Dexmedetomidine B. Braun 100 micrograms/ml concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexmedetomidine B. Braun 100 micrograms/ml concentrate for solution for infusion EFG

Read the entire leaflet carefully before you are given 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 side effects, talk to your doctor, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Dexmedetomidine B. Braun is and what it is used for

Dexmedetomidine B. Braun contains an active substance called dexmedetomidine, which belongs to a group of medicines known as sedatives. It is used to provide sedation (a state of calmness, 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 being administered Dexmedetomidine B. Braun

Do not administer Dexmedetomidine B. Braun

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

Warnings and precautions

Before receiving this medicine, inform your doctor or nurse if you are in any of the following situations, as Dexmedetomidine B. Braun should be used with caution:

• If you have abnormally slow heart rate (either due to illness or 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 severe fever after taking certain medicines, especially anesthetics.

This medicine may cause excessive urination and excessive thirst; contact a doctor if these adverse effects occur. See section 4 for more information.

An increased risk of mortality has been observed in patients aged 65 years or younger when this medicine is used, particularly in patients admitted to intensive care units for reasons other than postoperative care, who had more severe illness upon admission and were younger. Your doctor will decide whether this medicine remains appropriate for you. Your doctor will consider the benefits and risks of this medicine for you compared to treatment with other sedatives.

Other medicines and Dexmedetomidine B. Braun

Inform your doctor or nurse if you are taking, have recently taken, or might need to 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 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, concomitant administration with Dexmedetomidine may increase this effect. Dexmedetomidine must not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidine B. Braun must not be administered during pregnancy or breastfeeding unless clearly necessary.

Consult your doctor before receiving this medicine.

Driving and using machines

The effect of Dexmedetomidine B. Braun on the ability to drive and operate machinery is significant. After receiving Dexmedetomidine, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Consult your doctor about when you may resume these activities and return to such work.

Dexmedetomidine B. Braun contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 2 ml and 4 ml vial; therefore, it is essentially "sodium-free".

This medicine contains 35.4 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This corresponds to 1.8% of the maximum daily sodium intake recommended for an adult.

3. How to use Dexmedetomidine B. Braun

Hospital intensive care

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

Sedation for procedures / procedural sedation (conscious sedation)

Dexmedetomidine will be administered to you 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 Dexmedetomidine depends on your age, body weight, general health, the required level of sedation, and your response to the medication. Your doctor may adjust your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidine B. Braun is diluted and administered as an intravenous infusion (intravenous drip).

After sedation / recovery

• Your doctor will keep you under medical supervision for several hours after sedation to ensure you are doing well.
• You should not go home alone.
• Medicines that help you sleep, cause sedation, or those intended to relieve severe pain may not be advisable for a period of time after receiving Dexmedetomidine B. Braun. Consult your doctor regarding the use of these medicines and alcohol consumption.

If you have been given more Dexmedetomidine B. Braun than you should have

If you have been given too much Dexmedetomidine B. Braun, your blood pressure may rise or fall, 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.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medication and the amount received.

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 will experience them.

Very common (affect more than 1 in every 10 users)

• Slow heart rate.
• Low or high blood pressure.
• Changes 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 activity, cardiac arrest.
• Swelling of the abdomen.
• Thirst.
• A condition in which there is too much acid in the body.
• Low blood albumin levels.
• Difficulty breathing.
• Hallucinations.
• The medicine is not sufficiently effective.

Frequency not known (cannot be estimated from available data)

• Large volume of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if this occurs.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine B. Braun

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the label of the ampoule after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After dilution

Do not refrigerate.

Chemical and physical in-use stability has been demonstrated for up to 48 hours at 25 °C.

From a microbiological standpoint, the product should be used immediately, unless the method of opening excludes the risk of microbial contamination. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.

Do not use this medicine if the solution is not clear, colourless and free from particles.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexmedetomidine B.Braun

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.

Each 2 ml ampoule contains dexmedetomidine hydrochloride equivalent to 200 micrograms of dexmedetomidine.

Each 4 ml ampoule contains dexmedetomidine hydrochloride equivalent to 400 micrograms of dexmedetomidine.

Each 10 ml ampoule contains dexmedetomidine hydrochloride equivalent to 1,000 micrograms of dexmedetomidine.

• The concentration of the final solution after dilution must be 4 micrograms/ml or 8 micrograms/ml.
• The other components are sodium chloride and water for injections.

Nature of the product and contents of the container

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless solution.

Containers

Colourless glass ampoules of 2, 4 or 10 ml.

Pack sizes

5 ampoules of 2 ml, 10 ampoules of 2 ml, 25 ampoules of 2 ml.

4 ampoules of 4 ml, 10 ampoules of 4 ml.

4 ampoules of 10 ml, 10 ampoules of 10 ml.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Manufacturer

• Braun Medical, S.A.

Ronda de los Olivares, Parcela 11,

Polígono Industrial Los Olivares

23009 Jaén (Jaén), Spain

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

• Braun Medical, S.A.

Ctra. Terrasa, 121

08191 Rubí (Barcelona), Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary: March 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es

This information is intended for healthcare professionals only:

Dexmedetomidine B. Braun 100 micrograms/ml concentrate for solution for infusion EFG

Route of administration

Dexmedetomidine B. Braun must be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anesthesia in operating room settings. It must be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

Dexmedetomidine B. Braun can be diluted with glucose 50 mg/mL (5%), Ringer's solution, or sodium chloride 9 mg/mL (0.9%) solution for injection to achieve the required concentration of 4 micrograms/mL or 8 micrograms/mL prior to administration. See the table below for the volumes required to prepare the infusion.

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.

Before administration, the solution should be inspected visually to ensure it is clear and colourless. It should not be used if any particulate matter is observed.

Dexmedetomidine B. Braun has been shown to be compatible when administered with the following intravenous fluids and medications:

Lactated Ringer's solution, 5% glucose solution, 9 mg/mL (0.9%) sodium chloride injectable solution, sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besilate, 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 dosing is based on effect, it is recommended to use components with synthetic rubber or coated natural rubber stoppers.

Shelf life after dilution

Do not refrigerate.

Chemical and physical stability in use has been demonstrated for up to 48 hours at 25 °C.

From a microbiological standpoint, the product should be used immediately, unless the method of opening excludes the risk of microbial contamination. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.