Cisatracurium Kabi

Package Leaflet: Information for the User

Cisatracurium Kabi, 5 mg/ml, Solution for Injection/Infusion

Cisatracurium

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

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Keep this package leaflet, you may need to read it again.
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In case of any doubts, consult a doctor, nurse, or pharmacist.
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If the patient experiences any side effects, including any not listed in this package leaflet, inform the doctor, nurse, or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Cisatracurium Kabi and what is it used for

Cisatracurium Kabi belongs to a group of muscle relaxant medicines.
Cisatracurium Kabi is used:
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during various types of surgical procedures to relax muscles in adult and pediatric patients over 1 month of age;
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to facilitate the introduction of a plastic tube into the patient's trachea (tracheal intubation), if the patient requires respiratory support;
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in Intensive Care Units (ICUs) to relax muscles.

2. Important information before using Cisatracurium Kabi

When not to use Cisatracurium Kabi

• if the patient is allergicto cisatracuriumor benzenesulfonic acid.

Warnings and precautions

Before starting treatment with Cisatracurium Kabi, consult a doctor, nurse, or pharmacist:

• if the patient experiences muscle weakness, fatigue, or difficulty coordinating movements (myasthenia);
• if the patient has neuromuscular disorders, such as muscular dystrophy, paralysis, motor neuron disease, or cerebral palsy;
• if the patient has burns that require treatment;
• if the patient has severe acid-base and/or electrolyte disturbances;
• if the patient has previously experienced an allergic reaction to another muscle relaxant medicine administered during a surgical procedure.

In case of doubts about any of the above situations, inform the doctor, nurse, or pharmacist before using Cisatracurium Kabi.

Children

Cisatracurium Kabi should not be administered to children (newborns) under 1 month of age.

Cisatracurium Kabi and other medicines

Inform the doctor, nurse, or pharmacist about all medicines currently being used or recently used, as well as any planned to be used. It is especially important to inform the doctor or pharmacist about the use of the following medicines, as they may affect the action of Cisatracurium Kabi:

• anesthetic medicines (used to sedate and relieve pain during surgical procedures, such as enflurane, isoflurane, halothane, and ketamine);
• other muscle relaxant medicines, such as suxamethonium;
• antibiotics (used to treat infections, such as aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, and clindamycin);
• antiarrhythmic medicines (used to control heart rhythm, such as propranolol, oxprenolol, calcium channel blockers, lidocaine, procainamide, and quinidine);
• antihypertensive medicines, such as trimethaphan or hexamethonium;
• diuretics (such as furosemide, thiazides, mannitol, and acetazolamide);
• antirheumatic medicines, such as chloroquine or d-penicillamine;
• corticosteroids;
• medicines used to treat epilepsy, such as phenytoin or carbamazepine;
• medicines used to treat mental disorders, such as lithium salts or chlorpromazine;
• medicines containing magnesium;
• medicines used to treat Alzheimer's disease (acetylcholinesterase inhibitors, e.g., donepezil).

It may still be necessary to use Cisatracurium Kabi, and the doctor will decide what is appropriate for the patient.

Pregnancy, breastfeeding, and fertility

There is insufficient data on the use of Cisatracurium Kabi in pregnant or breastfeeding women.
It cannot be excluded that cisatracurium has a harmful effect on the breastfed child, however, it is not expected to have an effect if breastfeeding is resumed after the effect of the medicine has ceased.
Cisatracurium is rapidly eliminated from the body. The woman should not breastfeed for 3 hours after the administration of the medicine has ended.
During pregnancy, breastfeeding, or if pregnancy is suspected, or if the woman plans to have a child, consult a doctor or pharmacist before using this medicine.

Driving and using machines

Cisatracurium Kabi is used in general anesthesia. General anesthesia has a significant impact on the ability to drive vehicles and operate machines. Driving vehicles, operating machines, or working in hazardous conditions too soon after surgery may be dangerous.
The doctor will inform the patient when they can drive and operate machines again.

3. How to use Cisatracurium Kabi

How the injection is administered

Cisatracurium Kabi is administered by or under the supervision of a doctor experienced in the use of this type of medicine. The medicine will be administered to the patient always under strictly controlled conditions and in departments equipped with equipment to monitor and support the patient's circulation and breathing.

Dosage

The doctor will decide on the dose of Cisatracurium Kabi.
The dose of Cisatracurium Kabi used depends on:
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the patient's body weight;
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the required degree and duration of muscle relaxation;
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the patient's predicted response to the medicine.

Method of administration

Cisatracurium Kabi can be administered by:
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a single intravenous injection (rapid intravenous injection);
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continuous intravenous infusion (intravenous infusion or "drip"). The medicine is administered slowly into the patient's vein over a longer period.

