DEXMEDETOMIDINE B. BRAUN 8 micrograms/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Dexmedetomidina B.Braun 4micrograms/ml solution for infusion

Dexmedetomidina B.Braun 8micrograms/ml solution for infusion

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 experience any side effects, talk to your doctor, even if you think they are not serious. See section 4.

Contents of the pack:

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

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

Dexmedetomidina B. Braun 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 Dexmedetomidina B. Braun

You should not be given Dexmedetomidina B.Braun

• 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 (heart block grade 2 or 3);
• 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 receiving this medicine, tell your doctor or nurse if you are in any of the following situations, as dexmedetomidine 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 a 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 receiving certain medicines, especially anesthetics.

This medicine may cause a large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.

A higher risk of mortality has been observed in patients 65 years or younger when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe disease at admission to the intensive care unit and with a younger age. Your doctor will decide if this medicine is still suitable for you. Your doctor will consider the benefits and risks of this medicine for you, compared to treatment with other sedatives.

Other medicines and Dexmedetomidina B.Braun

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 dexmedetomidine:

• 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 dexmedetomidine may increase this effect. Dexmedetomidine should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidine should not be given during pregnancy or breastfeeding, unless clearly necessary.

Consult your doctor before receiving this medicine.

Driving and using machines

The influence of dexmedetomidine on the ability to drive and use machines is important. Once you have been given dexmedetomidine, you should not drive, operate machinery or work in hazardous situations until the effects have completely disappeared. Consult your doctor when you can resume these activities and return to this type of work.

Dexmedetomidina B.Braun contains sodium

This medicine contains 177.1 mg of sodium (main component of table/cooking salt) in each 50 ml vial. This is equivalent to 8.8% of the maximum recommended daily 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 is equivalent to 17.7% of the maximum recommended daily sodium intake for an adult.

3. How to use Dexmedetomidina B. Braun

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

Your doctor will decide the right dose for you. The amount of dexmedetomidine depends on your age, body weight, general state of 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.

Dexmedetomidine is ready to use and will be given to you as an infusion (drip) into your veins.

After sedation/recovery

• Your doctor will keep you under medical supervision for a few hours after sedation to make sure you are well.
• You should not go home unless accompanied.
• Medicines that help you sleep, cause sedation or are intended to relieve severe pain may not be recommended for a period of time after receiving dexmedetomidine. Consult your doctor about the use of these medicines and about alcohol consumption.

If you have been given too much Dexmedetomidina B.Braun

If you have been given too much dexmedetomidine, 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.

In case of overdose, consult your doctor, pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount received.

If you have any other questions about the use of this medicine, consult 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 breathing stop.

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 temperature.
• Symptoms after stopping the medicine.

Uncommon (may affect up to 1 in 100 people)

• Decreased heart activity, cardiac arrest.
• Abdominal swelling.
• Thirst.
• A condition in which there is too much acid in the body.
• Low albumin level in the blood.
• Breathing difficulties.
• Hallucinations.
• The medicine is not effective enough.

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor, nurse or pharmacist, even if you think they are not serious. See section 4.

You can also report side effects directly to the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidina B. Braun

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 carton and on the label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Use immediately once opened.

Do not use this medicine if you notice that the solution is not clear, colorless and free of particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dexmedetomidina B.Braun

• The active substance is dexmedetomidine.

Dexmedetomidina 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.

Dexmedetomidina 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 ingredients are sodium chloride and water for injections.

Appearance and packaging

Solution for infusion.

Clear and colorless solution.

Packaging

Dexmedetomidina B. Braun 4 micrograms/ml

50 ml and 100 ml polyethylene vials with a double-sealed rubber stopper without latex.

Dexmedetomidina B. Braun 8 micrograms/ml

50 ml polyethylene vials with a double-sealed rubber stopper without latex.

Pack sizes

Dexmedetomidina B. Braun 4 micrograms/ml

10 vials of 50 ml

10 vials of 100 ml

Dexmedetomidina B. Braun 8 micrograms/ml

10 vials of 50 ml

Not all 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

You can request more information about this medicine from the local representative of the marketing authorisation holder:

• Braun Medical, S.A.

Carretera de Terrassa 121,

08191 Rubí, Barcelona, Spain

Phone: 93 586 62 00

This medicine is authorised in the Member States of the EEA under the following names:

Date of last revision of this leaflet:April 2024.

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

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This information is intended only for healthcare professionals:

Dexmedetomidine solution for infusion

Method of administration

Dexmedetomidine should be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anesthesia in patients in the operating room.

Dexmedetomidine should not be diluted before use: it is supplied ready for use. It should not be mixed with other medicines.

Dexmedetomidina B. Braun should be administered only as an intravenous infusion using a controlled infusion device.

Dexmedetomidine should not be administered as a bolus.

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