Leaflet: information for the user

Cisatracurio Kalceks 2 mg/ml injectable solution and for infusion EFG

cisatracurio

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Cisatracurio Kalceks and how is it used

2. What you need to know before you are given Cisatracurio Kalceks

3. How to use Cisatracurio Kalceks

4. Possible side effects

5. Storage of Cisatracurio Kalceks

6. Contents of the pack and additional information

Cisatracurio Kalceks contains a drug called cisatracurio. This belongs to a group of medicines known as muscle relaxants.

Cisatracurio Kalceks is used for:

• relaxing muscles during surgical operations, including heart surgery, in adults and in children over 1 month;
• facilitating the insertion of a tube into the trachea (tracheal intubation), if a person needs help breathing;
• relaxing muscles in adults in intensive care.

Ask your doctor if you need more information about this medication.

Do not administer Cisatracurio Kalceks

• if you are allergic to cisatracurio, atracurio, benzenesulfonic acid, or any of the other components of this medication (listed in section6).

If you are affected by any of the above circumstances, speak with your doctor or nurse before they administer this medication.

Warnings and precautions

Consult with your doctor or nurse before administering Cisatracurio Kalceks if:

• you have muscle weakness, fatigue, or difficulty coordinating your movements (myasthenia gravis);
• you have a neuromuscular disease that causes muscle wasting, paralysis, motor neuron disease, or cerebral palsy;
• you have burns that require medical treatment;
• you have a severe acid‑base and/or electrolyte imbalance;
• you have ever experienced an allergic reaction to any muscle relaxant administered during surgery.

If you are unsure whether you fall under any of the above circumstances, speak with your doctor or nurse before they administer this medication.

Other medications and Cisatracurio Kalceks

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Particularly, inform your doctor if you are taking any of the following medications:

• anesthetics (used to reduce sensitivity and pain during surgical interventions);
• any other muscle relaxant;
• antibiotics (used to treat infections);
• antiarrhythmic medications (used to treat irregular heart rhythms);
• medications used to treat high blood pressure;
• diuretics, such as furosemida, used to eliminate fluids;
• medications used to treat joint inflammation, such as cloroquina or D‑penicilamina;
• steroids;
• medications used to treat seizures (epilepsy), such as phenitoína or carbamazepina;
• medications used to treat mental health conditions, such as litio or clorpromazina (also used to prevent vomiting);
• medications containing magnesium;
• medications used to treat Alzheimer's disease (anticolinesterasas, such as donepezilo).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult with your doctor before they administer this medication.

Cisatracurio cannot be ruled out as a potential adverse effect in the infant; however, it is not expected to occur if breastfeeding is resumed after the effects of the substance have worn off. Cisatracurio is rapidly eliminated from the body. Women should not breastfeed for 3 hours after treatment is discontinued.

Driving and operating machinery

If you will only be in the hospital for a day, your doctor will inform you how long you should wait before leaving the hospital or driving. It may be hazardous to drive shortly after surgery.

Never attempt to administer this medication to yourself. It must always be administered by a qualified person.

Cisatracurio Kalceks may be administered:

• as a single injection into a vein (rapid intravenous injection or bolus);
• as a continuous infusion into a vein. This is when the medication is administered slowly over a long period of time.

Your doctor will decide the form and dosage of medication you will receive. This will depend on:

• your body weight;
• the amount and duration of muscle relaxation needed;
• the expected response to the medication.

This medication should not be administered to children under 1 month.

If you have received more Cisatracurio Kalceks than you should

This medication will always be administered in carefully controlled conditions. However, if you believe you have been given an excessive amount, inform your doctor or nurse immediately.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Allergic Reactions (may affect up to 1 in 10,000 people)

If you experience an allergic reaction, inform your doctor or nurse immediately. Symptoms may include:

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

Speak with your doctor or nurse if you notice any of the following:

Frequent (may affect up to 1 in 10 people)

• decreased heart rate;
• low blood pressure.

Occasional (may affect up to 1 in 100 people)

• skin rash or redness;
• wheezing or cough.

Rare (affect fewer than 1 in 10,000 people)

• muscle weakness or pain.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store and transport refrigerated (2°C – 8°C). Do not freeze.

Store in the original packaging to protect it from light.

