What it is and what it is used for

for

Dexmedetomidine contains an active substance called dexmedetomidine which belongs to a medicine group called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.

Pregnancy and breast-feeding

Dexmedetomidine has major impact on the ability to drive and use machines. After you have been given Dexmedetomidine you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.

How to take it

Dexmedetomidine

2.
What you need to know before you are given Dexmedetomidine You must not be given Dexmedetomidine

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  if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
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  if you have some disorders of heart rhythm (heart block grade 2 or 3).
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  if you have very low blood pressure which does not respond to treatment.
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  if you have recently had a stroke or other serious condition affecting blood supply to the
  brain. Warnings and precautions Before you have this medicine, tell your doctor or nurse if any of the following apply as Dexmedetomidine should be used cautiously:
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  if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness) as it may increase the risk for cardiac arrest
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  if you have low blood pressure
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  if you have low blood volume, for example after bleeding
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  if you have certain heart disorders
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  if you are elderly
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  if you have a neurological disorder (for instance head or spinal cord injury or stroke)
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  if you have severe liver problems
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  if you have ever developed a serious fever after some medicines, especially anaesthetics This medicine may cause large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information. An increased mortality risk has been seen for patients 65 years of age and under when using this medicine, especially for patients admitted to the intensive care unit for other reasons than after surgery with a more severe disease condition on admission to the intensive care unit and with a younger age. The doctor will decide if this medicine is still suitable for you. The doctor will take into account the benefit and risks of this medicine for you, compared to treatment with other sedatives. The following information is intended for healthcare professionals only: Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion Method of administration Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion should be administered by healthcare professionals skilled in the management of patients requiring intensive care or in the anaesthetic management of patients in the operating room. It must be administered only as a diluted intravenous infusion using a controlled infusion device. Preparation of solution Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion can be diluted in glucose 50 mg/ml (5%), lactated ringers, mannitol 200 mg/ml (20%) or sodium chloride 9 mg/ml (0.9%) solution for injection to achieve the required concentration of either 4 micrograms/ml or 8 micrograms/ml prior to administration. Please see below in tabulated form the volumes needed to prepare the infusion.

Hospital intensive care Dexmedetomidine is administered to you by a doctor or nurse in hospital intensive care. Procedural sedation/awake sedation Dexmedetomidine is administered to you by a doctor or a nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation. Your doctor will decide on a suitable dose for you. The amount of Dexmedetomidine depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment. Dexmedetomidine is diluted and it is given to you as an infusion (drip) into your veins. After sedation/wake-up

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  The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
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  You should not go home unaccompanied.
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  Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexmedetomidine. Talk to your doctor about the use of these medicines and about the use of alcohol. If you have been given more Dexmedetomidine than you should If you are given too much Dexmedetomidine, your blood pressure may go up or down, your heartbeat 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 further questions on the use of this medicine, ask your doctor. 4.
  Possible side effects Like all medicines, this medicine can cause

Possible side effects

, although not everybody gets them. In case the required concentration is 4 micrograms/ml: Volume of Volume Total Dexmedetomidine of volume 100 micrograms/ml diluent of concentrate for infusion solution for 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 the required concentration is 8 micrograms/ml: Volume of Volume Total Dexmedetomidine of volume 100 micrograms/ml diluent of concentrate for infusion solution for 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 shaken gently to mix well.

Common (affects 1 to 10 users in 100)

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  chest pain or heart attack
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  fast heart rate
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  low or high blood sugar
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  nausea, vomiting or dry mouth
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  restlessness
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  high temperature
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  symptoms after stopping the medicine Uncommon (affects 1 to 10 users in 1,000)
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  reduced heart function, cardiac arrest
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  swelling of the stomach
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  thirst
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  a condition where there is too much acid in the body
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  low albumin level in blood
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  shortness of breath
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  hallucinations
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  the medicine is not effective enough. Not known (frequency cannot be estimated from the available data)
• large amount of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if these occur Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance Website: www.hpra.ie United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 5.
  How to store Dexmedetomidine 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 temperature storage conditions. After dilution Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, unless the method of dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user. Do not refrigerate. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
  Contents of the pack and other information What Dexmedetomidine contains
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  The a ctive substance is dexmedetomidine. Each ml of concen trate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
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  Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).

What Dexmedetomidine looks like and contents of the pack Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear, colourless solution. Container 2 ml glass vials Pack size 5 x 2 ml vials Marketing Authorisation Holder Ireland Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Manufacturer UAB Norameda Meistru 8a, Vilnius, 02189, Lithuania Bieffe Medital S.p.A Via Nuova Provinciale 23034 Grosotto (SO) Italy This medicinal product is authorised in the Member States of the EEA under the following names: Netherlands Dexmedetomidine Baxter 100 microgram/ml concentraat voor oplossing voor infusie Dexmedetomidin Baxter 100 Austria Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung Dexmedetomidine Baxter Belgium 100 microgrammes/ml solution à diluer pour perfusion Dexmedetomidine Baxter Denmark Dexmedetomidine Baxter Finland 100 mikrog/ml infuusiokonsentraatti, liuosta varten Germany Dexmedetomidin Baxter 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung Dexmedetomidine/Baxter Greece 100 μg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση Ireland Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion Dexmedetomidine Baxter Norway Portugal Dexmedetomidina Baxter Spain Dexmedetomidina Baxter 100 microgramos/ml Concentrado para solución para perfusión EFG Dexmedetomidine Baxter Sweden Dexmedetomidine/Baxter Cyprus 100 μg/ml πυκνό διάλυμα για παρασκευή διαλύματος προς έγχυση Luxembourg Dexmedetomidine Baxter 100 microgrammes/ml, solution à diluer pour perfusion Dexmedetomidine 100 United micrograms/ml concentrate Kingdom for solution for infusion

1400008288

Very common (affects more than 1 user in 10)

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

This leaflet was last revised in 04/2024

The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml. The other ingredients are sodium chloride and water for injections Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion should be inspected visually for particulate matter and discoloration prior to administration. Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion has been shown to be compatible when administered with the following intravenous fluids and medicinal products: Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, 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 advisable to use components with synthetic

or coated natural rubber gaskets. Shelf life Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C. From a microbiological point of view, unless the method of dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user. Do not refrigerate.