Dexdor 100 micrograms/ml concentrate for solution for infusion

• 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.

1. What Dexdor is 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. How to store Dexdor
6. Contents of the pack and other information

• 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.

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.

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.

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 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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

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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: