Leaflet: information for the user

Dexdor 100micrograms/mL concentrate for solution for infusion

dexmedetomidine

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

1. What is Dexdor and what it is used for

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

3. How to use Dexdor

4. Possible side effects

5. Storage of Dexdor

6. Contents of the pack and additional information

Dexdor contains an active substance called dexmedetomidine, which belongs to a group of medications called sedatives. It is used to provide sedation (a state of calmness, drowsiness, or sleep) in adult patients in intensive care units of hospitals or conscious sedation during various diagnostic or surgical procedures.

Do not administer Dexdor

• if you are allergic to dexmedetomidine or any of the other components of this medication (listed in section 6)
• if you have some 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 medication, inform 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 illness or high physical condition level)as it may increase the risk of cardiac arrest
• if you have low blood pressure
• if you have low blood volume, for example after a hemorrhage
• if you have certain heart diseases
• if you are elderly
• if you have a neurological disorder (for example, head or spinal cord injuries or stroke)
• if you have severe liver disease
• if you have ever developed a severe fever after some medications, especially anesthetics

Use of Dexdor with other medications

Inform your doctor or nurse if you are using, have used recentlyor may need to use any other medication.

The following medications may increase the effect of Dexdor:

• medications that help you sleep or cause sedation (e.g., midazolam, propofol)
• strong pain medications (e.g., opioids such as morphine, codeine)
• anesthetics (e.g., sevoflurane, isoflurane)

If you are using medications that lower your blood pressure and heart rate, the concurrent administration with Dexdor may increase this effect.Dexdor should not be used with medications that can cause temporary paralysis.

Pregnancy and breastfeeding

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

Consult your doctor beforeusing thismedication.

Driving and operating machines

Dexdor has a significant impact on your ability to drive and operate machines.Once Dexdor has been administered, do not drive, operate machines, or work in hazardous situations until the effects have completely passed.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”.

Intensive Care Hospital Care

Dexdor is administered by a doctor or nurse in the intensive care unit of a hospital.

Procedure Sedation / Conscious Sedation

A doctor or nurse will administer Dexdor before and/or during diagnostic or surgical procedures that require sedation, e.g. procedure sedation / conscious sedation.

Your doctor will decide on the appropriate dose for you. The amount of Dexdor depends on your age, body weight, overall health, the level of sedation required, and how you respond to the medication. Your doctor may change your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexdor is diluted and administered as an infusion (drip) into your veins.

After Sedation/Waking Up

• Your doctor will keep you under supervision for several hours after sedation to ensure you are okay.
• You should not go home unless accompanied.
• Medications that help you sleep can cause sedation, and those intended to relieve intense pain may not be recommended for a period of time after treatment with Dexdor. Consult with your doctor about the use of these medications and alcohol use.

If You Have Been Given MoreDexdorThan You Should

If you have been given too much Dexdor, your blood pressure may rise or fall, your heart rate 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 medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very frequent (affects more than 1 in 10 users)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or cessation of breathing.

Frequent (affects between 1 and 10 in 100 users)

• chest pain or heart attack
• rapid heart rate
• low or high blood sugar levels
• nausea, vomiting, or dry mouth
• restlessness
• high temperature
• symptoms after stopping the medication.

Rare (affects between 1 and 10 in 1,000 users)

• decreased heart function , cardiac arrest
• gastric distension
• thirst
• a condition in which there is too much acid in the body
• low albumin levels in the blood
• difficulty breathing
• hallucinations
• the medication is not effective enough.

Unknown frequency ( cannot be estimated from available data)

• urinating frequently.

Reporting Adverse Effects

If you experience adverse effects, consult your doctor or nurse, even if they are possible adverse effects that do not appear in this prospectus. You can also report them directly through the national notification system included in the Appendix V . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and packaging after CAD.

This medication does not require any special storage temperature. Storeampoules or vials in the outer packaging to protect it from light.

Composition of Dexdor

• The active principle is dexmedetomidine. Each ml of concentrate contains hydrochloride of dexmedetomidine equivalent to 100micrograms of dexmedetomidine.
• The other components are sodium chloride and water for injection.

Each ampoule of 2ml contains 200micrograms of dexmedetomidine (as hydrochloride).

Each vial of 2ml contains 200micrograms of dexmedetomidine (as hydrochloride).

Each vial of 4ml contains 400micrograms of dexmedetomidine (as hydrochloride).

Each vial of 10ml contains 1000micrograms of dexmedetomidine (as hydrochloride).

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

Aspect of the productand contents of the packaging

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a transparent and colorless solution.

Containers

2 ml glass ampoules

2, 5 or 10 ml glass vials

Pack sizes

5 ampoules with 2ml

25 ampoules with 2ml

5 vials with 2ml

4 vials with 4ml

4 vials with 10ml

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Responsible for manufacturing

Orion CorporationOrion Pharma

Orionintie 1

FI-02200Espoo

Finland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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

This information is intended for healthcare professionals only:

Dexdor 100microgramos/ml concentrate for solution for infusion

Administration route

Dexdor should be administered by healthcare professionals experienced in the care 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

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

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

In case a concentration of 8microgramos/ml is required:

The solution should be gently agitated to mix well.

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

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

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

Compatibility studies have shown potential for dexmedetomidine to adsorb to some types of natural rubber. Although dexmedetomidine is dosed based on effect, it is recommended to use components with synthetic or coated natural rubber joints.

Expiry date

Chemical and physical stability has been demonstrated in use for 24 hours at25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally be greater than 24 hours between2° and8°C,unless the dilution has been prepared in controlled and validated aseptic conditions.