REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION
How to use REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Remifentanilo Noridem 2 mg powder for concentrate for solution for injection and infusion EFG
Remifentanil hydrochloride
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 experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
The name of your medicine isRemifentanilo Noridem2mgpowder for concentrate for solution for injection and infusion EFG.
In the rest of this leaflet, your medicinewill be calledRemifentanilo Noridem.
Contents of the pack:
- What Remifentanilo Noridem is and what it is used for
- What you need to know before you use Remifentanilo Noridem
- How to use Remifentanilo Noridem
- Possible side effects
- Storage of Remifentanilo Noridem
- Contents of the pack and further information
1. What Remifentanilo Noridem is and what it is used for
Remifentanilo Noridem contains a medicine called remifentanil which belongs to a group of medicines called opioids.
Remifentanilo Noridem is used together with other medicines called anesthetics:
- to help you fall asleep beforesurgery
- to prevent pain and keep you asleep duringsurgery
to keep you drowsy and prevent pain while you are being treated in an Intensive Care Unit.
2. What you need to know before you use Remifentanilo Noridem
Do not use Remifentanilo Noridem if:
- you are allergic (hypersensitive) to remifentanil or any of the other ingredients of this medicine (listed in section 6)
- you are allergic (hypersensitive) to any other pain-relieving medicine similar to fentanyl and related to the class of medicines known as opioids
If you are not sure if you are in one of these situations, consult your doctor, pharmacist or healthcare professional before using Remifentanilo Noridem.
Warnings and precautions:
Talk to your doctor or pharmacist before you start using Remifentanilo Noridem if:
- you are allergic (hypersensitive) to any other opioid medicine, such as morphine or codeine
- you are over 65 years old
- you are dehydrated or have lost a lot of blood
- you have not been feeling well or have been feeling weak
- you are overweight
- you or someone in your family has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction")
- you are a smoker
- you have ever had mood problems (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental illnesses
If you are not sure if you are in one of these situations, consult your doctor, pharmacist or healthcare professional before using Remifentanilo Noridem.
This medicine contains remifentanil which is an opioid. Repeated use of opioids can make the medicine less effective (you get used to its effect). It can also cause dependence and abuse, which can lead to a potentially life-threatening overdose. If you are concerned that you may become dependent on Remifentanilo Noridem, it is important that you talk to your doctor.
Occasionally, withdrawal reactions (e.g. rapid heartbeat, high blood pressure and agitation) have been reported after sudden stop of treatment with this medicine, especially when treatment was given for more than 3 days (see also section 4. Possible side effects). If you experience these symptoms, your doctor may restart treatment with the medicine and gradually reduce the dose.
Using Remifentanilo Noridem with other medicines
Tell your doctor or pharmacist if you are using or have recently used or might use other medicines, including those bought without a prescription and herbal medicines. This is because Remifentanilo Noridem can interact with other medicines, causing side effects.
It is especially important that you tell your doctor or pharmacist if you are taking:
- medicines to control blood pressure or heart problems, such as beta-blockers (including atenolol, metoprolol, carvedilol, propranolol and bisoprolol) or calcium channel blockers (including amlodipine, diltiazem and nifedipine)
- medicines to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs) and monoamine oxidase inhibitors (MAOIs). It is not recommended to use these medicines at the same time as Remifentanilo Noridem, as they may increase the risk of serotonin syndrome, a potentially life-threatening disease
The concomitant use of opioids and other drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose and respiratory depression, and can be potentially life-threatening
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine
If you receive this medicine during childbirth or shortly before delivery, it may affect your baby's breathing. You and your baby will be monitored for signs of excessive sleepiness or difficulty breathing
Driving and using machines
If you are only in the hospital during the day, your doctor will tell you how long you should wait before leaving the hospital or driving. It may be dangerous to drive too soon after having surgery
This medicine may affect your ability to drive because it can make you feel drowsy or dizzy
- Do not drive while taking this medicine until you know how it affects you
Ask your doctor or pharmacist if you are not sure if you can drive safely while taking this medicine
3. How to use Remifentanilo Noridem
Administration by injection
This medicine should never be administered by yourself. This medicine will always be administered by qualified healthcare professionals
