Bg pattern

DEXMEDETOMIDINE BAXTER 100 micrograms/ml concentrate for infusion solution

Prescription review online

Prescription review online

A doctor will review your case and decide whether a prescription is medically appropriate.

Talk to a doctor about this medicine

Talk to a doctor about this medicine

Discuss your symptoms and possible next steps in a quick online consultation.

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

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

Translated with AI

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.

Show original

Introduction

Package Leaflet: Information for the User

Dexmedetomidine Baxter 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, even if you think they might be unrelated to the medicine. See section 4.

Contents of the pack:

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

1. What is Dexmedetomidine Baxter 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, drowsiness or sleep) in adult patients in intensive care units in hospitals or conscious sedation during various diagnostic or surgical procedures.

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 are given Dexmedetomidine Baxter

You should not be given Dexmedetomidine Baxter

  • 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 cardiac 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 affecting 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 this medicine should be used with caution:

  • if you have an abnormally slow heart rate (either due to a 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 an elderly person
  • if you have a neurological disorder (e.g. head or spinal cord injury or stroke)
  • if you have severe liver problems
  • if you have ever developed a severe fever after using certain 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 aged 65 years or less when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe illness at 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 Baxter

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 this medicine:

  • 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 together with this medicine may increase this effect. This medicine should not be used with medicines that cause temporary paralysis.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy or breastfeeding, unless clearly necessary.

Consult your doctor before using this medicine.

Driving and using machines

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

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; this is essentially "sodium-free".

3. How to use Dexmedetomidine Baxter

Intensive Care Hospitalization

This medicine will be administered by a doctor or nurse in the intensive care unit of a hospital.

Procedural Sedation/Conscious Sedation

This medicine will be administered by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, for example, procedural sedation/conscious sedation.

Your doctor will decide the suitable dose for you. The amount of dexmedetomidine depends on your age, body weight, general state of health, the level of sedation required 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.

This medicine is diluted and administered 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 or relieve severe pain may not be recommended for some time after treatment with this medicine. Consult your doctor about the use of these types of medicines and about alcohol consumption.

If you have been given too much Dexmedetomidine Baxter

If you have been given too much dexmedetomidine, your blood pressure may rise or fall, your heartbeats may slow down, you may breathe more slowly and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

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

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

Very common (affect more than 1 in 10 users)

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

Common (affect between 1 in 10 and 1 in 100 users)

  • 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 (affect between 1 in 100 and 1 in 1,000 users)

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

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if you think they might be unrelated to the medicine. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine Baxter

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 label and carton after EXP.

This medicine does not require any special storage temperature.

After dilution

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, unless the dilution method excludes the risk of microbiological contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Do not refrigerate.

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

Composition of Dexmedetomidine Baxter

  • The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine. Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).

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

The other ingredients are sodium chloride and water for injections.

Appearance of Dexmedetomidine Baxter and pack contents

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution.

Pack

2 ml glass vials

Pack size

5 vials of 2 ml

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Baxter Holding B.V.

Kobaltweg 49

3542 CE Utrecht

Netherlands

Manufacturer:

UAB Norameda

Meistru 8a, Vilnius

02189, Lithuania

or

Bieffe Medital S.P.A

Via Nuova Provinciale

23034-Grosotto (SO), Italy

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Baxter, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Dexmedetomidine Baxter 100 microgram/ml concentraat voor oplossing voor infusie

Austria: Dexmedetomidin Baxter 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium: Dexmedetomidine Baxter 100 microgrammes/ml solution à diluer pour perfusion

Denmark: Dexmedetomidine Baxter

Finland: Dexmedetomidine Baxter 100 mikrog/ml infuusiokonsentraatti, liuosta varten

Germany: Dexmedetomidin Baxter 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Greece: Dexmedetomidine/Baxter 100 μικρογραμμ?ρια/ml πυκν? δι?λυμα για

παρασκευ? διαλ?ματος προς ?γχυση

Ireland: Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Italy: Dexmedetomidina Baxter

Norway: Dexmedetomidine Baxter 100 mikrogram/ml konsentrat til infusjonsvæske,

oppløsning

Portugal: Dexmedetomidina Baxter

Spain: Dexmedetomidina Baxter 100 μg/ml concentrado para solución para perfusión EFG

