potassium chloride,
• certain protease inhibitors (gabexate, ulinastatine).

Additionally, the patient may receive other medicines before or during surgery that may
alter the effect of Rocuronium Kalceks. These include certain anaesthetics, other muscle relaxants, phenytoin, and medicines that reverse the effect of Rocuronium
Kalceks. Rocuronium Kalceks may accelerate the action of certain anaesthetics.
The anaesthetist will take this into account when determining the appropriate dose of Rocuronium
Kalceks for the patient.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or anaesthetist before using this medicine.
Pregnancy
Animal studies have not shown any adverse effects. However, clinical studies with rocuronium bromide have not been conducted in pregnant women. Therefore, caution should be exercised when administering rocuronium bromide to pregnant women.
Caesarean section
The physician will decide whether rocuronium bromide can be used during caesarean section.
It has been demonstrated that a dose of rocuronium bromide of 0.6 mg/kg body weight can be safely
administered during caesarean section and has no harmful effect on the newborn.
Breastfeeding
Breastfeeding should be avoided for 6 hours after administration of this medicine.
Driving and operating machinery
Do not drive or operate machinery until the doctor considers it safe to do so. Rocuronium Kalceks is part of general anaesthesia and may cause fatigue, weakness, or dizziness for some time after administration. The anaesthetist will inform the patient how long these effects may last.
Rocuronium Kalceks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, meaning the medicine is considered "sodium-free".

3. How to use Rocuronium Kalceks

Dosage
The anaesthetist will determine the appropriate dose of Rocuronium Kalceks based on:

• the type of anaesthesia,
• the planned duration of surgery,
• other medications the patient is receiving,
• the patient's health status.

The usual dose is 0.6 mg/kg of rocuronium bromide, which has a duration of action of 30 to 40 minutes.

How Rocuronium Kalceks is administered
Rocuronium Kalceks is administered by the anaesthetist. It should be given intravenously, either as a single bolus injection or by continuous infusion (intravenous drip).

Overdose of Rocuronium Kalceks
During surgery, the anaesthetist continuously monitors the patient's condition, making it unlikely that an excessive dose of Rocuronium Kalceks would be administered. However, in the event of an overdose, the anaesthetist will provide mechanical ventilation until the patient is able to breathe independently. The patient may also require continued anaesthesia until the effects of the overdose subside.

If you have any further questions regarding the use of this medicine, please consult your anaesthetist or treating physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions occurring in a patient under anaesthesia will be noticed and treated by the anaesthetist.

Uncommon or rare (may occur in less than 1 in 100 patients):

• excessive or insufficient effect of the medicine;
• prolonged duration of action of the medicine;
• decreased blood pressure;
• increased heart rate;
• pain at the injection site.

Very rare (may occur in less than 1 in 10,000 patients):

• allergic reactions (i.e. breathing difficulties, circulatory collapse, and shock);
• wheezing;
• muscle weakness;
• swelling, rash, or skin redness.

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 adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your anaesthetist or doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your anaesthetist or doctor. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 of 2°C to 8°C). Do not freeze.

Storage outside the refrigerator:
Rocuronium Kalceks may also be stored outside the refrigerator at a temperature not exceeding 25°C for up to 12 weeks. After this period, the medicine must be discarded. Once removed from the refrigerator, the medicine must not be returned to it for storage. The storage period must not exceed the expiry date.

After dilution:
After dilution with infusion fluids, chemical and physical stability has been demonstrated for 72 hours at 30°C.
From a microbiological standpoint, the diluted medicine should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration of the ready-to-use solution, which must not exceed 24 hours at a temperature of 2°C to 8°C, provided that dilution was carried out under controlled and validated aseptic conditions.

Do not use this medicine if solid particles are visible or if the solution is not clear.
Do not use this medicine after the expiry date stated on the label after "EXP" and on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
• 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 pack
Clear, colourless or slightly yellow solution for injection / for infusion.
Pack size:
Rocuronium Kalceks is available in packs of 10 vials containing 5 ml of solution.
Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area countries 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