Shelf life after dilution

Chemical and physical stability has been demonstrated in use for 24 hours at 2°C – 8°C and 25°C.

From a microbiological standpoint, unless the opening/dilution method prevents microbial contamination risk, the medication should be used immediately. If not used immediately, previous storage times and conditions before use are the responsibility of the user.

Do not use this medication after the expiration date appearing on the ampoule label and the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

Composition of Cisatracurium Kalceks

• The active principle is cisatracurium (as besilate).

Each milliliter of solution contains 2 mg of cisatracurium (as cisatracurium besilate).

Each ampoule of 2.5 ml contains 5 mg of cisatracurium.

Each ampoule of 5 ml contains 10 mg of cisatracurium.

Each ampoule of 10 ml contains 20 mg of cisatracurium.

• The other components are benzenesulfonic acid (for pH adjustment), water for injectable preparations.

Appearance of the product and contents of the package

Clear, colorless or slightly yellowish solution, without visible particles.

2.5 ml, 5 ml or 10 ml of solution in transparent glass ampoules with a cutting point.

The ampoules are marked with a ring code of a specific color for each volume.

Five ampoules are placed in a PVC tray. The tray is packaged in a cardboard box.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV 1057

Tel.: +371 67083320

E-mail:[email protected]

Latvia

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

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

LatviaCisatracurium Kalceks 2 mg/ml injection/infusion solution

AustriaCisatracurium Kalceks 2 mg/ml Injektions-/Infusionslösung

BelgiumCisatracurium 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 RepublicCisatracurium Kalceks

DenmarkCisatracurium Kalceks

EstoniaCisatracurium Kalceks

FranceCISATRACURIUM KALCEKS 2 mg/ml,solution injectable/pour perfusion

GermanyCisatracurium Kalceks 2 mg/ml Injektions-/Infusionslösung

HungaryCisatracurium Kalceks 2 mg/ml oldatos injekció/infúzió

IrelandCisatracurium 2 mg/ml solution for injection/infusion

ItalyCisatracurio Kalceks

LithuaniaCisatracurium Kalceks 2 mg/ml injekcinis ar infuzinis tirpalas

NorwayCisatracurium Kalceks

PolandCisatracurium Kalceks

SpainCisatracurio Kalceks 2 mg/ml solución inyectable y para perfusión EFG

Last review date of this leaflet: June 2021.

Further information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

Incompatibilities

Cisatracurium is only stable in acidic solutions and should not be mixed in the same syringe, or administered simultaneously using the same needle, with alkaline solutions (e.g. sodium thiopental).

Cisatracurium is not compatible with ketorolac tromethamine or propofol injectable emulsion.

Instructions for use, disposal and other manipulations

For single use.

The medicinal product must be administered immediately after opening the ampoule.

The medicinal product must be visually inspected before use. The medicinal product should not be used if it shows visible signs of deterioration (e.g. particles).

Cisatracurium Kalceks diluted is physically and chemically stable for at least 24 hours at 2-8°C and 25°C at a concentration of 0.1 mg/ml in the following infusion liquids when in contact with polypropylene or polycarbonate syringes, polyethylene or PVC tubes and polypropylene or PVC infusion bags:

• sodium chloride 9 mg/ml (0.9%) injection solution;
• glucose 50 mg/ml (5%) injection solution;
• sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) injection solution;
• sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5%) injection solution.

Cisatracurium has been shown to be compatible with the following drugs normally used in the perioperative period when mixed under conditions simulating intravenous administration through a Y-type device: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate.

When administering other drugs through the same needle or cannula as cisatracurium, it is recommended that each drug be flushed with an appropriate intravenous fluid, such as sodium chloride 9 mg/ml (0.9%) injection solution.

As with other intravenous drugs, when choosing a small vein as the injection site, cisatracurium should be flushed through the vein with an appropriate intravenous fluid, such as sodium chloride 9 mg/ml (0.9%) injection solution.

Instructions for opening the ampoule

1. Turn the ampoule with the color point upwards. If there is any solution left at the top of the ampoule, gently tap it with your finger to allow all the solution to flow to the bottom of the ampoule.
2. Use both hands to open; while holding the bottom of the ampoule with one hand, separate the top of the ampoule in the opposite direction to the color point (see the images below).

The disposal of unused medicinal product and all materials that have been in contact with it will be carried out in accordance with local regulations.