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DEXDOR 100 micrograms/ml concentrate for infusion solution

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About the medicine

How to use DEXDOR 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

Dexdor 100micrograms/ml concentrate for solution for infusion

dexmedetomidine

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 and other information:

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

1. What is Dexdor and what is it used for

Dexdor 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.

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2. What you need to know before you are given Dexdor

Dexdor 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 Dexdor 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

Using Dexdor with other medicines

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 Dexdor:

  • 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 Dexdor may increase this effect. Dexdor should not be used with medicines that can cause temporary paralysis.

Pregnancy and breast-feeding

Dexdor should not be used during pregnancy or breast-feeding, unless clearly necessary.

Ask your doctor before using this medicine.

Driving and using machines

Dexdor has a major impact on your ability to drive and use machines. Once you have been given Dexdor, 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.

Excipients

Dexdor contains less than 1 mmol of sodium (23 mg) per ml; this is essentially “sodium-free”.

3. How Dexdor is used

Intensive care in hospital

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

Procedural sedation / conscious sedation

Dexdor 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 Dexdor 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.

Dexdor 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 some 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 Dexdor. Consult your doctor about the use of these types of medicines and about the use of alcohol.

If you have been given too much Dexdor

If you have been given too much Dexdor, your blood pressure may go up or down, your heart beats may be slower, 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.

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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 stop breathing.

Common (affect between 1 and 10 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 and 10 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.

Rare (cannot be estimated from the available data)

  • frequent urination.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are 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.

5. Storage of Dexdor

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 conditions. Store the ampoules or vials in the outer packaging to protect from light.

6. Contents of the pack and further information

Composition of Dexdor

  • 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 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 4 micrograms/ml or 8 micrograms/ml.

Appearance and pack size

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution

Pack sizes

2 ml glass ampoules

2, 5 or 10 ml glass vials

Pack sizes

5 ampoules of 2 ml

25 ampoules of 2 ml

5 vials of 2 ml

4 vials of 4 ml

4 vials of 10 ml

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

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

België/Belgique/Belgien

Luxembourg/Luxemburg

Orion Pharma BVBA/SPRL

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 00 00

Ceská 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

Centre Spécialités Pharmaceutiques

Tel: + 33 (0) 1 47 04 80 46

Italia

Orion Pharma S.r.l.

Tel: + 39 02 67876111

Ísland

Vistor hf.

Simi: +354 535 7000

Latvija

Orion Corporation in Latvia

Tel: + 371 6745 5569

Κύπρος

Lifepharma (ZAM) Ltd

Τηλ.: +357 22347440

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

??????

Orion Pharma Poland Sp. z.o.o.

???.: + 48 22 8 333 177

Hrvatska

PHOENIX Farmacija d.o.o.

Tel: +385 1 6370450

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

United Kingdom

Orion Pharma (UK) Ltd.

Tel: + 44 1635 520 300

Sverige

Orion Pharma AB

Tel: + 46 8 623 6440

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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

This information is intended only for healthcare professionals:

Dexdor 100micrograms/ml concentrate for solution for infusion

Method of administration

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

Preparation of the solution

Dexdor can be diluted in glucose 50 mg/ml (5%), Ringer’s solution, mannitol or sodium chloride 9 mg/ml (0.9%) injection solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See below in the form of a table the volumes needed to prepare the infusion.

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

Volume of Dexdor 100micrograms/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 8micrograms/ml is required:

Volume of Dexdor 100micrograms/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.

Dexdor should be visually inspected for particles and coloration before administration.

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

Ringer’s solution, glucose 5% solution, sodium chloride 9 mg/ml (0.9%) injection solution, mannitol 200 mg/ml (20%), 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.

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 gaskets.

Shelf life

Chemical and physical stability in use 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 are the responsibility of the user and would normally not be longer than 24 hours at 2° to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

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Frequently Asked Questions

Is a prescription required for DEXDOR 100 micrograms/ml concentrate for infusion solution?
DEXDOR 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 DEXDOR 100 micrograms/ml concentrate for infusion solution?
The active ingredient in DEXDOR 100 micrograms/ml concentrate for infusion solution is dexmedetomidine. This information helps identify medicines with the same composition but different brand names.
Who manufactures DEXDOR 100 micrograms/ml concentrate for infusion solution?
DEXDOR 100 micrograms/ml concentrate for infusion solution is manufactured by Orion Corporation. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DEXDOR 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 DEXDOR 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 DEXDOR 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, DEXMEDETOMIDINE ALTAN 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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