Remifentanilo Noridem can be administered:
- as a single injection into a vein
- as a continuous infusion (drip) into a vein, in case you need to receive the medicine over a longer period of time
The way you are given the medicine and the dose you receive will depend on:
- your weight
- the type of surgery you are having
- the level of pain that the surgery is expected to cause
- the level of sleepiness that the healthcare professionals think is best for you in the Intensive Care Unit
The dose may vary from patient to patient
If you use more Remifentanilo Noridem than you should
The effects of Remifentanilo Noridem are closely monitored during surgery and in intensive care. If you have received too much, the necessary measures will be taken promptly
If you think you have been given too much Remifentanilo, talk to your doctor or pharmacist immediately
After surgery
Tell your doctor or healthcare professionals if you are in pain. If you are in pain after surgery, they may give you other pain-relieving medicines to relieve it
4. Possible side effects
Like all medicines, Remifentanilo Noridem can cause side effects, although not everybody gets them. The following side effects may happen with this medicine
Some people may be allergic to Remifentanil. Tell your doctor or healthcare professionals immediately if you feel:
Rare(may affect up to 1 in 1,000 people)
- sudden attacks of sneezing and pain or feeling of compression in the chest
- swelling of the eyelids, face, lips, mouth or tongue
- hives with lumps or rash on any part of your body
- a faint
Tell your doctor as soon as possibleif you feel any of the following effects:
Very common(may affect more than 1 in 10 people)
- muscle stiffness
- low blood pressure
- nausea or vomiting
Common(may affect up to 1 in 10 people)
- slow heartbeat
- shallow breathing or temporary stop of breathing
- itching
- coughing
Uncommon(may affect up to 1 in 100 people)
- breathing problems (hypoxia)
- constipation
Rare(may affect up to 1 in 1,000 people)
- allergic reactions
- heart stop
Unknown(cannot be estimated from the available data)
- physical need for remifentanil (dependence) or need to increase the dose over time to get the same effect (tolerance)
- seizures (convulsions)
- a type of irregular heartbeat (atrioventricular block)
- irregular heartbeat (arrhythmia)
- withdrawal syndrome (may occur with the following side effects: increased heart rate, high blood pressure, feeling of agitation or restlessness, nausea, vomiting, diarrhea, anxiety, chills, tremors and sweating)
Other side effects that may occur when you wake up after having an anesthetic:
Common(may affect up to 1 in 10 people)
- shivering
- high blood pressure
Uncommon(may affect up to 1 in 100 people)
- pain
Rare(may affect up to 1 in 1,000 people)
- feeling extremely calm or drowsy (sedation)
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: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine
5. Storage of Remifentanilo Noridem
Keep this medicine out of the sight and reach of children
Do not use Remifentanilo Noridem after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month
Do not use the reconstituted product if you notice that the solution is not clear, colorless and practically free of particles
Do not store above 25°C. Store the vial in its original packaging to protect it from light
Once reconstituted, use Remifentanilo Noridem immediately. The unused solution should not be disposed of via wastewater or household waste. Your doctor or healthcare professional will dispose of any unused medicines. This will help protect the environment
6. Container Content and Additional Information
Composition of Remifentanil Noridem
- The active ingredient is remifentanil hydrochloride.
- The other components are glycine and hydrochloric acid (for pH adjustment).
Appearance of the Product and Container Content
Remifentanil Noridem is a white or almost white, lyophilized, sterile, and pyrogen-free powder. This powder must be mixed with a suitable fluid before injection. Once mixed, the resulting Remifentanil Noridem solution is clear and colorless.
Remifentanil Noridem powder for concentrate for solution for injection or infusion is supplied in glass vials with bromobutyl rubber stoppers, containing 1 mg of remifentanil (as remifentanil hydrochloride).
Each of these Remifentanil Noridem dosages is supplied in cardboard boxes containing 5 and 10 vials.
Only certain package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.
Manufacturer:DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Attica, Greece.
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
United Kingdom: | Remifentanil Noridem 1mg Powder for Concentrate for Solution for Injection or Infusion |
Ireland: | Remifentanil Noridem 1mg Powder for Concentrate for Solution for Injection or Infusion |
Austria: | Remifentanil/Noridem 1mg Pulver für ein Konzentrat zur Herstellung einer Injektions- oder Infusionslösung |
Greece: | Remifentanil/Noridem Κόνις για πυκνό σκεύασμα για Παρασκευή Διαλύματος προς Ένεση ή Έγχυση, 1mg/vial |
Spain: | Remifentanilo Noridem 1 mg polvo para concentrado para solución inyectable y para perfusión EFG |
Date of the Last Revision of this Leaflet05/2022.
