DEXDOR 100 micrograms/ml concentrate for infusion solution

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.

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.

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:

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.

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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:

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

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.