CISATRACURIO KALCEKS 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Cisatracurio Kalceks 2 mg/ml Solution for Injection and Infusion EFG

cisatracurio

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Cisatracurio Kalceks contains a medicine called cisatracurio. This belongs to a group of medicines called muscle relaxants.

Cisatracurio Kalceks is used to:

• relax muscles during surgical operations, including heart surgery, in adults and children over 1 month;
• help put a tube into the windpipe (tracheal intubation), if a person needs help with breathing;
• relax muscles in adults in intensive care.

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

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

You should not be given Cisatracurio Kalceks

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

If you are affected by any of these conditions, talk to your doctor or nurse before you are given this medicine.

Warnings and precautions

Talk to your doctor or nurse before you are given Cisatracurio Kalceks if:

• you have muscle weakness, tiredness 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 need medical treatment;
• you have a severe acid-base and/or electrolyte imbalance;
• you have ever had an allergic reaction to any muscle relaxant that you have been given during an operation.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before you are given this medicine.

Other medicines and Cisatracurio Kalceks

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

• anaesthetics (used to reduce sensitivity and pain during surgical procedures);
• any other medicine to relax muscles;
• antibiotics (used to treat infections);
• medicines used to treat heart rhythm disorders (antiarrhythmics);
• medicines used to treat high blood pressure;
• medicines that help remove fluids (diuretics), such as furosemide;
• medicines for joint inflammation, such as chloroquine or D-penicillamine;
• corticosteroids;
• medicines for seizures (epilepsy), such as phenytoin or carbamazepine;
• medicines for mental illnesses, such as lithium or chlorpromazine (which can also be used to prevent vomiting);
• medicines that contain magnesium;
• medicines for Alzheimer's disease (anticholinesterases such as donepezil).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

An adverse effect of cisatracurio on the breast-fed baby cannot be excluded; however, it is unlikely to occur if breast-feeding is resumed after the effects of the substance have disappeared. Cisatracurio is rapidly eliminated from the body. Women should not breast-feed for 3 hours after the end of treatment.

Driving and using machines

If you are going to be in hospital for just one day, your doctor will tell you how long to wait before you can leave hospital or drive. It may be dangerous to drive soon after being operated on.

3. How to use Cisatracurio Kalceks

Never try to give yourself this medicine. It should always be given by a person who is qualified to do so.

Cisatracurio Kalceks can be given:

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

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

• your body weight;
• the amount and duration of muscle relaxation needed;
• the response that you are expected to have to the medicine.

This medicine should not be given to children under 1 month.

If you have been given too much Cisatracurio Kalceks

This medicine will always be given under carefully controlled conditions. However, if you think that you have been given too much, tell 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, tell your doctor or nurse immediately. The signs may include:

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

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

Common (may affect up to 1 in 10 people)

• decrease in heart rate;
• decrease in blood pressure.

Uncommon (may affect up to 1 in 100 people)

• skin rash or redness;
• wheezing or coughing.

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

• muscle weakness or pain.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cisatracurio Kalceks

Keep this medicine 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 from light.

Shelf life after dilution

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

From a microbiological point of view, unless the method of opening/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

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

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

6. Contents of the pack and other information

Composition of Cisatracurio Kalceks

• The active substance is cisatracurio (as besylate).

Each ml of solution contains 2 mg of cisatracurio (as cisatracurio besylate).

Each 2.5 ml ampoule contains 5 mg of cisatracurio.

Each 5 ml ampoule contains 10 mg of cisatracurio.

Each 10 ml ampoule contains 20 mg of cisatracurio.

• The other ingredients are benzenesulfonic acid (for pH adjustment), water for injections.

Appearance and packaging

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

2.5 ml, 5 ml or 10 ml of solution in transparent glass ampoules with a coloured ring code for each volume.

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057

Phone: +371 67083320

Email: [email protected]

Latvia

For further information about this medicine, please contact the local representative of the marketing authorisation holder

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

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

Latvia Cisatracurium Kalceks 2 mg/ml šķīstums injekcijām/infūzijai

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

Date of last revision of this leaflet: June 2021.

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

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This information is intended only for healthcare professionals:

Incompatibilities

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

Cisatracurio is not compatible with ketorolac tromethamine or propofol injectable 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 should not be used if it shows signs of deterioration (e.g. particles).

Cisatracurio 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 solutions 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.

Cisatracurio has been shown to be compatible with the following drugs commonly used in the perioperative period when mixed under conditions simulating intravenous infusion via a Y-connector: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate.

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

As with other intravenously administered drugs, when a small vein is chosen as the injection site, cisatracurio should be flushed through the vein with a suitable 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 dot upwards. If some solution remains in the top part of the ampoule, gently tap with your finger to make the solution flow down to the bottom part of the ampoule.
2. Use both hands to open; while holding the bottom part of the ampoule with one hand, break off the top part of the ampoule in the direction away from the coloured dot (see the images below).

Disposal of the unused medicine and all materials that have been in contact with it will be done in accordance with local regulations.