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DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution

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About the medicine

How to use DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution

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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

Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion 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 or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Dexmedetomidine Kabi and what is it used for
  2. What you need to know before you are given Dexmedetomidine Kabi
  3. How Dexmedetomidine Kabi is given
  4. Possible side effects
  5. Storing Dexmedetomidine Kabi
  6. Contents of the pack and other information

1. What is Dexmedetomidine Kabi and what is it used for

This medicine contains the active substance dexmedetomidine, which belongs to a group of medicines called sedatives. It is used to provide sedation (a state of calm, sleepiness or sleep) in adult patients in intensive care units in hospitals or conscious sedation during various diagnostic or surgical procedures.

Doctor consultation

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2. What you need to know before you are given Dexmedetomidine Kabi

Dexmedetomidine Kabi must not be given to you:

  • if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
  • if you have certain heart rhythm disorders (grade 2 or 3 heart block).
  • if you have very low blood pressure that does not respond to treatment.
  • if you have recently had a stroke or other severe episodes that affect blood supply to the brain.

Warnings and precautions

Before using this medicine, tell your doctor or nurse if you are in any of the following situations, as Dexmedetomidine Kabi should be used with caution:

  • if you have an abnormally slow heart rate (either due to disease or a high level of physical fitness) as it may increase the risk of cardiac arrest
  • if you have low blood pressure
  • if you have low blood volume, for example after bleeding
  • if you have certain heart diseases
  • if you are elderly
  • if you have a neurological disorder (e.g. head or spinal cord injuries or stroke)
  • if you have severe liver problems
  • if you have ever developed a severe fever after some medicines, especially anesthetics

This medicine may cause a large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.

A higher risk of mortality has been observed in patients 65 years or younger when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe disease upon admission to the intensive care unit and with younger age. Your doctor will decide if this medicine is still suitable for you. Your doctor will consider the benefits and risks of this medicine for you, compared to treatment with other sedatives.

Other medicines and Dexmedetomidine Kabi

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

The following medicines may increase the effect of Dexmedetomidine Kabi:

  • medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
  • medicines for severe pain (e.g. opioids such as morphine, codeine)
  • anesthetic medicines (e.g. sevoflurane, isoflurane)

If you are using medicines that lower your blood pressure and heart rate, taking them with Dexmedetomidine Kabi may increase this effect. Dexmedetomidine Kabi should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.

Dexmedetomidine Kabi should not be used during pregnancy or breastfeeding, unless clearly necessary.

Driving and using machines

Dexmedetomidine Kabi has a major impact on the ability to drive and use machines. Once you have been given Dexmedetomidine Kabi, you should not drive, operate machinery or work in hazardous situations until the effects have passed completely. Consult your doctor when you can resume these activities and this type of work.

Dexmedetomidine Kabi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially 'sodium-free'.

3. How Dexmedetomidine Kabi is given

Intensive care in hospital

This medicine is given to you by a doctor or nurse in the intensive care unit of a hospital.

Procedural sedation/conscious sedation

Dexmedetomidine Kabi is given to you by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, e.g. procedural sedation/conscious sedation.

Your doctor will decide the right dose for you. The amount of Dexmedetomidine Kabi depends on your age, body weight, overall health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidine Kabi is diluted and given to you as an infusion (drip) into your veins.

After sedation/waking up

  • Your doctor will keep you under supervision for a few hours after sedation, to make sure you are well.
  • You should not go home unless accompanied.
  • Medicines that help you sleep, cause sedation and those intended to relieve severe pain may not be recommended for a period of time after treatment with Dexmedetomidine Kabi. Consult your doctor about the use of these types of medicines and about the use of alcohol.

If you have been given too much Dexmedetomidine Kabi

If you have been given too much Dexmedetomidine Kabi, your blood pressure may go up or down, your heart beats may be slower, you may breathe more slowly and you may feel sleepier. Your doctor will know how to treat you based on your condition.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any other questions about the use of this medicine, ask your doctor.

