dexmedetomidine: package leaflet

Dexdor 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.

You must not be given Dexdor
- if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6)
- if you have some disorders of heart rhythm (heart block grade 2 or 3)
- if you have very low blood pressure which does not respond to treatment
- 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 Dexdor should be used cautiously:
- 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
- if you have low blood pressure
- if you have low blood volume, for example after bleeding
- if you have certain heart disorders
- if you are elderly
- if you have a neurological disorder (for instance head or spinal cord injury or stroke)
- if you have severe liver problems
- 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.
Other medicines and Dexdor
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
The following medicines may enhance the effect of Dexdor:
- medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
- strong pain medicines (e.g. opioids such as morphine, codeine)
- anaesthetic medicines (e.g. sevoflurane, isoflurane).
If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexdor may enhance this effect. Dexdor should not be used with medicines that cause temporary paralysis.
Pregnancy and breast-feeding
Dexdor should not be used during pregnancy or breast-feeding unless clearly necessary.
Ask your doctor for advice before having this medicine
Driving and using machines
Dexdor has major impact on the ability to drive and use machines. After you have been given Dexdor 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.
Excipients
Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

Hospital intensive care
Dexdor is administered to you by a doctor or nurse in hospital intensive care.
Procedural sedation/awake sedation
Dexdor 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 Dexdor 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.
Dexdor is diluted and it is given to you as an infusion (drip) into your veins.
After sedation/wake-up
- The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.

- You should not go home unaccompanied.
- Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexdor. Talk to your doctor about the use of these medicines and about the use of alcohol.
If you have been given more Dexdor than you should
If you are given too much Dexdor, 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.

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
- 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
- swelling of the stomach
- thirst
- a condition where there is too much acid in the body
- low albumin level in blood
- shortness of breath
- hallucinations
- 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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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. Keep the ampoules or vials in the outer carton in order to protect from light.

What Dexdor contains
- The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms dexmedetomidine.
- The other ingredients are sodium chloride and water for injections.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).
Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).
The concentration of the final solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.
What Dexdor looks like and contents of the pack
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution.
Containers
2 ml glass ampoules
2, 5 or 10 ml glass vials
Pack sizes
5 x 2 ml ampoules
25 x 2 ml ampoules
5 x 2 ml vials
4 x 4 ml vials
4 x 10 ml vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Orion Pharma BVBA/SPRL
Tél/Tel: +32 (0)15 64 10 20
Nederland
Orion Pharma BVBA/SPRL
Tel: +32 (0)15 64 10 20
Danmark
Orion Pharma A/S
Tlf.: +45 8614 0000
Česká republika
Orion Pharma s.r.o.
Tel: +420 234 703 305
Eesti
Orion Pharma Eesti Oü
Tel: +372 6 644 550
Deutschland
Österreich
Orion Pharma GmbH
Tel: + 49 40 899 6890
España
Orion Pharma S.L.
Tel: + 34 91 599 86 01
Ελλάδα
Orion Pharma Hellas M.E.Π.E
Τηλ: + 30 210 980 3355
Ireland
Orion Pharma (Ireland) Ltd.
Tel: + 353 1 428 7777
France
Orion Pharma
Tél: +33 (0) 1 85 18 00 00
Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111
Ísland
Vistor hf.
Simi: +354 535 7000
Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Tel: +371 20028332
Κύπρος
Lifepharma (ZAM) Ltd
Τηλ.: +357 22056300
Magyarország
Orion Pharma Kft.
Tel.: +36 1 239 9095
Lietuva
UAB Orion Pharma
Tel: +370 5 276 9499
Polska
Orion Pharma Poland Sp. z.o.o.
Tel.: + 48 22 8 333 177
Norge
Orion Pharma AS
Tlf: + 47 4000 4210
Slovenija
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015
Portugal
Orionfin Unipessoal Lda
Tel: + 351 21 154 68 20
Suomi/Finland
Orion Corporation
Puh/Tel: + 358 10 4261
България
Orion Pharma Poland Sp. z.o.o.
Тел.: + 48 22 8 333 177
Hrvatska
PHOENIX Farmacija d.o.o.
Tel: +385 1 3650 138
Malta
Orion Corporation
Tel: + 358 10 4261
România
Orion Corporation
Tel: + 358 10 4261

Slovenská republika
Orion Pharma s.r.o.
Tel: +420 234 703 305
Sverige
Orion Pharma AB
Tel: + 46 8 623 6440
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu
-------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only:
Dexdor 100 micrograms/ml concentrate for solution for infusion
Method of administration
Dexdor 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
Dexdor can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol 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.
In the case the required concentration is 4 micrograms/ml:
Volume of Dexdor
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 the case the required concentration is 8 micrograms/ml:
Volume of Dexdor
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 shaken gently to mix well.
Dexdor should be inspected visually for particulate matter and discoloration prior to administration.
Dexdor 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, 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 and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.