Cisatracurium kalceks

Package leaflet: Information for the user

Cisatracurium Kalceks, 2 mg/ml, solution for injection/infusion
Cisatracurium
Please read all of this leaflet carefully before this medicine is given, 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 or nurse.
­ If you get any side effects, including any not listed in this leaflet, please tell your doctor or nurse.
See section 4.

Contents of the leaflet:

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

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

Cisatracurium Kalceks contains a substance called cisatracurium. It belongs to a group of medicines known as muscle relaxants.
Cisatracurium Kalceks is used:

• to relax muscles during surgical procedures in adults and children over 1 month of age, including cardiac surgery;
• to facilitate insertion of a tube into the windpipe (endotracheal intubation) when mechanical ventilation is required;
• to relax muscles in patients in intensive care units.

For further information about this medicine, please consult your doctor.

2. Important information before using Cisatracurium Kalceks

When not to use Cisatracurium Kalceks

• if the patient is allergic to cisatracurium, atracurium, or benzenesulfonic acid (listed in section 6).

Before starting Cisatracurium Kalceks, discuss this with the doctor or nurse.
Warnings and precautions
Before starting treatment with Cisatracurium Kalceks, contact the doctor or nurse:

• if the patient has muscle weakness and fatigue or difficulty with movement coordination (myasthenia);
• if the patient has neuromuscular disorders such as muscle atrophy, paralysis, amyotrophic lateral sclerosis, or cerebral palsy;
• if the patient has burns requiring treatment;
• if the patient has severe acid-base or electrolyte imbalance;
• if the patient has ever had an allergic reaction to any muscle relaxant administered during surgery.

If in doubt whether any of the above conditions apply to the patient, contact the doctor or nurse before administering Cisatracurium Kalceks.
Cisatracurium Kalceks and other medicines
Inform the doctor about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

• anaesthetics (used to block sensation and pain during surgical procedures);
• other medicines used to relax muscles;
• antibiotics (used to treat infections);
• medicines used to treat heart rhythm disorders (antiarrhythmics);
• medicines used to treat high blood pressure;
• diuretics (water pills), such as furosemide;
• medicines used to treat inflammatory joint conditions, such as chloroquine or D-penicillamine;
• steroids;
• medicines used to treat seizures (epilepsy), such as phenytoin or carbamazepine;
• medicines used to treat psychiatric disorders, such as lithium or chlorpromazine (also used as an antiemetic);
• medicines containing magnesium;
• medicines used to treat Alzheimer's disease (acetylcholinesterase inhibitors, e.g. donepezil).

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
A harmful effect of cisatracurium on the breastfed infant cannot be excluded; however, this should not be of concern if breastfeeding is resumed after the drug's effect has worn off. Cisatracurium is rapidly eliminated from the body. Women should refrain from breastfeeding for 3 hours after completion of treatment.
Driving and operating machinery
If the patient is hospitalized for only one day, the doctor will determine how long to wait before leaving the hospital or driving. Driving too soon after surgery may be dangerous.
3. How to use Cisatracurium Kalceks
The patient must never administer this medicine himself/herself. The medicine will always be given by a qualified person.
Cisatracurium Kalceks may be administered:

• as a single intravenous injection (rapid intravenous bolus),
• as a continuous intravenous infusion. In this case, the medicine is administered slowly over a prolonged period.

The doctor will decide on the route of administration and the dose of the medicine to be given. This will depend on:

• the patient's body weight;
• the required duration and degree of muscle relaxation;
• the expected response of the patient to the medicine.

This medicine must not be used in children under 1 month of age.
Use of a higher than recommended dose of Cisatracurium Kalceks
The medicine will always be administered under medical supervision. However, if the patient believes that an excessive dose has been administered, he/she should immediately inform the doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Allergic reactions (may occur in fewer than 1 in 10,000 patients)
If an allergic reaction occurs, inform the doctor or nurse immediately. Symptoms may include:

• sudden wheezing, chest pain or tightness;
• swelling of the eyelids, face, lips, mouth or tongue;
• raised, itchy rash (hives) appearing anywhere on the body;
• collapse and shock.

If any of the following symptoms occur, inform the doctor or nurse:
Common (may affect up to 1 in 10 patients)

• slow heart rate;
• low blood pressure.

Uncommon (may affect up to 1 in 100 patients)

• skin rash or redness;
• wheezing or coughing.

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

• muscle weakness or muscle pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform the doctor or nurse. 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 Cisatracurium Kalceks

Keep this medicine out of sight and reach of children.
Store and transport under refrigerated conditions (2 °C – 8 °C). Do not freeze.
Store in the original packaging to protect from light.

