CISATRACURIUM 2 mg /Ml Solution

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Cisatracurium Kabi, 2 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 Cisatracurium Kabi and what is it used for
4. Important information before using Cisatracurium Kabi
   1. When not to use Cisatracurium Kabi
   2. Warnings and precautions
   3. Children
   4. Cisatracurium Kabi and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
5. How to use Cisatracurium Kabi
   1. How the injection is administered
   2. Dosage
   3. Method of administration
   4. Use of a higher than recommended dose of Cisatracurium Kabi
6. Possible side effects
   1. Common (may occur in less than 1 in 10 patients):
   2. Uncommon (may occur in less than 1 in 100 patients):
   3. Rare (may occur in less than 1 in 10,000 patients):
   4. Reporting side effects
7. How to store Cisatracurium Kabi
   1. Storage conditions
8. Contents of the pack and other information
   1. What Cisatracurium Kabi contains
   2. What Cisatracurium Kabi looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the package leaflet: -------------------------------------------------------------------------------------------------------------------------
   8. INSTRUCTIONS FOR PREPARATION OF THE MEDICINE
   9. Read the entire information before preparing this medicine.
   10. Incompatibilities
   11. Instructions for dilution of the medicine
   12. Dosage and method of administration
   13. Special precautions for disposal and preparation of the medicine for administration

Package Leaflet: Information for the User

Cisatracurium Kabi, 2 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 insertion of a plastic tube into the patient's airway (endotracheal 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

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if the patient is allergicto cisatracuriumor benzenesulfonic acid.

Warnings and precautions

Before starting treatment with Cisatracurium Kabi, consult a doctor, nurse, or pharmacist:
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if the patient experiences muscle weakness, fatigue, or difficulty coordinating movements (myasthenia);
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if the patient has neuromuscular disorders, such as muscular dystrophy, paralysis, motor neuron disease, or cerebral palsy;
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if the patient has burns requiring treatment;
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if the patient has severe acid-base and/or electrolyte disturbances;
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if the patient has previously experienced an allergic reaction to another muscle relaxant, administered in connection with 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 taken or recently taken, as well as any planned to be taken. It is particularly important to inform the doctor or pharmacist about the use of the following medicines, as they may affect the action of Cisatracurium Kabi:
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anesthetic medicines (used to sedate and relieve pain during surgical procedures, such as enflurane, isoflurane, halothane, and ketamine);
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other muscle relaxants, such as suxamethonium;
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antibiotics (used to treat infections, such as aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, and clindamycin);
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anti-arrhythmic medicines (used to control heart rhythm, such as propranolol, oxprenolol, calcium channel blockers, lidocaine, procainamide, and quinidine);
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antihypertensive medicines, such as trimethaphan or hexamethonium;
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diuretics (diuretic tablets, such as furosemide, thiazides, mannitol, and acetazolamide);
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anti-rheumatic medicines, such as chloroquine or d-penicillamine;
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corticosteroids;
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medicines used to treat epilepsy, such as phenytoin or carbamazepine;
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medicines used to treat mental disorders, such as lithium salts or chlorpromazine;
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medicines containing magnesium;
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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 may have 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 end of administration of the medicine.
During pregnancy, breastfeeding, or if pregnancy is suspected, or if the woman is planning 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 vehicles 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 on wards equipped with equipment allowing monitoring and support of the patient's circulation and respiration.

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 predicted response of the patient 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 of the medicine than recommended.
If the patient has received a higher dose of the medicine than recommended or if there is a suspicion that they have received a higher dose of the medicine than recommended, the doctor will take appropriate action.
In case of any further doubts related to 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):

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slowing of the heart rate;
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low blood pressure.

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

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rash or redness of the skin;
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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 Medicinal Product Monitoring, 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

Store 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 ampoules in the original packaging to protect from light.
After opening and/or dilution:
For single use only.
Cisatracurium Kabi should be used immediately after opening the ampoule and/or dilution.
Any unused solution or waste material should be disposed of.
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

Active substanceof the medicine is cisatracurium.
1 ml Cisatracurium Kabi contains 2 mg cisatracurium, in the form of 2.68 mg cisatracurium besylate.
Other ingredients are:benzenesulfonic acid 1% and water for injections.

What Cisatracurium Kabi looks like and contents of the pack

Cisatracurium Kabi is a clear, colorless to light yellow or greenish-yellow solution for injection/infusion.
Cisatracurium Kabi is available in colorless, glass ampoules containing 2.5 ml, 5 ml, or 10 ml solution.
Pack sizes:
1, 5, 10, or 50 ampoules in a pack.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany
To obtain more detailed information on 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 Kabi 2 mg/ml solution for injection/infusion
Czech Republic
Cisatracurium Kabi
Denmark
Cisatracurium Fresenius Kabi
Estonia
Cisatracurium Kabi 2 mg/ml
Finland
Cisatracurium Fresenius Kabi 2 mg/ml
France
Cisatracurium Kabi 2 mg/ml solution injectable/pour perfusion
Greece
Cisatracurium/Kabi 2mg/ml, , Διάλυμα για ένεση/έγχυση
Spain
Cisatracurio Kabi 2mg/ml solución inyectable y para perfusión EFG
Netherlands
Cisatracurium Fresenius Kabi 2 mg/ml oplossing voor injectie of infusie
Lithuania
Cisatracurium Kabi 2 mg/ml injekcinis ar/infuzinis tirpalas
Luxembourg
Cisatracurium Kabi 2 mg/ml Injektionslösung/Infusionslösung
Latvia
Cisatracurium Kabi 2mg/ml šķīdums injekcijām infūzijām
Germany
Cisatracurium Kabi 2 mg/ml Injektions-/Infusionslösung
Poland
Cisatracurium Kabi
Portugal
Besilato de Cisatracúrio Kabi
Hungary
Cisatracurium Kabi 2 mg/ml oldatos injekció vagy infúzió
United Kingdom
Cisatracurium 2 mg/ml solution for injection/infusion

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

Information intended for healthcare professionals only:

INSTRUCTIONS FOR PREPARATION OF THE MEDICINE

Cisatracurium Kabi, 2 mg/ml, solution for injection/infusion

Read the entire information before preparing this medicine.

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

Incompatibilities

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

Instructions for dilution of the medicine

Diluted to concentrations of 0.1 to 2 mg 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 of the medicine has been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the responsibility for the storage conditions and duration before administration lies with the user. The storage time of the diluted medicine should not exceed 24 hours at 2-8°C.

Dosage and method of administration

See: Summary of Product Characteristics.

Special precautions for disposal and preparation of the medicine for administration

Inspect the medicine before administration. Use only clear, colorless or almost colorless to light yellow or greenish-yellow solutions, free from visible particles, and if the packaging is not damaged. If the appearance of the solution has changed or its packaging is damaged, discard the medicine.
For single use only.
The medicine should be used immediately after opening the ampoule.
Any unused solution or waste material should be disposed of in accordance with local regulations.
In 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 a suitable amount of infusion solution, e.g., 9 mg/ml (0.9%) sodium chloride solution for injection.