Detailed and updated 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/
The following information is intended exclusively for healthcare professionals: Consult the complete prescribing information in the Product Characteristics. The information provided in this section is the instructions for the preparation of Remifentanil Noridem before administration and the guidelines for the infusion rates of Remifentanil Noridem for manually controlled infusion. PREPARATION GUIDE for Remifentanil Noridem 1 mg Powder for Concentrate for Solution for Injection or Infusion Remifentanil Noridem is a sterile, pyrogen-free, and preservative-free lyophilized powder, white or almost white, which must be reconstituted before use. Remifentanil Noridem is available in glass vials containing 1 mg of remifentanil base. The vials should not be stored above 25°C. When reconstituted as recommended, the Remifentanil Noridem solutions are clear and colorless and contain 1 mg/mL of remifentanil base, in the form of remifentanil hydrochloride. Remifentanil Noridem should not be administered without further dilution after reconstitution of the lyophilized powder. Reconstitution of the Lyophilized Powder Remifentanil Noridem should be prepared for intravenous use by adding, as appropriate, 1, 2, or 5 mL of diluent (see the list of diluents in "Further Dilution") to obtain a reconstituted solution with a concentration of 1 mg/mL of remifentanil. This reconstituted solution is clear, colorless, and practically free of particles. After reconstitution, visually inspect the product (whenever the container allows) to determine the presence of particles, coloration, or container damage. Discard any solution with these defects. The reconstituted product is for single use. Any unused material should be discarded. Further Dilution Once reconstituted, Remifentanil Noridem should not be administered by manually controlled infusion without further dilution to concentrations of 20 to 250 micrograms/mL (50 micrograms/mL is the recommended dilution for adults and 20 to 25 micrograms/mL for pediatric patients 1 year of age or older, when used for maintenance of anesthesia). The use of Remifentanil Noridem is not recommended in pediatric patients under 18 years of age for administration of analgesia in intensive care patients with mechanical ventilation. Once reconstituted, Remifentanil Noridem should not be administered by Target-Controlled Infusion (TCI) without further dilution (the recommended dilution for TCI is 20 to 50 micrograms/mL). The chosen dilution depends on the technical capability of the infusion device and the anticipated needs of the patient. For dilution, one of the following intravenous fluids should be used: Water for injections 5% Glucose solution for injection 5% Glucose and 0.9% Sodium Chloride solution for injection 0.9% Sodium Chloride solution for injection 0.45% Sodium Chloride solution for injection After dilution, visually inspect the product to ensure it is clear, colorless, practically free of particles, and the container is not damaged. Discard any solution with these defects. Chemical and physical stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions of the reconstituted solution prior to use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the reconstitution/dilution has taken place under controlled and validated aseptic conditions. However, Remifentanil Noridem does not contain any antimicrobial preservative, and therefore, care should be taken to ensure the sterility of the prepared solutions, and the reconstituted product should be used promptly and any unused material discarded. Compatibility of Remifentanil Noridem has been demonstrated with the following intravenous fluids when administered through a Y-connector: Ringer's Lactate solution for injection Ringer's Lactate and 5% Glucose solution for injection It has been demonstrated that Remifentanil Noridem is compatible with propofol when administered through a Y-connector. GUIDELINES FOR INFUSION RATES The following tables provide recommendations for infusion rates of Remifentanil Noridem for manually controlled infusion: Table 1. Infusion Rates (mL/kg/h) of Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion
Table 2. Infusion Rates (mL/h) for a Solution of 20 micrograms/mL of Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion
Table 3. Infusion Rates (mL/h) for a Solution of 25 micrograms/mL of Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion
Table 4. Infusion Rates (mL/h) for a Solution of 50 micrograms/mL of Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion
Table 5. Infusion Rates (mL/h) for a Solution of 250 micrograms/mL of Remifentanil Noridem Powder for Concentrate for Solution for Injection or Infusion
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