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REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION

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About the medicine

How to use REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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:

  1. What Remifentanilo Noridem is and what it is used for
  2. What you need to know before you use Remifentanilo Noridem
  3. How to use Remifentanilo Noridem
  4. Possible side effects
  5. Storage of Remifentanilo Noridem
  6. 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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

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Discuss questions about REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Andrei Popov

General medicine 7 years exp.

Dr. Andrei Popov is a family physician with specialized training in the management of chronic pain. He provides video consultations for adults in Spain and across Europe: whether you have been living with pain for months that no one has been able to properly explain, or you need to resolve a health issue without waiting weeks for an appointment.

His approach is clear: to listen, organize your case, and provide you with a practical roadmap based on evidence-based medicine and adapted to your medical history and personal needs.

Pain: how he can help

  • Chronic pain (more than 3 months
  • Migraine and recurrent or high-intensity headaches
  •  Neck, lower back, back and joint pain
  •  Post-traumatic pain after injuries or surgeries
  •  Pain of neurological origin: neuralgia, neuropathic pain, fibromyalgia

General medicine

  • Frequent respiratory infections (cold, flu, persistent cough)
  • Hypertension, diabetes and metabolic disorders
  • Review of laboratory tests and MRI/CT reports (explained in clear language)
  • Preventive medicine and health monitoring
  • Second opinions and treatment adjustments (when clinically appropriate)

What the consultation is like
 Each session lasts up to 30 minutes. We review symptoms, medical history, medications and any tests you provide, and you finish the consultation with a clear treatment plan, defined next steps, and criteria to understand when follow-up may be needed. If warning signs are detected, he will clearly advise whether you need in-person care or urgent medical attention.

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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50
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Doctor

Joao Silva

General medicine 6 years exp.

Dr. João Silva is a physician with training and experience in the field of General and Family Medicine, dedicated to providing healthcare focused on the well-being and quality of life of his patients. Throughout his professional career, he has developed broad clinical competencies, striving to maintain a medical practice based on scientific evidence and continuous knowledge updates.

Between 2013 and 2019, he completed the Integrated Master's Degree in Medicine at the Abel Salazar Institute of Biomedical Sciences in Porto, where he acquired a solid academic and clinical education.

Subsequently, between January 2021 and December 2021, he completed the General Internship at the Entre Douro e Vouga Hospital Center in Santa Maria da Feira, where he had the opportunity to work in different hospital settings and deepen his competencies in several areas of medicine.

From January 2022 until March 2026, he works as a Resident Physician in General and Family Medicine at USF Salvador Machado in Oliveira de Azeméis, developing clinical activities in primary healthcare, follow-up of chronic patients, and health promotion in the community.

Complementing his medical training, Dr. João Silva also completed a Postgraduate Degree in Continuing and Palliative Care at CESPU, strengthening his preparation in the comprehensive approach to patient care, especially in situations requiring prolonged care and multidisciplinary support.

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€55
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Bulat Garipov

General medicine 15 years exp.

Dr. Bulat Garipov is a radiologist with more than 15 years of experience, specializing in magnetic resonance imaging (MRI). Throughout his professional career, he has worked in leading diagnostic imaging centers, both in on-site practice and teleradiology, which has allowed him to develop a broad and versatile approach to radiology.

Over the years, he has gained solid experience in interpreting MRI studies in various areas, including:

  •  Neuroimaging
  •  Musculoskeletal system (MSK)
  •  Angiography
  •  Abdomen and pelvis
  •  Soft tissues

Additionally, Dr. Garipov is open to new collaboration opportunities in radiology and teleradiology projects. He offers his expertise in MRI, providing both first and second readings of studies, as well as advanced image interpretation, ensuring accurate and high-quality diagnostics.

You could consult Dr. Bulat Garipov in cases where accurate interpretation of MRI studies or a second expert opinion is required. His expertise is especially valuable in cases of suspected neurological conditions, back and joint pain, vascular disorders, as well as in the diagnosis of abdominal and pelvic diseases. The doctor also provides support in complex or unclear clinical situations, including the review of previously performed studies, which helps improve diagnostic accuracy and determine the optimal treatment strategy. A teleradiology format is available, allowing you to receive a professional opinion remotely.

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€60

Frequently Asked Questions

Is a prescription required for REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION?
REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION?
The active ingredient in REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION is remifentanil. This information helps identify medicines with the same composition but different brand names.
Who manufactures REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION?
REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION is manufactured by Noridem Enterprises Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to REMIFENTANIL NORIDEM 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION?
Other medicines with the same active substance (remifentanil) include REMIFENTANIL KERN PHARMA 1 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION, REMIFENTANIL KERN PHARMA 2 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION, REMIFENTANIL KERN PHARMA 5 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION AND INFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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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

Drug Administration Rate (micrograms/kg/min)

Infusion Administration Rate (mL/kg/h) for Solution Concentrations of:

20 micrograms/mL 1 mg/50 mL

25 micrograms/mL 1 mg/40 mL

50 micrograms/mL 1 mg/20 mL

250 micrograms/mL 10 mg/40 mL

0.0125

0.038

0.03

0.015

No recommendation

0.025

0.075

0.06

0.03

No recommendation

0.05

0.15

0.12

0.06

0.012

0.075

0.23

0.18

0.09

0.018

0.1

0.3

0.24

0.12

0.024

0.15

0.45

0.36

0.18

0.036

0.2

0.6

0.48

0.24

0.048

0.25

0.75

0.6

0.3

0.06

0.5

1.5

1.2

0.6

0.12

0.75

2.25

1.8

0.9

0.18

1.0

3.0

2.4

1.2

0.24

1.25

3.75

3.0

1.5

0.3

1.5

4.5

3.6

1.8

0.36

1.75

5.25

4.2

2.1

0.42

2.0

6.0

4.8

2.4

0.48

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

Infusion Rate (micrograms/kg/min)