Stability after dilution
Physical and chemical stability has been demonstrated for at least 24 hours after opening the ampoule, when stored at 2–8°C and 25°C.
From a microbiological point of view, if the method of opening/dilution does not exclude the risk of microbial contamination, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions.

Do not use this medicine after the expiry date stated on the ampoule label and on the outer carton after the word "EXP". The expiry date refers to the last day of the stated month.

Medicines should not be disposed of via the sewage system 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 Kalceks contains

• The active substance is cisatracurium (as besylate). Each ml of solution contains 2 mg of cisatracurium (as cisatracurium besylate). Each 2.5 ml ampoule contains 5 mg of cisatracurium. Each 5 ml ampoule contains 10 mg of cisatracurium. Each 10 ml ampoule contains 20 mg of cisatracurium.
• Other components are: benzenesulfonic acid (for pH adjustment), water for injections.

What Cisatracurium Kalceks looks like and contents of the pack
A clear, colourless or slightly yellow solution, free from visible particles.
The solution is available in 2.5 ml, 5 ml or 10 ml ampoules made of colourless Type I glass, with an OPC (scored) point.
Ampoules are marked with a coloured ring, each volume having a different colour.
Five ampoules are placed in a PVC blister and packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
1057 Rīga
Latvia

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Latvia Cisatracurium Kalceks 2 mg/ml šķīdums injekcijām/infūzijām
Austria Cisatracurium Kalceks 2 mg/ml Injektions-/Infusionslösung
Belgium Cisatracurium Kalceks 2 mg/ml, solution injectable/pour perfusion
Cisatracurium Kalceks 2 mg/ml, oplossing voor injectie/infusie
Cisatracurium Kalceks 2 mg/ml, Injektions-/Infusionslösung
Estonia Cisatracurium Kalceks
France CISATRACURIUM KALCEKS 2 mg/ml, solution injectable/pour perfusion
Hungary Cisatracurium Kalceks 2 mg/ml oldatos injekció/infúzió
Ireland Cisatracurium 2 mg/ml solution for injection/infusion
Italy Cisatracurio Kalceks
Lithuania Cisatracurium Kalceks 2 mg/ml injekcinis ar infuzinis tirpalas
Poland Cisatracurium Kalceks

Information intended exclusively for healthcare professionals:

Incompatibilities
Since cisatracurium is stable only in acidic solutions, it must not be mixed in the same syringe or administered simultaneously through the same needle with alkaline solutions (e.g., sodium thiopental). Cisatracurium is incompatible with ketorolac tromethamine or propofol emulsion for injection.

Instructions for use, disposal, and other procedures
For single use only.
The medicinal product should be used immediately after opening the ampoule.
Before administration, inspect the solution visually. The product should not be used if any signs of degradation are observed (e.g., particulate matter).

The diluted Cisatracurium Kalceks product is physically and chemically stable for 24 hours at 2–8°C and 25°C at a concentration of 0.1 mg/mL in the following infusion fluids, when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and polypropylene or PVC infusion bags:

• Sodium chloride 9 mg/mL (0.9%), solution for injection;
• Glucose 50 mg/mL (5%), solution for injection;
• Sodium chloride 1.8 mg/mL (0.18%) and glucose 40 mg/mL (4%), solution for injection;
• Sodium chloride 4.5 mg/mL (0.45%) and glucose 25 mg/mL (2.5%), solution for injection.

Under conditions simulating Y-site infusion, cisatracurium has shown no pharmaceutical incompatibilities with the following drugs commonly used in the perioperative period: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate.

If other drugs are administered through the same intravenous line or cannula used for cisatracurium, it is recommended to flush the system with an appropriate volume of a compatible infusion fluid (e.g., sodium chloride 9 mg/mL [0.9%] solution for injection) after administration of each drug.

Similarly, as with other intravenously administered drugs, if a small vein is used as the injection site, the vein should be flushed with an appropriate infusion fluid (e.g., sodium chloride 9 mg/mL [0.9%] solution for injection) following administration of Cisatracurium Kalceks.

Instructions for opening the ampoule

1. Turn the ampoule so that the coloured dot is facing upwards. If any solution remains in the upper part of the ampoule, gently tap with a finger to ensure all the solution moves to the lower part.
2. Use both hands to open: hold the lower part of the ampoule in one hand and, with the other hand, break off the top part of the ampoule in the direction away from the coloured dot (see figure below).

Any unused portions of the medicinal product or waste materials should be disposed of in accordance with local regulations.