Cisatracurium Normon 2 mg/ml solution for injection and infusion EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Cisatracurium NORMON 2 mg/ml solution for injection and for infusion EFG
Cisatracurium
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, nurse or pharmacist.
- If you experience any side effects, talk to your doctor, nurse or pharmacist, even if they are side effects not listed in this leaflet.
Leaflet contents:
- What Cisatracurium NORMON is and what it is used for
- Before you use Cisatracurium NORMON
- How to use Cisatracurium NORMON
- Possible side effects
- How to store Cisatracurium NORMON
- Further information
1. What Cisatracurio Normon is and what it is used for
Cisatracurio Normon is a medicine containing cisatracurium. It belongs to a group of medicines called muscle relaxants.
Cisatracurio Normon is used:
- To relax muscles during surgical procedures, including cardiac surgery, in both adults and children over 1 month of age.
- To facilitate insertion of a tube into the trachea (endotracheal intubation) when mechanical ventilation is required.
- To relax muscles in adults in intensive care settings.
2. Before using Cisatracurium Normon
Do not use Cisatracurium NORMON if
- You are allergic (hypersensitive) to cisatracurium besylate or to any of the other components of Cisatracurium NORMON (see section 6).
- You have previously had an allergic reaction to an anaesthetic.
Do not use Cisatracurium NORMON if any of the above apply to you. If you are unsure, speak with your doctor, nurse, or pharmacist before using Cisatracurium NORMON.
Take special care with Cisatracurium NORMON
Talk to your doctor, nurse, or pharmacist before starting treatment with Cisatracurium NORMON if:
- You have muscle weakness, fatigue, or difficulty coordinating movements (myasthenia gravis)
- You suffer from a neuromuscular disease causing muscle wasting, paralysis, motor neuron disease, or cerebral palsy
- You have had burns requiring medical treatment
- You have ever had an allergic reaction to any muscle relaxant administered during surgery.
If you are unsure whether any of the above apply to you, speak with your doctor, nurse, or pharmacist before receiving Cisatracurium NORMON.
Children
The use of this medicine is not recommended in children under 1 month of age.
Use of other medicines
Inform your doctor, nurse, or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
This is because some medicines may affect how well Cisatracurium NORMON works or may cause adverse effects.
In particular, inform your doctor, nurse, or pharmacist 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 fluid (diuretics), such as furosemide
- Medicines for joint inflammation, such as chloroquine or penicillamine
- Steroids
- Medicines for seizures (epilepsy), such as phenytoin or carbamazepine
- Medicines used in psychiatry, such as lithium, monoamine oxidase inhibitors (MAOIs), or chlorpromazine (which may also be used to prevent vomiting)
- Medicines containing magnesium (such as those used for indigestion or heartburn)
- Medicines for Alzheimer's disease (anticholinesterases such as donepezil).
Pregnancy and breast-feeding
A harmful effect of cisatracurium on the 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.
Pregnancy: Cisatracurium NORMON should not be used during pregnancy.
Breast-feeding: Breastfeeding must be interrupted during treatment with Cisatracurium NORMON.
If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine may affect your ability to drive or operate machinery. If you are staying in hospital for only one day, 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 Cisatracurium Normon
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.
Cisatracurium NORMON may be administered:
- as a single intravenous injection (intravenous bolus injection)
- as a continuous intravenous infusion. This is when the medicine is given slowly over a prolonged period of time.
Your doctor will determine the appropriate dose and duration of treatment according to your specific needs.
This will depend on:
- body weight
- the degree and duration of muscle relaxation required
- the expected patient response to the medicine.
If you receive more Cisatracurium NORMON than you should
Cisatracurium NORMON will always be administered under properly controlled conditions. However, if you think you have been given more medicine than intended, inform your doctor or nurse immediately.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Cisatracurium NORMON can produce adverse effects, although not everyone experiences them. The adverse effects that may occasionally occur with this medicine are:
Allergic reactions (may affect up to 1 in 10,000 patients)
If you have experienced 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 urticarial rash anywhere on the body
- collapse and anaphylactic shock.
Consult your doctor, nurse or pharmacist if you notice any of the following:
Frequent adverse effects (may affect up to 1 in 10 patients)
- slowing of the heart rate
- decrease in blood pressure (hypotension)
Uncommon adverse effects (may affect up to 1 in 100 patients)
- rash, redness of the skin
- wheezing or coughing
Very rare adverse effects (may affect up to 1 in 10,000 patients)
- muscle weakness or muscle pain
If you consider any of these adverse effects you are experiencing to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor, nurse or pharmacist.
5. Storage of Cisatracurium Normon
Keep this medicine out of the reach and sight of children.
Store in the refrigerator (between 2°C and 8°C). Do not freeze.
Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date refers to the last day of the month indicated.
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 must not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine appropriately. This helps protect the environment.
6. Additional Information
Composition of Cisatracurium NORMON
The active substance is cisatracurium (as besilate). Each ml of solution contains 2 mg of cisatracurium.
The other components are: benzene sulfonic acid solution and water for injections.
Appearance of the product and contents of the container
Cisatracurium NORMON 2 mg/ml is an injectable and infusion solution presented in vials of 2.5, 5 and 10 ml. Each pack contains 5 vials.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
This summary of product characteristics was approved in June 2021
This information is intended solely for healthcare professionals:
This product is for single use only. Use only clear, almost colorless or slightly yellowish/greenish solutions. The product should be visually inspected before use; if there is any change in appearance or if the container is damaged, the product must be discarded.
Diluted Cisatracurium NORMON 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 intravenous infusion (0.9% w/v).
- Glucose intravenous infusion (5% w/v).
- 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 performed immediately before use. If this is not possible, the solution may be stored at 2–8°C for no more than 24 hours.
Cisatracurium NORMON 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 device: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride, and sufentanil citrate. When other drugs are administered through the same needle or cannula as Cisatracurium NORMON, it is recommended that each drug be flushed through with an adequate volume of a suitable intravenous fluid, such as sodium chloride intravenous infusion (0.9% w/v).
As with other intravenously administered drugs, when a small vein is selected as the injection site, Cisatracurium NORMON should be flushed through with an appropriate infusion fluid, such as sodium chloride intravenous infusion (0.9% w/v).
OTHER PRESENTATIONS
Cisatracurium NORMON 5 mg/ml solution for injection and infusion EFG.
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/