Sweden: Dexmedetomidine Baxter

Cyprus: Dexmedetomidine/Baxter 100 μικρογραμμ?ρια/ml πυκν? δι?λυμα για

παρασκευ? διαλ?ματος προς ?γχυση

Luxembourg: Dexmedetomidine Baxter 100 microgrammes/ml, solution à diluer pour perfusion

United Kingdom: Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Date of last revision of this leaflet:June 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Dexmedetomidine Baxter 100 micrograms/ml Concentrate for Solution for Infusion EFG

Route of administration

This medicine should be administered by healthcare professionals trained in the management of patients requiring intensive care or in the management of anesthesia in patients in the operating room. It should be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

This medicine can be diluted in glucose 50 mg/ml (5%), Ringer's Lactate solution, mannitol 200 mg/ml (20%) or sodium chloride 9 mg/ml (0.9%) injectable solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See the table below for the volumes needed to prepare the infusion.

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

Volume of dexmedetomidine 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 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.

This medicine should be visually inspected for particles and coloration before administration.

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

Ringer's Lactate, glucose 5% solution, sodium chloride 9 mg/ml (0.9%) injectable solution, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate and a plasma substitute.

Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber. Although dexmedetomidine is dosed to effect, it is recommended to use components with synthetic or natural rubber seals.

Shelf life

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, unless the dilution method excludes the risk of microbiological contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Do not refrigerate.

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

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

5.0 (5)
Doctor

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.

Key areas of expertise:

  • Addiction treatment: alcohol and drug dependence, gambling addiction, compulsive behaviours, codependent relationships.
  • Support for families of addicted individuals, behavioural correction within the family system, guidance for maintaining remission.
  • Mental health: depression, bipolar disorder, obsessive-compulsive disorder (OCD), anxiety disorders, phobias, PTSD, generalised anxiety, emotional trauma, and the psychological impact of loss or emigration.
  • Psychoeducation: explaining complex mental health concepts in simple language, helping patients and their families understand diagnoses and treatment steps.
Therapeutic approach:
  • Client-centred, straightforward, and empathetic – focused on practical outcomes and emotional stabilisation.
  • Prescribes medications when needed, but always aims to minimise unnecessary pharmaceutical use.
  • Certified in multiple evidence-based methods: CBT, NLP (Master Practitioner), Ericksonian hypnosis, symbol drama, art therapy, and systemic therapy.
  • Each consultation results in a clear, structured plan – patients leave knowing exactly what to do next.
Experience and background:
  • Member of the German association Gesundheitpraktikerin and the NGO “Mit dem Sonne in jedem Herzen.”
  • More than 18 publications in international peer-reviewed journals, translated into several languages.
  • Volunteer work with Ukrainian refugees and military personnel at the University Clinic of Regensburg.
Camera Book a video appointment
€130
5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

Camera Book a video appointment
€55
0.0 (1)
Doctor

Daria Portnova

Psychiatry 31 years exp.

Dr Daria Portnova is a psychiatrist and psychotherapist with over 30 years of clinical experience. She works with adults and adolescents aged 14 and over, providing online psychiatric and psychotherapeutic consultations.

In her practice, Dr Portnova supports patients facing the onset of mental health conditions, chronic psychiatric disorders, psychotic symptoms, trauma-related states, and complex emotional crises. Her work is structured and safety-focused, with an emphasis on stabilisation, accurate diagnosis, and long-term improvement in quality of life.

Patients consult Dr Daria Portnova for the following concerns:

  • existential crises and complex life situations;
  • loss, grief, and emotional exhaustion;
  • relationship difficulties, separation, and divorce;
  • psychological and psychiatric trauma, including complex PTSD (cPTSD);
  • anxiety disorders: generalised anxiety disorder and panic disorder;
  • social anxiety and social phobia;
  • obsessive-compulsive disorder (OCD);
  • sleep disorders;
  • depressive disorders;
  • bipolar affective disorder;
  • schizoaffective disorder;
  • schizophrenia;
  • personality disorders.
Dr Portnova combines psychiatric assessment with a psychotherapeutic approach. She works with evidence-based methods, including cognitive behavioural therapy (CBT) and third-wave approaches such as ACT, FACT, and CFT. Consultations are focused on clear clinical understanding, practical recommendations, and ongoing support over time.
Camera Book a video appointment
€110
5.0 (77)
Doctor

Sergey Ilyasov

Psychiatry 7 years exp.

