Prospecto: Information for the User

Cisatracurium Injection and Infusion Solution 2 mg/ml EFG

Read this prospect carefully before starting to use this medication because it contains important information for you.

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

Cisatracurio Sala contains an active ingredient called cisatracurio, which belongs to a group of medications known as muscle relaxants.

Cisatracurio Sala is used:

• to relax muscles during surgical operations, including cardiac surgery, in both adults and children over 1 month of age.
• to facilitate the insertion of a tube into the trachea (tracheal intubation), if mechanical assistance for breathing is required.
• to relax muscles in adults in Intensive Care.

Do not use Cisatracurio Sala:

• if you are allergic to cisatracurio, any other muscle relaxant, or any of the other components of Cisatracurio (listed in section 6)
• if you have had an allergic reaction to an anesthetic in the past

Do not use Cisatracurio if you are affected by any of the above circumstances. If you are unsure, speak with your doctor, nurse, or pharmacist before using Cisatracurio.

Warnings and precautions

Consult your doctor, nurse, or pharmacist before using this medication:

• if you have muscle weakness, fatigue, or difficulty coordinating your movements (myasthenia gravis)
• if you have a neuromuscular disease that causes muscle wasting, paralysis, motor neuron disease, or cerebral palsy
• if you have had burns that required medical attention

If you are unsure whether any of the above circumstances affect you, speak with your doctor, nurse, or pharmacist before Cisatracurio Sala is administered to you.

Other medications and Cisatracurio Sala

Inform your doctor if you are using, have recently used, or may need to use any other medication, including those purchased without a prescription. This includes herbal products or medications purchased without a doctor's prescription.

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

• anesthetics (used to reduce sensitivity or pain during a surgical procedure)
• antibiotics (used to treat infections)
• medications used to treat irregular heart rhythms (anti-arrhythmics)
• medications used to treat high blood pressure (hypertension)
• diuretics, such as furosemide, to help lose fluids
• medications for joint inflammation, such as chloroquine or D-penicillamine
• steroids
• medications for seizures (epilepsy), such as phenytoin or carbamazepine
• psychiatric medications, such as lithium, or chlorpromazine (which may also be used to prevent vomiting)
• medications containing magnesium (such as those used to treat indigestion or heartburn)
• cholinesterase inhibitors used to treat Alzheimer's disease, such as donepezil

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Cisatracurio cannot be ruled out as a potential adverse effect on 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 are to be hospitalized for only one day, your doctor will inform you how long you should wait before being able to drive and operate machinery. It may be hazardous to drive shortly after surgery.

How the injection is administered

Under no circumstances should you attempt to administer this medication yourself. It should always be administered by a qualified person.

Cisatracurio Sala can be administered:

• as a single injection into a vein (intravenous bolus injection)
• 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 on the dose and duration of treatment that they consider suitable for your procedure.

This will depend on:

• body weight
• the amount and duration of muscle relaxation desired
• the expected response of the patient to the medication.

This medication is not recommended for use in children under 1 month of age.

Ifyou receivemore Cisatracurio Sala than you should

Cisatracurio Sala will always be administered under adequately controlled conditions. However, if you think you have been given more medication than you should have, inform your doctor or nurse immediately.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

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

Inform your doctor of any adverse effect. This includes any possible adverse effect not mentioned in this prospectus.

Allergic Reactions (affect less than 1 in 10,000 people treated)

Inform your doctor or nurse immediately if you have experienced an allergic reaction. Symptoms may include:

• sudden wheezing, chest pain or pressure in the chest
• inflammation of the eyelids, face, lips, mouth, and tongue
• skin rash or urticarial hives anywhere on the body
• collapse and anaphylactic shock.

Consult with your doctor, nurse, or pharmacist if you notice any of the following:

Frequent Adverse Effects (affect between 1 and 10 in 100 people treated)

• slowing of heart rate
• drop in blood pressure (hypotension).

Less Frequent Adverse Effects (affect between 1 and 10 in 1,000 people treated)

• eruption, redness of the skin
• wheezing or cough.

Very Rare Adverse Effects (affect less than 1 in 10,000 patients treated)

• weakness or muscle pain

Reporting Adverse Effects

Ifyou experience any typeof adverse effect,consult with your doctor, pharmacist, or nurse, even if it is a possibleadverse effect notlisted in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not use this medication if you observe visible signs of deterioration in the appearance of the solution.

Cisatracurio Injection remains stable for 21 days at 25°C. Store in the refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

If diluted, store the infusion solution between 2°C and 8°C and use within 24 hours. Any remaining infusion solution not used should be discarded 24 hours after preparation.

Medications should not be disposed of through drains or in the trash. Your doctor or nurse will dispose of any medication that is no longer needed. This will help protect the environment.

Cisatracurium Besylate Composition

• The active principle is cisatracurium (as besylate).
• The other components are: benzenesulfonic acid and water for injectable preparations.

Appearance of the product and contents of the container

Cisatracurium Besylate 2 mg/ml injectable solution and for infusion EFG is presented in:

• Transparent glass vials of 2.5 ml in boxes of 5 (each vial of 2.5 ml contains 5 mg of cisatracurium).
• Transparent glass vials of 5 ml in boxes of 5 (each vial of 5 ml contains 10 mg of cisatracurium).
• Transparent glass vials of 10 ml in boxes of 5 (each vial of 10 ml contains 20 mg of cisatracurium).

Only some sizes of containers may be commercially available.

Marketing authorization holder and manufacturer responsible:

Laboratorio Reig Jofré, S.A

Gran Capitán, 10

08970 Sant Joan Despí, Barcelona

Spain

Last revision date of this leaflet:June2020

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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This information is intended solely for healthcare professionals:

This product is for single use only. Use only clear and almost colorless or slightly yellowish/greenish solutions. The product must be visually inspected before use, and if the visual appearance has changed or the container is damaged, the product must be discarded.

Cisatracurium Besylate diluted remains physically and chemically stable for at least 24 hours at 5°C and 25°C at concentrations between 0.1 and 2 mg/ml in the following infusion fluids, either in PVC or polypropylene containers.

Intravenous infusion of sodium chloride (0.9% w/v).

Intravenous infusion of glucose (5% w/v).

Intravenous infusion of sodium chloride (0.18% w/v) and glucose (4% w/v).

Intravenous infusion of sodium chloride (0.45% w/v) and glucose (2.5% w/v).

In any case, since the product does not contain antimicrobial preservatives, the dilution must be made immediately before use or, if this is not possible, it can be stored at 2-8°C for no more than 24 hours.

Cisatracurium Besylate has been shown to be compatible with the following drugs normally used in surgical operations, when mixed under conditions that simulate intravenous administration through a "Y" device: hydrochloride of alfentanil, droperidol, citrate of fentanil, hydrochloride of midazolam and citrate of sufentanil. When other drugs are administered through the same needle or cannula as Cisatracurium Besylate, it is recommended that each drug be pushed with an adequate volume of an appropriate intravenous fluid, such as: intravenous infusion of sodium chloride (0.9% w/v).

As with other intravenous drugs, when a small vein is chosen as the site of injection, Cisatracurium Besylate must be pushed with an appropriate infusion fluid, such as: intravenous infusion of sodium chloride (0.9% w/v).

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Instructions for opening the vial

The vials have the "One Point of Cut" (UPC) opening system and must be opened following the instructions below:

• Hold the lower part of the vial with one hand, as indicated in figure 1.
• Place the other hand on the top of the vial, positioning the thumb above the colored point and press, as indicated in figure 2.

Figure 2