Cisatracurium kabi

Package leaflet: Information for the user

Cisatracurium Kabi, 5 mg/ml, solution for injection/infusion
Cisatracurium
Please read all of this leaflet carefully before this medicine is administered, because it contains important information for you.
­ Keep this leaflet, as you may need to read it again.
­ If you have any further questions, please ask your doctor, nurse, or pharmacist.
­ If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Contents of the leaflet

1. What Cisatracurium Kabi is and what it is used for
2. What you must know before being given Cisatracurium Kabi
3. How Cisatracurium Kabi is given
4. Possible side effects
5. How to store Cisatracurium Kabi
6. Contents of the pack and other information

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

Cisatracurium Kabi belongs to a group of medicines called muscle relaxants.
Cisatracurium Kabi is used:
­ during various types of surgical procedures to relax muscles in adult patients and children over 1 month of age;
­ to facilitate insertion of a plastic tube into the patient's windpipe (endotracheal intubation) when the patient requires assisted ventilation;
­ in Intensive Care Units (ICU) to relax muscles.

2. Important information before using Cisatracurium Kabi

When not to use Cisatracurium Kabi

• if the patient is allergic to cisatracurium, atracurium, or 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 with coordination (myasthenia);
• if the patient has neuromuscular disorders such as muscular dystrophy, paralysis, motor neuron disease, or cerebral palsy;
• if the patient has burns requiring treatment;
• if the patient has severe acid-base and/or electrolyte imbalances;
• if the patient previously experienced an allergic reaction to another muscle relaxant administered during a surgical procedure.

If in doubt whether any of the above situations apply to the patient, this should be
discussed with the doctor, nurse, or pharmacist before administering Cisatracurium Kabi.
Children
Cisatracurium Kabi must not be given to children (neonates) under one month of age.
Cisatracurium Kabi and other medicines
Inform the doctor, nurse, or pharmacist about all medicines currently used,
recently used, or planned for use. 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:

• anaesthetic medicines (used to sedate and relieve pain during surgical procedures, such as enflurane, isoflurane, halothane, and ketamine);
• other muscle relaxants, 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 (water tablets, such as furosemide, thiazides, mannitol, and acetazolamide);
• antirheumatic medicines, such as chloroquine or D-penicillamine;
• steroid medicines;
• medicines used to treat epilepsy, such as phenytoin or carbamazepine;
• medicines used to treat psychiatric disorders, such as lithium salts or chlorpromazine;
• medicines containing magnesium;
• medicines used to treat Alzheimer's disease (acetylcholinesterase antagonists, e.g. donepezil).

Treatment with Cisatracurium Kabi may still be appropriate, and the doctor will decide what is suitable for the patient.
Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of Cisatracurium Kabi in pregnant or breastfeeding women.
A harmful effect of cisatracurium on a breastfed infant cannot be excluded; however, an effect is not expected if breastfeeding is resumed after the effect of the drug has worn off.
Cisatracurium is rapidly eliminated from the body. Women should not breastfeed for 3 hours after the end of administration of the medicine.
During pregnancy or breastfeeding, if pregnancy is suspected, or when planning to have a child, consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Cisatracurium Kabi is used during general anaesthesia. General anaesthesia significantly
affects the ability to drive and operate machinery. Driving, operating machinery, or working in hazardous conditions too soon after surgery may be dangerous.
The doctor will inform the patient when it is safe to resume driving and operating machinery.

