Cisatracurium Kalceks 2 mg/ml solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

cisatracurium

Read all of 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, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

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

Cisatracurio Kalceks is used to:

• relax muscles during surgical procedures, including heart surgery, in adults and children over 1 month of age;
• facilitate the insertion of a tube into the trachea (tracheal intubation) when a person requires assistance with breathing;
• relax muscles in adults in intensive care settings.

Ask your doctor if you need further information about this medicine.

2. What you need to know before Cisatracurium Kalceks is administered to you

Do not be given Cisatracurium Kalceks

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

If any of the above apply to you, speak with your doctor or nurse before receiving this medicine.

Warnings and precautions

Talk to your doctor or nurse before receiving Cisatracurium Kalceks if:

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

If you are unsure whether any of the above apply to you, speak with your doctor or nurse before receiving this medicine.

Other medicines and Cisatracurium Kalceks

Inform your doctor if you are taking, have recently taken, or might need to take 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);
• other medicines used to relax muscles;
• antibiotics (used to treat infections);
• medicines used for heart rhythm disorders (antiarrhythmics);
• medicines used for high blood pressure;
• medicines that help remove fluids (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 health conditions, such as lithium or chlorpromazine (which may also be used to prevent vomiting);
• medicines containing magnesium;
• medicines for Alzheimer's disease (anticholinesterases such as, e.g., donepezil).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine.

An adverse effect of cisatracurium on the breastfed infant cannot be ruled out; however, no such effect is expected if breastfeeding is resumed after the effects of the substance have worn off. Cisatracurium is rapidly eliminated from the body. Women should not breastfeed for 3 hours after discontinuation of treatment.

Driving and use of machinery

If you are staying in hospital for only one day, your doctor will advise you how long to wait before leaving the hospital or driving. It may be dangerous to drive shortly after surgery.

3. How to use Cisatracurium Kalceks

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

Cisatracurium Kalceks may be administered:

• as a single intravenous injection (rapid intravenous injection or bolus);
• as a continuous intravenous infusion. This is when the medicine is given slowly over a prolonged period of time.

Your doctor will decide the method and dose of medicine you will receive. This will depend on:

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

This medicine must not be given to children under 1 month of age.

If you have been given more Cisatracurium Kalceks than you should have

This medicine will always be administered under carefully controlled conditions. However, if you think you have been given too much, inform your doctor or nurse immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

If you experience 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 or hives anywhere on the body;
• collapse and anaphylactic shock.

Talk to your doctor or nurse if you notice any of the following:

Frequent (may affect up to 1 in 10 people)

• decreased heart rate;
• drop in blood pressure.

Uncommon (may affect up to 1 in 100 people)

• skin rash or redness;
• wheezing or cough.

Very rare (affects less than 1 in 10,000 people)

• muscle weakness or pain.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cisatracurium Kalceks

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

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

Keep in the original packaging to protect from light.

Period of validity after dilution

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

From a microbiological standpoint, unless the method of opening/dilution precludes the risk of microbial contamination, the medicine should be used immediately. If not used immediately, the times and conditions of storage prior to use are the responsibility of the user.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cisatracurio Kalceks

• The active substance is cisatracurium (as besilate).

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

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.

• The other components are benzenesulfonic acid (for pH adjustment) and water for injections.

Appearance of the product and contents of the pack

Clear, colourless or slightly yellowish solution, free from visible particles.

2.5 ml, 5 ml or 10 ml solution in clear glass ampoules with a score mark.

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

AS KALCEKS
Krustpils iela 71E, Riga, LV-1057
Tel.: +371 67083320
E-mail: [email protected]
Latvia

Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder

EVER Pharma Therapeutics Spain SL
Toledo 170
28005 Madrid
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Latvia Cisatracurium Kalceks 2 mg/ml škidums injekcijam/infuzijam
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 soluci?n inyectable y para perfusión EFG

Date of the most recent revision of this leaflet: June 2021.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This 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 ketorolac tromethamine or with injectable propofol emulsion.

Instructions for use, disposal and other handling

For single use only.

The medicine should be administered immediately after opening the ampoule.

The medicine should be inspected visually before use. The medicine must not be used if there are visible signs of deterioration (e.g., particles).

Diluted Cisatracurio Kalceks 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 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%) 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 commonly used in the perioperative period when mixed under conditions simulating intravenous infusion administration via a Y-site: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate.

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

As with other intravenously administered drugs, when a small vein is used 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 coloured mark facing upwards. If any solution remains in the upper part of the ampoule, gently tap with the finger to allow all the solution to flow down to the lower part of the ampoule.
2. Use both hands to open; while holding the lower part of the ampoule with one hand, break off the upper part in the direction opposite to the coloured mark (see images below).

Disposal of unused medicine and of all materials that have been in contact with it must be carried out in accordance with local regulations.