Patient Body Weight (kg)

5

10

20

30

40

50

60

70

80

90

100

0.0125

0.188

0.375

0.75

1.125

1.5

1.875

2.25

2.625

3.0

3.375

0.025

0.375

0.75

1.5

2.25

3.0

3.75

4.5

5.25

6.0

6.75

0.05

0.75

1.5

3.0

4.5

6.0

7.5

9.0

10.5

12.0

13.5

0.075

1.125

2.25

4.5

6.75

9.0

11.25

13.5

15.75

18.0

20.25

0.1

1.5

3.0

6.0

9.0

12.0

15.0

18.0

21.0

24.0

27.0

0.15

2.25

4.5

9.0

13.5

18.0

22.5

27.0

31.5

36.0

40.5

0.2

3.0

6.0

12.0

18.0

24.0

30.0

36.0

42.0

48.0

54.0

0.25

3.75

7.5

15.0

22.5

30.0

37.5

45.0

52.5

60.0

67.5

0.3

4.5

9.0

18.0

27.0

36.0

45.0

54.0

63.0

72.0

81.0

0.35

5.25

10.5

21.0

31.5

42.0

52.5

63.0

73.5

84.0

94.5

0.4

6.0

12.0

24.0

36.0

48.0

60.0

72.0

84.0

96.0

108.0

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

Infusion Rate (micrograms/kg/min)

Patient Body Weight (kg)

10

20

30

40

50

60

70

80

90

100

0.0125

0.3

0.6

0.9

1.2

1.5

1.8

2.1

2.4

2.7

3.0

0.025

0.6

1.2

1.8

2.4

3.0

3.6

4.2

4.8

5.4

6.0

0.05

1.2

2.4

3.6

4.8

6.0

7.2

8.4

9.6

10.8

12.0

0.075

1.8

3.6

5.4

7.2

9.0

10.8

12.6

14.4

16.2

18.0

0.1

2.4

4.8

7.2

9.6

12.0

14.4

16.8

19.2

21.6

24.0

0.15

3.6

7.2

10.8

14.4

18.0

21.6

25.2

28.8

32.4

36.0

0.2

4.8

9.6

14.4

19.2

24.0

28.8

33.6

38.4

43.2

48.0

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

Infusion Rate (micrograms/kg/min)

Patient Body Weight (kg)

30

40

50

60

70

80

90

100

0.025

0.9

1.2

1.5

1.8

2.1

2.4

2.7

3.0

0.05

1.8

2.4

3.0

3.6

4.2

4.8

5.4

6.0

0.075

2.7

3.6

4.5

5.4

6.3

7.2

8.1

9.0

0.1

3.6

4.8

6.0

7.2

8.4

9.6

10.8

12.0

0.15

5.4

7.2

9.0

10.8

12.6

14.4

16.2

18.0

0.2

7.2

9.6

12.0

14.4

16.8

19.2

21.6

24.0

0.25

9.0

12.0

15.0

18.0

21.0

24.0

27.0

30.0

0.5

18.0

24.0

30.0

36.0

42.0

48.0

54.0

60.0

0.75

27.0

36.0

45.0

54.0

63.0

72.0

81.0

90.0

1.0

36.0

48.0

60.0

72.0

84.0

96.0

108.0

120.0

1.25

45.0

60.0

75.0

90.0

105.0

120.0

135.0

150.0

1.5

54.0

72.0

90.0

108.0

126.0

144.0

162.0

180.0

1.75

63.0

84.0

105.0

126.0

147.0

168.0

189.0

210.0

2.0

72.0

96.0

120.0

144.0

168.0

192.0

216.0

240.0

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

Infusion Rate (micrograms/kg/min)

Patient Body Weight (kg)

30

40

50

60

70

80

90

100

0.1

0.72

0.96

1.20

1.44

1.68

1.92

2.16

2.40

0.15

1.08

1.44

1.80

2.16

2.52

2.88

3.24

3.60

0.2

1.44

1.92

2.40

2.88

3.36

3.84

4.32

4.80

0.25

1.80

2.40

3.00

3.60

4.20

4.80

5.40

6.00

0.5

3.60

4.80

6.00

7.20

8.40

9.60

10.80

12.00

0.75

5.40

7.20

9.00

10.80

12.60

14.40

16.20

18.00

1.0

7.20

9.60

12.00

14.40

16.80

19.20

21.60

24.00

0,50

3,60

4,80

6,00

7,20

8,40

9,60

10,80

12,00

0,75

5,40

7,20

9,00

10,80

12,60

14,40

16,20

18,00

1,0

7,20

9,60

12,00

14,40

16,80

19,20

21,60

24,00

1,25

9,00

12,00

15,00

18,00

21,00

24,00

27,00

30,00

1,5

10,80

14,40

18,00

21,60

25,20

28,80

32,40

36,00

1,75

12,60

16,80

21,00

25,20

29,40

33,60

37,80

42,00

2,0

14,40

19,20

24,00

28,80

33,60

38,40

43,20

48,00

.