Dr Sergey Ilyasov is an experienced neurologist and qualified psychiatrist who provides online consultations for adults and adolescents. Combining deep neurological expertise with a modern psychiatric approach, he ensures comprehensive diagnostics and effective treatment for a wide range of conditions affecting both physical and mental health.

Dr. Ilyasov helps patients in the following cases:

  • Chronic headaches (migraine, tension-type headache), back pain, neuropathic pain, dizziness, numbness in limbs, coordination disorders.
  • Anxiety disorders (panic attacks, generalized anxiety disorder), depression (including atypical and treatment-resistant forms), sleep disturbances (insomnia, hypersomnia, nightmares), stress, burnout.
  • Chronic pain syndromes and psychosomatic symptoms (e.g., irritable bowel syndrome related to stress, vegetative-vascular dystonia).
  • Behavioral disorders and concentration difficulties in adolescents (including ADHD, autism spectrum disorders), nervous tics.
  • Memory impairments, phobias, obsessive-compulsive disorder (OCD), emotional swings, and support for post-traumatic stress disorder (PTSD).

Thanks to his dual specialization in neurology and psychiatry, Dr Sergey Ilyasov offers integrated and evidence-based care for complex conditions requiring a multidisciplinary approach. His consultations focus on accurate diagnosis, development of an individualized treatment plan (including pharmacotherapy and psychotherapeutic methods), and long-term support adapted to each patient's unique needs.

Book an online consultation with Dr. Sergey Ilyasov to receive qualified assistance and improve your well-being today.

Camera Book a video appointment
€89
5.0 (137)
Doctor

Taisiia Proida

Psychiatry 7 years exp.

Dr. Taisiia Proida is a psychiatrist and cognitive behavioural therapist (CBT), and a member of the European Psychiatric Association. She offers online consultations for adults aged 18 and over, combining evidence-based medicine with an individualised approach to mental health care.

She specialises in consultations and ongoing support for a wide range of mental health concerns, including:

  • Mood disorders: depression, bipolar disorder, postpartum depression.
  • Anxiety disorders: generalised anxiety, OCD, panic attacks, phobias.
  • Post-traumatic stress disorder (PTSD) and complex PTSD.
  • Attention deficit hyperactivity disorder (ADHD) and autism spectrum disorder (ASD). Assessment is provided only after an initial psychiatric evaluation and during a follow-up appointment.
  • Personality disorders and emotional instability.
  • Cyclothymia and mood fluctuations.
  • Schizophrenia spectrum and related conditions.

Dr. Proida combines clinical expertise with an empathetic approach, offering structured support based on evidence-based practices. Her work integrates CBT techniques with medical management, with a focus on anxiety and depressive disorders.

She works with clients from different countries and cultural backgrounds, adapting her communication style and recommendations to individual needs. With experience in international clinical trials (Pfizer, Merck), she values clarity, trust, and collaborative partnership in patient care.

Camera Book a video appointment
€120
5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

Camera Book a video appointment
€55

Frequently Asked Questions

Is a prescription required for DEXMEDETOMIDINE BAXTER 100 micrograms/ml concentrate for infusion solution?
DEXMEDETOMIDINE BAXTER 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 BAXTER 100 micrograms/ml concentrate for infusion solution?
The active ingredient in DEXMEDETOMIDINE BAXTER 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 BAXTER 100 micrograms/ml concentrate for infusion solution?
DEXMEDETOMIDINE BAXTER 100 micrograms/ml concentrate for infusion solution is manufactured by Baxter Holding B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DEXMEDETOMIDINE BAXTER 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 BAXTER 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 BAXTER 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.
bg-pattern-dark

Stay informed about Oladoctor

News about new services, product updates and useful information for patients.

Follow us on social media