Dexdor
dexmedetomidine
dexmedetomidine
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. This includes any possible side effects not listed in this leaflet. See section 4.
What Dexdor is and what it is used for
What you need to know before you are given Dexdor
How to use Dexdor
Possible side effects
How to store Dexdor
Contents of the pack and other information
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.
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.
Beforeyouhavethismedicine,tellyourdoctorornurseifanyofthefollowingapplyasDexdor shouldbeusedcautiously:
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.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. ThefollowingmedicinesmayenhancetheeffectofDexdor:
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.
Dexdor should not be used during pregnancy or breast-feeding unless clearly necessary. Ask your doctor for advice before having this medicine
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.
Dexdor contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
Dexdor is administered to you by a doctor or nurse in hospital intensive care.
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.
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 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. Verycommon (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.
Notknown (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.
Reportingofsideeffects
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 thenationalreportingsystemlistedin 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.
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.
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
Packsizes
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.
Orion Corporation
Orionintie 1
FI-02200 Espoo Finland
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:
Orion Pharma BVBA/SPRL Tel: +32 (0)15 64 10 20
Orion Pharma A/S Tlf: +45 8614 00 00
Orion Pharma Eesti Oü Tel: +372 6 644 550
Orion Pharma GmbH Tel: + 49 40 899 6890
Orion Pharma S.L.
Tel: + 34 91 599 86 01
Orion Pharma Hellas M.E.Π.E Τηλ: + 30 210 980 3355
Orion Pharma (Ireland) Ltd. Tel: + 353 1 428 7777
Orion Pharma
Tél: +33 (0) 1 85 18 00 00
Orion Pharma S.r.l. Tel: + 39 02 67876111
Vistor hf.
Simi: +354 535 7000
Orion Corporation
Orion Pharma pārstāvniecība Tel: +371 20028332
Lifepharma (ZAM) Ltd Τηλ.: +357 22056300
UAB Orion Pharma Tel: +370 5 276 9499
Orion Pharma Poland Sp. z.o.o. Tel.: + 48 22 8 333 177
Orion Pharma AS Tlf: + 47 4000 4210
Orion Pharma d.o.o.
Tel: +386 (0) 1 600 8015
Orionfin Unipessoal Lda Tel: + 351 21 154 68 20
Orion Corporation Puh/Tel: + 358 10 4261
Orion Pharma Poland Sp. z.o.o.
PHOENIX Farmacija d.o.o.
Тел.: + 48 22 8 333 177 Tel: +385 1 6370450
Orion Corporation
Tel: + 358 10 4261
Orion Corporation
Tel: + 358 10 4261
Orion Pharma (Ireland) Ltd. Tel: +353 1 428 7777
Orion Pharma AB Tel: + 46 8 623 6440
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The following information is intended for healthcare professionals only:
Methodofadministration
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.
Inthecasetherequiredconcentrationis4micrograms/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 |
Inthecasetherequiredconcentrationis8micrograms/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. Dexdorhasbeenshowntobecompatiblewhenadministeredwiththefollowingintravenousfluidsand
medicinalproducts:
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.
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.