Use of a higher than recommended dose of Cisatracurium Kabi

Cisatracurium Kabi is administered under strictly controlled conditions, so it is unlikely that the patient will receive a higher dose than recommended.
If the patient has received a higher dose than recommended or if it is suspected that they have received a higher dose than recommended, the doctor will take appropriate action.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions (may occur in less than 1 in 10,000 patients)
If an allergic reaction occurs, inform the doctor or nurse immediately.
The following symptoms may occur:
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sudden wheezing, chest pain, or feeling of tightness in the chest;
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swelling of the eyelids, face, lips, mouth, or tongue;
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hives or "nettle rash" anywhere on the body;
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anaphylactic shock and collapse.
The following side effects have been observed:

Common (may occur in less than 1 in 10 patients):

• slow heart rate;
• low blood pressure.

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

• skin rash or redness;
• bronchospasm (symptoms similar to asthma).

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

• muscle weakness or pain.

Reporting side effects

If any side effects occur, including any not listed in the package leaflet, inform the doctor, nurse, or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Cisatracurium Kabi

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month.

Storage conditions

Before opening: Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store the vial in the outer packaging to protect from light.
After opening and/or dilution:
For single use only.
Cisatracurium Kabi should be used immediately after opening the vial and/or dilution.
Any unused solution should be discarded.
Do not use this medicine if the solution is not clear and free from visible particles or if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cisatracurium Kabi contains

The active substanceis cisatracurium.
1 ml of Cisatracurium Kabi contains 5 mg of cisatracurium, in the form of 6.7 mg of cisatracurium besylate.
The other ingredientsare: benzenesulfonic acid 1% and water for injections.

What Cisatracurium Kabi looks like and contents of the pack

Cisatracurium Kabi is a clear, colorless or almost colorless to light yellow or greenish-yellow solution for injection/infusion.
Cisatracurium Kabi is available in the following pack sizes: 1 or 5 colorless glass vials containing 30 ml of solution.
Not all pack sizes may be marketed.

Marketing authorization holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer and importer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
To obtain more detailed information about this medicine, contact the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel. + 48 22 345 67 89

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium
Cisatracurium Fresenius 5 mg /ml solution for injection/infusion
Estonia
Cisatracurium Kabi 5 mg/ ml
France
Cisatracurium Kabi 5 mg/ ml, solution injectable/pour perfusion
Greece
Cisatracurium Kabi 5 mg/ ml, Διάλυμα για ένεση/έγχυση
Netherlands
Cisatracurium Fresenius Kabi 5 mg/ ml oplossing voor injectie infusie
Lithuania
Cisatracurium Kabi 5 mg/ ml injekcinis ar/infuzinis tirpalas
Latvia
Cisatracurium Kabi 5 mg/ ml šķīdums injekcijām infūzijām
Germany
Cisatracurium Kabi 5 mg/ ml Injektions-/Infusionslösung
Poland
Cisatracurium Kabi
Portugal
Cisatracúrio Kabi
Hungary
Cisatracurium Kabi 5 mg/ ml oldatos injekció vagy infúzió
United Kingdom
Cisatracurium 5 mg/ ml solution for injection /infusion

Date of last revision of the package leaflet: -------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

PREPARATION INSTRUCTIONS

Cisatracurium Kabi, 5 mg/ml, solution for injection/infusion

Read the entire information before preparing this medicine.

This is a brief information about the preparation of Cisatracurium Kabi. For full information, see the Summary of Product Characteristics.

Pharmaceutical incompatibilities

Do not mix this medicine with other medicines, except for those listed below.
Cisatracurium is only stable in acidic solutions, so it should not be mixed in the same syringe or administered through the same needle with alkaline solutions, such as thiopental sodium.
Cisatracurium Kabi is incompatible with ketorolac tromethamine or propofol emulsion for injection.

Instructions for dilution

Diluted to concentrations of 0.1 to 2 mg of cisatracurium/ml, Cisatracurium Kabi is physically and chemically stable in 9 mg/ml (0.9%) sodium chloride solution, in 9 mg/ml (0.9%) sodium chloride and 50 mg/ml (5%) glucose solution, and in 50 mg/ml (5%) glucose solution for 24 hours at 25°C.
Physical and chemical stability has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the responsibility for the storage conditions and duration of the diluted medicine before administration lies with the user. The storage time of the diluted medicine should not exceed 24 hours at 2°C - 8°C.

Dosage and administration

See: Summary of Product Characteristics.

Special precautions for disposal and preparation of the medicine for administration

Inspect the medicine before administration. Only use solutions that are clear, colorless, or almost colorless to light yellow or greenish-yellow, and free from visible particles, and when the packaging is not damaged. If the appearance of the solution has changed or the packaging is damaged, discard the medicine.
For single use only.
The medicine should be used immediately after opening the vial.
Any unused medicine or waste should be disposed of in accordance with local regulations.
Under conditions simulating infusion through a Y-connector, cisatracurium has been shown to be compatible with the following commonly used perioperative medicines: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate. If other medicines are administered through the same needle or cannula as Cisatracurium Kabi, it is recommended to flush the system with an appropriate amount of infusion solution, e.g., 9 mg/ml (0.9%) sodium chloride solution, between each medicine.