Cisatracurium Kalceks

Package leaflet: Information for the user

Cisatracurium Kalceks 2 mg/mL injection/infusion solution

Generic medicine
Please read this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this 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 Cisatracurio Kalceks is and what it is used for

Cisatracurio Kalceks contains a medicine called cisatracurium, which belongs to a group of
medicines known as muscle relaxants.
Cisatracurio Kalceks is used:

• to relax muscles during surgical procedures, including cardiac surgery, in adults and children over 1 month of age;
• to facilitate insertion of a tube into the trachea (endotracheal intubation) when a person needs help with breathing;
• to relax muscles in adults receiving intensive care.

If you would like further explanation about this medicine, please consult your doctor.

2. What you need to know before receiving Cisatracurium Kalceks

Do not receive Cisatracurium Kalceks

• if you are allergic to cisatracurium, atracurium, or benzenesulfonic acid, or to any of the other ingredients of this medicine (listed in section 6).

If any of the above apply to you, inform your doctor or nurse before receiving Cisatracurium Kalceks.
Warnings and precautions
Talk to your doctor or nurse before receiving Cisatracurium Kalceks:

• if you have muscle weakness, fatigue, or difficulty coordinating movements (severe myasthenia gravis);
• if you have a neuromuscular disease, for example a condition causing muscle atrophy, paralysis, motor neuron disease, or cerebral palsy;
• if you have a burn requiring medical treatment;
• if you have a severe disturbance in acid-base and/or electrolyte balance;
• if you have previously had an allergic reaction to any muscle relaxant administered during surgery.

If you are unsure whether any of the above apply to you, consult your doctor or nurse before receiving Cisatracurium Kalceks.
Other medicines and Cisatracurium Kalceks
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• anaesthetics (used to reduce sensation and pain during surgical procedures);
• certain other muscle relaxants;
• antibiotics (used to treat infections);
• medicines for irregular heartbeat (antiarrhythmics);
• medicines for high blood pressure;
• diuretics such as furosemide;
• medicines for joint inflammation, such as chloroquine or D-penicillamine;
• steroids;
• medicines for seizures (epilepsy), such as phenytoin or carbamazepine;
• medicines for mental disorders, such as lithium or chlorpromazine (which may also be used for nausea);
• medicines containing magnesium;
• medicines for Alzheimer's disease (anticholinesterases, e.g. donepezil).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before receiving this medicine.
An adverse effect of cisatracurium on the breastfed infant cannot be ruled out; however, this is not expected if breastfeeding is resumed after the effects of the substance have worn off. Cisatracurium is rapidly eliminated from the body. Women should refrain from breastfeeding for 3 hours after discontinuation of treatment.
Driving and using machines
If your hospital stay is only one day, your doctor will advise you how long to wait before leaving the hospital or before driving a vehicle. It may be dangerous to drive too soon after surgery.

3. How Cisatracurium Kalceks is administered

You must never administer this medicine to yourself; it will always be given to you by a qualified person.
Cisatracurium Kalceks may be administered:

• as a single intravenous injection (intravenous bolus injection);
• as a continuous intravenous infusion. This means that the medicine is administered slowly over a prolonged period.

Your doctor will decide the method of administration and the dose. This will depend on:

• your body weight;
• the extent and duration of muscle relaxation required;
• your expected response to the medicine.

Children under 1 month of age must not receive this medicine.
If you are given more Cisatracurium Kalceks than you should
This medicine will always be administered under closely monitored conditions. However, if you think that you have been given too much, inform your doctor or nurse immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reactions (may affect up to 1 in 10,000 people)
If you have an allergic reaction, inform your doctor or nurse immediately. Signs may include:

• sudden wheezing, chest pain or tightness in the chest;
• swelling of the eyelids, face, lips, mouth or tongue;
• skin rash with lumps or hives anywhere on the body;
• collapse and shock.

Tell your doctor or nurse if you notice any of the following side effects:

Common (may affect up to 1 in 10 people)

• reduced heart rate;
• low blood pressure.

Uncommon (may affect up to 1 in 100 people)

• skin rash or redness of the skin;
• wheezing or cough.

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

• muscle weakness or muscle pain.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Cisatracurium Kalceks

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

Shelf-life after dilution
Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures of 2 − 8°C and 25°C.
From a microbiological point of view, unless the method of opening/dilution excludes the risk of microbial contamination, the medicine should be used immediately. If the medicine is not used immediately, the duration and conditions of storage during use are the responsibility of the user.

Do not use this medicine after the expiry date stated on the vial label and on the carton after "Exp". The expiry date refers to the last day of that month.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Cisatracurio Kalceks contains

• The active substance is cisatracurium (as besilate). Each mL of solution contains 2 mg of cisatracurium (as cisatracurium besilate). Each 2.5 mL vial contains 5 mg of cisatracurium. Each 5 mL vial contains 10 mg of cisatracurium. Each 10 mL vial contains 20 mg of cisatracurium.
• The other components are benzenesulfonic acid (for pH adjustment) and water for injections.

Description of the appearance of Cisatracurio Kalceks and contents of the pack
Clear, colourless or slightly yellow solution, free from visible particles.
2.5 mL, 5 mL or 10 mL solution in colourless glass vials with OPC snap-off system.
The vials are marked with a specific coloured ring code for each volume.
Five vials are packed in a PVC pouch. The pouch is placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E, Rīga, LV − 1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area countries under the following names:
Latvia Cisatracurium Kalceks 2 mg/ml solution for injection/infusion
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
Czech Republic Cisatracurium Kalceks
Denmark Cisatracurium Kalceks
Estonia Cisatracurium Kalceks
France CISATRACURIUM KALCEKS 2 mg/ml, solution injectable/pour perfusion
Germany Cisatracurium Kalceks 2 mg/ml Injektions-/Infusionslösung
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
Norway Cisatracurium Kalceks
Poland Cisatracurium Kalceks
Spain Cisatracurio Kalceks 2 mg/ml solución inyectable y para perfusión EFG

The following information is intended for healthcare professionals only:

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 not compatible with injectable ketorolac tromethamine emulsion or propofol.

Instructions for use, disposal, and handling
For single use only.
After opening the vial, the medicinal product must be used immediately.
The solution must be visually inspected before use and must not be used if any signs of deterioration are observed (e.g., particulate matter).

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

• 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

Cisatracurium has been shown to be compatible with the following commonly used perioperative medications when mixed under conditions simulating administration via a Y-site injection into an ongoing intravenous infusion: alfentanil, droperidol hydrochloride, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate.

When other medications are administered through the same needle or cannula as cisatracurium, it is recommended to clear the line by flushing with an adequate volume of a suitable intravenous solution, e.g., sodium chloride 9 mg/mL (0.9%) solution for injection.

As with other intravenously administered drugs, when a small-bore vein is selected as the injection site, cisatracurium should be flushed through the vein with an adequate volume of a suitable intravenous solution, e.g., sodium chloride 9 mg/mL (0.9%) solution for injection.

Instructions for opening the vial

1. Turn the vial with the colored tip upward. If any solution is present in the upper part of the vial, gently tap with the finger to bring all the solution to the lower part of the vial.
2. Use both hands to open the vial; holding the lower part of the vial in one hand, use the other hand to break the upper part of the vial in the direction opposite to the colored mark (see figures below).

Any unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with local regulations.