3. How to use Cisatracurium Kabi

How the injection is administered
Cisatracurium Kabi is administered by, or under the supervision of, a physician experienced
in the use of this type of medication. The medicine will always be given to the patient under strictly controlled
conditions and in departments equipped with equipment enabling monitoring and support of
the patient's circulation and respiration.
Dosage
The physician will determine the dose of Cisatracurium Kabi.
The dose of Cisatracurium Kabi administered depends on:
- the patient's body weight;
- the required degree and duration of muscle relaxation;
- the anticipated response of the patient to the drug.
Method of administration
Cisatracurium Kabi may be given either as:
- a single intravenous injection (rapid intravenous bolus);
- continuous intravenous infusion (intravenous infusion or "drip"). The medicine is administered slowly into the patient's vein over a prolonged period.
Administration 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 than recommended dose.
If the patient has received a higher than recommended dose, or if there is suspicion of an overdose, the physician will take appropriate actions.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Allergic reactions (may occur in fewer than 1 in 10,000 patients)
If you experience an allergic reaction, tell your doctor or nurse immediately.
The following symptoms may occur:
­ sudden wheezing, chest pain or feeling of pressure in the chest;
­ swelling of the eyelids, face, lips, mouth or tongue;
­ raised, itchy rash (hives) anywhere on the body;
­ collapse and shock.

The following side effects have been observed:
Common (may affect up to 1 in 10 people):

• slow heart rate;
• low blood pressure.

Uncommon (may affect up to 1 in 100 people):

• skin rash or redness of the skin;
• bronchospasm (asthma-like symptoms).

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

• muscle weakness or pain.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor, nurse or pharmacist. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 helps provide more information on the safety of this medicine.

5. How to store Cisatracurium Kabi

Keep this 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 stated month.
Storage conditions
Before opening: Store in a refrigerator (2°C - 8°C).
Do not freeze.
Keep the vial in the outer packaging to protect it from light.
After opening and/or dilution:
For single use only.
Cisatracurium Kabi should be used immediately after opening the vial and/or after dilution.
Any unused portions of the solution must be discarded.
Do not use this medicine if the solution is not clear and free from visible solid particles, or if the packaging is damaged.
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 pack and other information

What Cisatracurium Kabi contains
The active substance is cisatracurium.
1 ml of Cisatracurium Kabi contains 5 mg of cisatracurium in the form of 6.7 mg of cisatracurium besilate.
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, colourless to pale yellow or greenish-yellow solution for injection/infusion.
Cisatracurium Kabi is available in the following pack sizes: 1 or 5 colourless glass vials containing 30 ml of solution each.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer and Importer
Fresenius Kabi Deutschland GmbH
Pfingstweide 53
61169 Friedberg
Germany

For further information on this medicinal product, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel. + 48 22 345 67 89

This medicinal product is authorised in the European Economic Area (EEA) Member States 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 tirpalas /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

Information intended exclusively for healthcare professionals:

INSTRUCTIONS FOR PREPARATION OF THE MEDICINAL PRODUCT
Cisatracurium Kabi, 5 mg/ml, solution for injection/infusion
Read the entire information before preparing this medicinal product.
This is a summary of the instructions for preparation of Cisatracurium Kabi. For complete information, refer to the Summary of Product Characteristics.

Pharmaceutical incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Cisatracurium is stable only in acidic solutions; therefore, it must not be mixed in the same syringe or administered through the same needle together with alkaline solutions, such as sodium thiopental.
Cisatracurium Kabi shows pharmaceutical incompatibility with ketorolac tromethamine or propofol emulsion for injection.

Instructions for dilution of the medicinal product
When diluted to concentrations between 0.1 and 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 solution has been demonstrated for 24 hours at 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration prior to administration. The storage period for the diluted product should not exceed 24 hours at 2°C–8°C.

Dosage and method of administration
See: Summary of Product Characteristics.

Special precautions for disposal and preparation of the medicinal product prior to administration
Inspect the product visually before administration. Solutions should be clear, colourless or almost colourless to pale yellow or greenish-yellow, free from visible particulate matter, and the container must be undamaged. If the appearance of the solution has changed or the container is damaged, the product must be discarded.
For single use only.
The product should be used immediately after opening the vial.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.

Under conditions simulating Y-site infusion, compatibility has been demonstrated between cisatracurium and the following medicinal products commonly used during the perioperative period: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate. If other medicinal products are administered through the same fixed needle or cannula used for Cisatracurium Kabi, it is recommended to flush the system with an appropriate volume of a compatible infusion fluid (e.g., 9 mg/ml (0.9%) sodium chloride solution) after administration of each medicinal product.