What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 46654/0005 .


Dexmedetomidine EVER Pharma 100 micrograms/ml Concentrate for Solution for Infusion

Package leaflet: Information for the user

Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion

Dexmedetomidine

Read all of this leaflet carefully before you are given 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Dexmedetomidine EVER Pharma is and what it is used for
2. What you need to know before you are given Dexmedetomidine EVER Pharma
3. How Dexmedetomidine EVER Pharma will be given
4. Possible side effects
5. How to store Dexmedetomidine EVER Pharma
6. Contents of the pack and other information

1. What Dexmedetomidine EVER Pharma is and what it is used for

Dexmedetomidine EVER Pharma 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.

2. What you need to know before you are given Dexmedetomidine EVER Pharma

You must not be given Dexmedetomidine EVER Pharma:

  • 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.

Warnings and precautions

Before you are given this medicine, tell your doctor or nurse if any of the following apply as Dexmedetomidine EVER Pharma 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 anesthetics

Other medicines and Dexmedetomidine EVER Pharma

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 EVER Pharma:

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

If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexmedetomidine EVER Pharma may enhance this effect. Dexmedetomidine EVER Pharma should not be used with medicines that cause temporary paralysis.

Pregnancy and breast-feeding

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

Ask your doctor for advice before having this medicine.

Driving and using machines

Dexmedetomidine EVER Pharma has major impact on the ability to drive and use machines. After you have been given Dexmedetomidine EVER Pharma 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.

Dexmedetomidine EVER Pharma contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.

3. How Dexmedetomidine EVER Pharma will be given

Hospital intensive care

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

Procedural sedation/awake sedation

Dexmedetomidine EVER Pharma 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 EVER Pharma 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 EVER Pharma is diluted and it is given to you as an infusion (drip) into your veins.

After sedation/wake-up

  • 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 EVER Pharma. Talk to your doctor about the use of these medicines and about the use of alcohol.

If you have been given more Dexmedetomidine EVER Pharma than you should

If you are given too much Dexmedetomidine EVER Pharma, 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (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
  • symptoms after stopping the medicine
  • high temperature

Uncommon (may affect up to 1 in 100 people)

  • a condition where there is too much acid in the body
  • low albumin level in blood
  • hallucinations
  • reduced heart function, cardiac arrest
  • shortness of breath and transient cessation of respiration
  • the medicine is not effective enough.
  • swelling of the stomach
  • thirst

Not known (frequency cannot be estimated from available data)

  • increased need to pass urine

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist 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). By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dexmedetomidine EVER Pharma

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.

6. Contents of the pack and other information

What Dexmedetomidine EVER Pharma contains

  • 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 4 ml ampoule contains 400 micrograms of dexmedetomidine (as hydrochloride).

Each 10 ml ampoule contains 1000 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.

What Dexmedetomidine EVER Pharma looks like and contents of the pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless solution.

Containers

2, 5 or 10 ml colourless glass ampoules

2, 5 or 10 ml colourless glass vials

Pack sizes

5 x 2 ml ampoules

25 x 2 ml ampoules

4 x 4 ml ampoules

5 x 4 ml ampoules

4 x 10 ml ampoules

5 x 10 ml ampoules

5 x 2 ml vials

4 x 4 ml vials

5 x 4 ml vials

4 x 10 ml vials

5 x 10 ml vials

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer:

EVER Pharma Jena GmbH
Otto-Schott-Strasse 15
07745 Jena
Germany

This leaflet was last revised in 03/2020