CISATRACURIO SALA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Cisatracurium Sala 2 mg/ml Solution for Injection and Perfusion EFG

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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Cisatracurium Salais and what it is used for
2. What you need to know before you use Cisatracurium Sala
3. How to use Cisatracurium Sala
4. Possible side effects
5. Storage of Cisatracurium Sala
6. Contents of the pack and further information

1. What is Cisatracurium Sala and what is it used for

Cisatracurium Sala contains the active substance cisatracurium, which belongs to a group of medicines called muscle relaxants.

Cisatracurium 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 to breathe is required.
• to relax muscles in adults in Intensive Care.

2. What you need to know before you use Cisatracurium Sala

Do not use Cisatracurium Sala:

• if you are allergic to cisatracurium, any other muscle relaxant, or any of the other ingredients of Cisatracurium Sala (listed in section 6)
• if you have previously had an allergic reaction to an anesthetic.

Do not use Cisatracurium Sala if any of the above applies to you. If you are not sure, talk to your doctor, nurse, or pharmacist before using Cisatracurium Sala.

Warnings and precautions

Talk to your doctor, nurse, or pharmacist before using this medicine:

• if you have muscle weakness, tiredness, 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 not sure if any of the above applies to you, talk to your doctor, nurse, or pharmacist before you are given Cisatracurium Sala.

Other medicines and Cisatracurium Sala

Tell your doctor if you are using, have recently used, or might use any other medicines, including those obtained without a prescription. This includes herbal products or medicines obtained without a prescription.

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

• anesthetics (used to reduce sensitivity or pain during surgery)
• antibiotics (used to treat infections)
• medicines used to treat heart rhythm disorders (anti-arrhythmics)
• medicines used to treat high blood pressure (hypertension)
• medicines that help you lose 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 used in psychiatry, such as lithium, or chlorpromazine (which may also be used to prevent vomiting)
• medicines that contain magnesium (such as those used to treat indigestion or heartburn)
• anticholinesterases used to treat Alzheimer's disease, such as donepezil.

Pregnancy and breastfeeding

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

An adverse effect of cisatracurium on the breastfed infant cannot be excluded; however, it is not expected to occur if breastfeeding is resumed after the effects of the substance have disappeared. Cisatracurium is rapidly eliminated from the body. Women should not breastfeed for 3 hours after the end of treatment.

Driving and using machines

If you are going to be in the hospital for only one day, your doctor will tell you how long you should wait before you can drive and use machinery. It may be dangerous to drive soon after surgery.

3. How to use Cisatracurium Sala

How the injection is given

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

Cisatracurium Sala can be given:

• as a single injection into a vein (intravenous bolus injection)
• 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 dose and duration of treatment that is right for you.

This will depend on:

• your body weight
• the amount and duration of muscle relaxation that is needed
• the expected response of the patient to the medicine.

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

If you are given more Cisatracurium Sala than you should

Cisatracurium Sala will always be given under properly controlled conditions. However, if you think you have been given too much medicine, tell your doctor or nurse immediately.

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

If you experience any side effect, tell your doctor. This includes any possible side effect not listed in this leaflet.

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

If you have had 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 hives anywhere on the body
• collapse and anaphylactic shock.

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

Common side effects (affect between 1 and 10 in 100 people treated)

• slow heart rate
• low blood pressure (hypotension).

Uncommon side effects (affect between 1 and 10 in 1,000 people treated)

• skin rash or redness
• wheezing or coughing.

Rare side effects (affect less than 1 in 10,000 patients treated)

• muscle weakness or pain

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cisatracurium Sala

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

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Do not use this medicine if you notice visible signs of deterioration in the appearance of the solution.

Cisatracurium Sala remains stable for 21 days at 25°C. Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect from light.

If diluted, store the infusion solution between 2°C and 8°C and use within 24 hours. Any unused infusion solution should be discarded after 24 hours of preparation.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cisatracurium Sala

• The active substance is cisatracurium (as besylate).
• The other ingredients are benzenesulfonic acid and water for injections.

Appearance and packaging of the product

Cisatracurium Sala 2 mg/ml Solution for Injection and Perfusion EFG is available in:

• Transparent glass ampoules of 2.5 ml in packs of 5 (each ampoule of 2.5 ml contains 5 mg of cisatracurium).
• Transparent glass ampoules of 5 ml in packs of 5 (each ampoule of 5 ml contains 10 mg of cisatracurium).
• Transparent glass ampoules of 10 ml in packs of 5 (each ampoule of 10 ml contains 20 mg of cisatracurium).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 Sant Joan Despí, Barcelona

Spain

Date of last revision of this leaflet:

June 2020

Detailed and updated 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:

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

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

As with other intravenous drugs, when a small vein is chosen as the injection site, Cisatracurium Sala should be flushed with a suitable intravenous fluid, such as sodium chloride (0.9% w/v) infusion.

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

Instructions for opening the ampoule

The ampoules have a "One Point Cut" (UPC) opening system and should be opened following these instructions:

• Hold the lower part of the ampoule with one hand, as shown in figure 1.
• Place the other hand on the upper part of the ampoule, with the thumb on the colored point, and press, as shown in figure 2.

Figure 2