Dexdor 100 micrograms/ml concentrate for solution for infusion (25x2 ml)

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexdor 100 micrograms/ml concentrate for solution for infusion

dexmedetomidine

Read the entire 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, ask your doctor or nurse.
• If you experience any adverse reactions, consult your doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Dexdor is and what it is used for
2. What you need to know before Dexdor is administered to you
3. How to use Dexdor
4. Possible side effects
5. How to store Dexdor
6. Contents of the pack and other information

1. What Dexdor is and what it is used for

Dexdor contains an active substance called 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 hospital intensive care units or conscious sedation during various diagnostic or surgical procedures.

2. What you need to know before Dexdor is administered to you

Dexdor must not be given to you if

• you are allergic to dexmedetomidine or to any of the other ingredients of this medicine (listed in section 6).
• you have certain heart rhythm disorders (second- or third-degree atrioventricular block).
• you have very low blood pressure that does not respond to treatment.
• you have recently had a stroke or other serious episodes affecting blood supply to the brain.

Warnings and precautions

Before this medicine is used, inform your doctor or nurse if any of the following apply to you, as Dexdor should be used with caution:

• if you have abnormally slow heart rate (either due to illness or due to high physical fitness), as this 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 taking certain medicines, especially anesthetics

Use of Dexdor with other medicines

Tell your doctor or nurse if you are taking, have recently taken, or might need to take any other medicines.

The following medicines may increase the effect of Dexdor:

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

If you are taking medicines that lower your blood pressure and heart rate, using them together with Dexdor may increase this effect. Dexdor must not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

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

Consult your doctor before using this medicine.

Driving and using machines

Dexdor has a major impact on the ability to drive and use machines. After receiving Dexdor, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Consult your doctor on when you may resume these activities and types of work.

Excipients

Dexdor contains less than 1 mmol of sodium (23 mg) per ml; this is essentially "sodium-free".

3. How to use Dexdor

Hospital intensive care

Dexdor will be administered to you by a doctor or nurse in the intensive care unit of a hospital.

Procedural sedation / conscious sedation

Dexdor is administered by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, e.g. procedural sedation / conscious sedation.

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

Dexdor is diluted and administered to you as an intravenous infusion (drip).

After sedation / recovery

• Your doctor will keep you under supervision for several hours after sedation to ensure that you are well.
• You must not go home unaccompanied.
• Medicines that help you sleep, sedatives, or those used to relieve severe pain may not be recommended for a period of time after treatment with Dexdor. Consult your doctor regarding the use of these medicines and regarding alcohol consumption.

If you have been given more Dexdor than you should

If you have been given too much Dexdor, your blood pressure may increase or decrease, your heart rate may become slower, your breathing may slow down, and you may feel excessively drowsy. Your doctor will know how to treat you based on your condition.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common (affect more than 1 in 10 users)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or breathing stoppage

Common (affect between 1 and 10 in every 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 every 1,000 users)

• reduced heart function, cardiac arrest
• stomach swelling
• thirst
• a condition in which there is too much acid in the body
• low blood albumin levels
• difficulty breathing
• hallucinations
• medicine not effective enough

Frequency not known (cannot be estimated from available data)

• urinating frequently

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse 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 stated on the label and container after EXP.

This medicine does not require any special storage temperature. Keep the ampoules or vials in the outer packaging to protect from light.

6. Contents of the pack and other information

Composition of Dexdor

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The other components 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 final concentration of the solution after dilution must be 4 micrograms/ml or 8 micrograms/ml.

Appearance of the product and contents of the pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless solution.

Packaging

Glass ampoules of 2 ml

Glass vials of 2, 5 or 10 ml

Pack sizes

5 ampoules with 2 ml

25 ampoules with 2 ml

5 vials with 2 ml

4 vials with 4 ml

4 vials with 10 ml

Only certain 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

Further information on this medicinal product is available upon request from the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Dexdor 100 micrograms/ml concentrate for solution for infusion

Method of administration

Dexdor must be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anaesthesia in operating theatre patients. It must only be administered as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

Dexdor can be diluted with 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 prior to administration. The volumes required to prepare the infusion are shown in the table below.

If a concentration of 4 micrograms/ml is required:

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

The solution should be gently shaken to ensure thorough mixing.

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

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

Ringer's lactate, 5% glucose solution, sodium chloride 9 mg/mL (0.9%) injection solution, mannitol 200 mg/mL (20%), sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrronium bromide, 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 certain types of natural rubber. Although dexmedetomidine is dosed according to effect, it is recommended to use components with synthetic rubber or coated natural rubber stoppers.

Shelf life

Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C.

From a microbiological standpoint, 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 normally should not exceed 24 hours at 2–8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.