Medicine questions

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4. Possible side effects

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

Very common (may affect more than 1 in 10 people)

  • slow heart rate
  • low or high blood pressure
  • change in breathing pattern or stopping breathing.

Common (may affect up to 1 in 10 people)

  • chest pain or heart attack
  • fast heart rate
  • low or high blood sugar levels
  • nausea, vomiting or dry mouth
  • restlessness
  • high temperature
  • symptoms after stopping the medicine.

Uncommon (may affect up to 1 in 100 people)

  • reduced heart function, cardiac arrest
  • stomach swelling
  • thirst
  • a condition where there is too much acid in the body
  • low albumin levels in the blood
  • difficulty breathing
  • hallucinations
  • the medicine is not effective enough.

Rare (may affect up to 1 in 1,000 people)

  • large amount of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if this occurs.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dexmedetomidine Kabi

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 and label after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use if the vial is damaged or broken.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Dexmedetomidine Kabi

  • The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
  • The other ingredients are sodium chloride and water for injections.

Each 2 ml vial contains 200 micrograms of dexmedetomidine.

Each 4 ml vial contains 400 micrograms of dexmedetomidine.

Each 10 ml vial contains 1000 micrograms of dexmedetomidine.

The concentration of the final solution after dilution should be 4 micrograms/ml or 8 micrograms/ml.

Appearance and packaging

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution.

Packaging

2 ml, 4 ml or 10 ml glass vials

Pack sizes

10 vials of 2 ml

25 vials of 2 ml

1 vial of 4 ml

4 vials of 4 ml

10 vials of 4 ml

4 vials of 10 ml

10 vials of 10 ml

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Fresenius Kabi España, S.A.U.

Torre Mapfre-Vila Olímpica

Marina 16-18, 08005 - Barcelona

Spain

Manufacturer

Fresenius Kabi Austria GmbH

Hafnerstrasse 36, 8055 - Graz

Austria

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State

Marketing authorisation holder

Austria

Dexmedetomidin Kabi 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium

Dexmedetomidine Kabi 100 mcg/ml, Concentraat voor oplossing voor infusie Solution à diluer pour perfusion Konzentrat zur Herstellung einer Infusionslösung

Bulgaria

??????????????? ???? 100 ??????????/ml ?????????? ?? ?????????? ???????

Croatia

Deksmedetomidin Kabi 100 mikrograma/ml koncentrat za otopinu za infuziju

Cyprus

Dexmedetomidine/Kabi 100 μg/mL πυκν? δι?λυμα για παρασκευ? διαλ?ματος προς ?γχυση

Czech Republic

Dexmedetomidine Kabi

Denmark

Dexmedetomidine Kabi

Estonia

Dexmedetomidine Kabi

Finland

Dexmedetomidine Kabi 100 µg/ml infuusiokonsentraatti, liuosta varten

France

DEXMEDETOMIDINE KABI 100 microgrammes/mL, solution à diluer pour perfusion

Germany

Dexmedetomidin Kabi 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Greece

Dexmedetomidine/Kabi 100 μg/mL πυκν? δι?λυμα για παρασκευ? διαλ?ματος προς ?γχυση

Hungary

Dexmedetomidine Kabi 100 mikrogramm/ml koncentrátum oldatos infúzióhoz

Ireland

Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion

Italy

Dexmedetomidina Kabi

Lithuania

Dexmedetomidine Kabi 100 mikrogramu/ml koncentratas infuziniam tirpalui

Luxembourg

Dexmedetomidin Kabi 100 µg/ml Konzentrat zur Herstellung einer Infusionslösung

Malta

Dexmedetomidine Kabi 100 micrograms/mL concentrate for solution for infusion

Netherlands

Dexmedetomidine Kabi 100 mcg/ml, concentraat voor oplossing voor infusie

Norway

Dexmedetomidine Kabi

Poland

Dexmedetomidine Kabi

Portugal

Dexmedetomidina Kabi

Romania

Dexmedetomidina Kabi 100 micrograme/ml concentrat pentru solu?ie perfuzabila

Slovakia

Dexmedetomidine Kabi 100 µg/mL

Slovenia

Deksmedetomidin Kabi 100 mikrogramov/ml koncentrat za raztopino za infundiranje

Spain

Dexmedetomidina Kabi 100 µg/mL concentrado para solución para perfusión EFG

Sweden

Dexmedetomidine Kabi

United Kingdom (Northern Ireland)

Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion

Date of last revision of this leaflet: October 2022

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/

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This information is intended only for healthcare professionals:

Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion EFG

Method of administration

Dexmedetomidine Kabi should be administered by healthcare professionals experienced in the management of patients who require intensive care or in the anaesthetic management of patients in the operating room. It should be administered only as an intravenous infusion diluted using a controlled infusion device.

Dexmedetomidine Kabi can be diluted in the following infusion solutions to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration:

  • Sodium chloride 9 mg/ml (0.9%)
  • Glucose 50 mg/ml (5%)
  • Ringer's solution
  • Lactated Ringer's solution
  • Manitol 200 mg/ml (20%)

See below for the volumes needed to prepare the infusion in a table.

In case a concentration of 4 micrograms/ml is required:

Volume of Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion

Volume of diluent

Total volume of infusion

2 ml

48 ml

50 ml

4 ml

96 ml

100 ml

10 ml

240 ml

250 ml

20 ml

480 ml

500 ml

In case a concentration of 8 micrograms/ml is required:

Volume of Dexmedetomidine Kabi 100 micrograms/ml concentrate for solution for infusion

Volume of diluent

Total volume of infusion

4 ml

46 ml

50 ml

8 ml

92 ml

100 ml

20 ml

230 ml

250 ml

40 ml

460 ml

500 ml

The solution should be gently shaken to mix well.

Dexmedetomidine Kabi should be inspected visually for particles and coloration before administration.

Dexmedetomidine has been shown to be compatible when administered with the following intravenous fluids and medicines:

Lactated Ringer's solution, glucose 5% solution, sodium chloride 0.9% solution, mannitol 20% solution, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma substitute.

Shelf life

Chemical and physical stability in use has been demonstrated for 24 hours at 25 °C and for 24 hours between 2 °C and 8 °C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and normally should not be longer than 24 hours at 2-8°C, unless the dilution has been made in aseptic and controlled conditions.

Online doctors for DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution

Discuss questions about DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Томаш Гжеловський

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.

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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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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:

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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).
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  • 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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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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Endocrinology – Diabetes, thyroid, metabolism:
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  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
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  • Lab test analysis, therapy adjustments, medication management.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Anastasiia Hladkykh

Psychiatry 15 years exp.

Dr Anastasiia Hladkykh is a physician-psychotherapist and psychologist with over 14 years of experience working with individuals struggling with various types of addictions and their families. She provides online consultations for adults, combining medical knowledge with deep psychological support and practical tools.

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Experience and background:
  • Member of the German association Gesundheitpraktikerin and the NGO “Mit dem Sonne in jedem Herzen.”
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Frequently Asked Questions

Is a prescription required for DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution?
DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution 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 DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution?
The active ingredient in DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution is dexmedetomidine. This information helps identify medicines with the same composition but different brand names.
Who manufactures DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution?
DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution is manufactured by Fresenius Kabi España, S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution 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 DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution 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 DEXMEDETOMIDINE KABI 100 micrograms/ml concentrate for infusion solution?
Other medicines with the same active substance (dexmedetomidine) include DEXDOR 100 micrograms/ml concentrate for infusion solution (25x2 ml), DEXDOR 100 micrograms/ml concentrate for infusion solution, DEXDOR 100 micrograms/ml concentrate for infusion solution. 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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