Dexmedetomidine B. Braun 8 micrograms/ml solution for infusion

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dexmedetomidine B. Braun 4 micrograms/ml solution for infusion

Dexmedetomidine B. Braun 8 micrograms/ml solution for infusion

Read this entire leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any side effects, consult your doctor, even if they are side effects 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 you are 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 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 you are given Dexmedetomidine B. Braun

Do not administer Dexmedetomidine B. Braun

• if you are allergic to dexmedetomidine or to any of the other ingredients of this medicine (listed in section 6);
• if you have certain heart rhythm disorders (second- or third-degree atrioventricular block);
• if you have very low blood pressure that does not respond to treatment;
• if you have recently had a stroke or other serious episodes 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 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 high 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 using this medicine, particularly in patients admitted to intensive care units for reasons other than postoperative care, those with more severe illness at admission, and younger patients. 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 with 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 increase 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 enhance this effect. Dexmedetomidine must not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidine 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 on the ability to drive and use machines 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 can resume these activities and return to such work.

Dexmedetomidine B. Braun contains sodium

This medicine contains 177.1 mg of sodium (main component of table/cooking salt) in each 50 ml vial. This corresponds to 8.8% of the maximum daily recommended sodium intake for an adult.

This medicine contains 354.2 mg of sodium (main component of table/cooking salt) in each 100 ml vial. This corresponds to 17.7% of the maximum daily recommended sodium intake for an adult.

3. How to use Dexmedetomidina B. Braun

This medicine will be administered to you by a doctor or nurse.

Your doctor will decide the appropriate dose for you. The amount of dexmedetomidine depends on your age, body weight, general health status, the required level of sedation, and your response to the medicine.

Your doctor may adjust your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidine is ready for use and is given as an intravenous infusion (drip) into your veins.

After sedation/recovery

• Your doctor will keep you under medical supervision for several hours after sedation to ensure you are well.
• You must not leave on your own; someone must accompany you home.
• Medicines that help you sleep, cause sedation, or those used to relieve severe pain may not be recommended for a period of time after receiving dexmedetomidine. Consult your doctor regarding the use of these medicines and alcohol consumption.

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

If you have been given too much dexmedetomidine, 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 medicine and the amount received.

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

4. Possible adverse effects

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

Very common (may affect more than 1 in 10 people)

• Slow heart rate.
• Low or high blood pressure.
• Changes in breathing pattern or breathing stoppage.

Common (may affect up to 1 in 10 people)

• Chest pain or heart attack.
• Fast heart rate.
• Low or high blood sugar levels.
• Nausea, vomiting, or dry mouth.
• Restlessness.
• High body temperature.
• Symptoms after stopping the medicine.

Uncommon (may affect up to 1 in 100 people)

• Reduced heart activity, cardiac arrest.
• Swelling of the abdomen.
• Thirst.
• A condition in which there is too much acid in the body.
• Low level of albumin in the blood.
• Difficulty breathing.
• Hallucinations.
• Medicine not effective enough.

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 adverse effects, consult your doctor, nurse, or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 label after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Use immediately after opening.

Do not use this medicine if you notice that 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. Pack contents and other information

Composition of Dexmedetomidine B. Braun

• The active substance is dexmedetomidine.

Dexmedetomidine B. Braun 4 micrograms/ml

Each ml of solution contains dexmedetomidine hydrochloride equivalent to 4 micrograms of dexmedetomidine.

Each 50 ml vial contains dexmedetomidine hydrochloride equivalent to 200 micrograms of dexmedetomidine.

Each 100 ml vial contains dexmedetomidine hydrochloride equivalent to 400 micrograms of dexmedetomidine.

Dexmedetomidine B. Braun 8 micrograms/ml

Each ml of solution contains dexmedetomidine hydrochloride equivalent to 8 micrograms of dexmedetomidine.

Each 50 ml vial contains dexmedetomidine hydrochloride equivalent to 400 micrograms of dexmedetomidine.

• The other components are sodium chloride and water for injections.

Appearance of the product and pack contents

Infusion solution.

Clear, colourless solution.

Packaging

Dexmedetomidine B. Braun 4 micrograms/ml

Polyethylene vials of 50 ml and 100 ml with a double-port stopper sealed with latex-free rubber.

Dexmedetomidine B. Braun 8 micrograms/ml

Polyethylene vials of 50 ml with a double-port stopper sealed with latex-free rubber.

Pack sizes

Dexmedetomidine B. Braun 4 micrograms/ml

10 vials of 50 ml

10 vials of 100 ml

Dexmedetomidine B. Braun 8 micrograms/ml

10 vials of 50 ml

Only some 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, SA

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

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

• Braun Medical, S.A.

Carretera de Terrassa 121,

08191 Rubí, Barcelona, Spain

Telephone: 93 586 62 00

This medicinal product is authorised in EEA Member States under the following names:

Date of the last review of this leaflet: April 2024.

Detailed information on this medicine 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 solution for infusion

Route of administration

Dexmedetomidine must be administered by healthcare professionals experienced in managing patients requiring intensive care or in managing anesthesia in operating room settings.

Dexmedetomidine must not be diluted prior to use: it is supplied ready for administration. It must not be mixed with other medicinal products.

Dexmedetomidine B. Braun must be administered exclusively as an intravenous infusion using a controlled infusion device.

Dexmedetomidine must not be administered as a bolus injection.

Compatibility studies have shown a potential for adsorption of dexmedetomidine to certain types of natural rubber. Although dosing of dexmedetomidine is based on effect, it is recommended to use components with synthetic rubber stoppers or coated natural rubber stoppers.