Dexmedetomidine 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, pharmacist 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 is Dexmedetomidine and what it is used for
2. What you need to know before you are given Dexmedetomidine
3. How to use Dexmedetomidine
4. Possible side effects
5. How to store Dexmedetomidine
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 are given this medicine, tell your doctor or nurse if any of the following apply as Dexmedetomidine 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 risk of mortality has been observed in patients 65 years of age and younger when using this medication, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe illness on admission to the care unit intensive and with a younger age. The doctor will decide if this medicine is still suitable for you. The doctor will consider the benefits and risks of this medicine for you, in comparison with treatment with other sedatives.

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 Dexmedetomidine

• 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 Dexmedetomidine may enhance this effect. Dexmedetomidine should not be used with medicines that cause temporary paralysis.

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

Ask your doctor or pharmacist for advice before taking this medicine.

Dexmedetomidine has major impact on the ability to drive and use machines.

After you have been given Dexmedetomidine you must not drive, operate machinery, or work in dangerous situations. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.

This medicine contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially `sodium-free´.

This medicine contains 37 mg sodium (main component of cooking/table salt) in each 10 mL vial. This is equivalent to 2 % of the recommended maximum daily dietary intake of sodium for an adult.

Dexmedetomidine is administered to you by a doctor or nurse in hospital intensive care.

Dexmedetomidine is administered to you by a doctor or 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 Dexmedetomidine 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.

Dexmedetomidine 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 Dexmedetomidine. Talk to your doctor about the use of these medicines and about the use of alcohol.

If you are given too much Dexmedetomidine, 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, pharmacist 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 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 of Dexmedetomidine.

The other ingredients are sodium chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment) and water for injections.

Each 2 mL ampoule 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

6 or 10 mL glass vials

Pack sizes

5 x 2 mL ampoules

25 x 2 mL ampoules

4 x 4 mL vials

4 x 10 mL vials

Not all pack sizes may be marketed.