Cisatracurium Sala 5 mg/ml solution for injection and infusion EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the User
Cisatracurium Sala 5 mg/ml solution for injection and infusion EFG
Read the entire 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, pharmacist, or nurse.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet Contents:
- What Cisatracurium Sala is and what it is used for
- What you need to know before using Cisatracurium Sala
- How to use Cisatracurium Sala
- Possible side effects
- How to store Cisatracurium Sala
- Contents of the pack and other information
1. What Cisatracurium Sala is and what it is used for
Cisatracurium Sala contains an active substance called cisatracurium, which belongs to a group of medicines known as muscle relaxants.
Cisatracurium Sala is used:
- to relax muscles during surgical procedures, 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), when mechanical assistance for breathing is required.
- to relax muscles in adults in intensive care units.
2. What you need to know before using Cisatracurium Sala
Do not use Cisatracurium Sala:
- if you are allergic to cisatracurium, to any other muscle relaxant, or to any of the other components of Cisatracurium (listed in section 6)
- if you have previously had an allergic reaction to an anaesthetic.
Do not use Cisatracurium if any of the above conditions apply to you. If you are unsure, speak with your doctor, nurse, or pharmacist before using Cisatracurium.
Warnings and precautions
Talk to your doctor, nurse, or pharmacist before using Cisatracurium:
- if you have muscle weakness, fatigue, or difficulty coordinating your movements (myasthenia gravis)
- if you have a neuromuscular disease causing muscle wasting, paralysis, motor neuron disease, or cerebral palsy
- if you have had burns that required medical treatment
If you are unsure whether any of the above conditions apply to you, speak with your doctor, nurse, or pharmacist before being administered Cisatracurium.
Other medicines and Cisatracurium Sala
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. This includes herbal products or medications purchased without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:
- anaesthetics (used to reduce sensitivity or pain during surgery)
- antibiotics (used to treat infections)
- medicines used to treat heart rhythm disorders (antiarrhythmics)
- medicines used to treat high blood pressure (hypertension)
- medicines that help eliminate 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
- psychiatric medicines, such as lithium, *, or chlorpromazine (which may also be used to prevent vomiting)
- medicines containing 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 infant cannot be ruled out; however, it is not expected to occur 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 using machines
If you are having a day-case hospital visit, your doctor will advise you how long you should wait before driving or operating machinery. It may be dangerous to drive soon after surgery.
3. How to use Cisatracurio Sala
How the injection is administered
Under no circumstances should you attempt to administer this medicine to yourself. It must always be administered by a qualified healthcare professional.
Cisatracurio Sala may be administered:
- as a single intravenous injection (intravenous 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 dose and duration of treatment appropriate for your procedure.
This will depend on:
- body weight
- the degree and duration of muscle relaxation required
- the expected patient response to the medicine.
The use of this medicine is not recommended in children under 1 month of age.
If you receive more Cisatracurio Sala than you should
Cisatracurio Sala will always be administered under adequately controlled conditions. However, if you think you have been given more medicine than you should have, inform your doctor or nurse immediately.
If you have any further questions about the use of this medicine, ask your doctor.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If you experience any adverse effect, inform your doctor. This includes any possible adverse effect not mentioned in this leaflet.
Allergic reactions (affect fewer than 1 in every 10,000 people treated)
If you have had 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 and tongue
- skin rash or hives anywhere on the body
- collapse and anaphylactic shock.
Consult your doctor, nurse or pharmacist if you notice any of the following:
Frequent adverse effects (affect between 1 and 10 in every 100 people treated)
- slowing of the heart rate
- decrease in blood pressure (hypotension)
Uncommon adverse effects (affect between 1 and 10 in every 1,000 people treated)
- rash, redness of the skin
- wheezing or cough
Very rare adverse effects (affect fewer than 1 in every 10,000 people treated)
- muscle weakness or muscle pain
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cisatracurio Sala
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Do not use this medicine if there are visible signs of deterioration in the appearance of the solution.
Cisatracurio Sala remains stable for 21 days at 25°C. Store in a refrigerator (between 2°C and 8°C). Do not freeze.
Keep 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 portion of the infusion solution must be discarded 24 hours after preparation.
Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine properly. This helps protect the environment.
6. Contents of the pack and other information
Composition of Cisatracurio Sala
- The active substance is cisatracurium (as besylate).
- The other components are: benzenesulfonic acid and water for injections.
Appearance of the product and contents of the container
Cisatracurio 5 mg/ml solution for injection and infusion EFG is supplied in cartons containing one 30 ml clear glass vial. Each 30 ml vial contains 150 mg of cisatracurium.
Marketing Authorisation Holder and Manufacturer:
Laboratorio Reig Jofré, S.A.
Gran Capitán, 10
08970 Sant Joan Despí, Barcelona
Spain
Date of the most recent revision of this leaflet: June 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es
This information is intended for healthcare professionals only:
This product is for single use only. Use only clear, almost colourless solutions or solutions with a slightly yellowish/greenish tint. The product must be visually inspected before use; if there is any change in appearance or if the container is damaged, the product must be discarded.
Diluted Cisatracurio 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, whether in polyvinyl chloride or polypropylene containers:
- Sodium chloride 0.9% (w/v) intravenous infusion.
- Glucose 5% (w/v) intravenous infusion.
- Sodium chloride 0.18% (w/v) and glucose 4% (w/v) intravenous infusion.
- Sodium chloride 0.45% (w/v) and glucose 2.5% (w/v) intravenous infusion.
In any case, since the product does not contain antimicrobial preservatives, dilution should be carried out immediately before use. If this is not possible, it may be stored at 2–8°C for no longer than 24 hours.
Cisatracurio Sala has been shown to be compatible with the following drugs commonly used during surgical procedures when mixed under conditions simulating intravenous infusion administration via a Y-site connector: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate. When other drugs are administered through the same needle or cannula as Cisatracurio Sala, it is recommended that each drug be flushed with an appropriate volume of a suitable intravenous fluid, such as sodium chloride 0.9% (w/v) intravenous infusion.
As with other intravenously administered drugs, when a small vein is selected as the injection site, Cisatracurio Sala should be flushed with an appropriate infusion fluid, such as sodium chloride 0.9% (w/v) intravenous infusion.
Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.