Prospect: information for the user

Dexmedetomidine B.Braun 4micrograms/ml solution for infusion

Dexmedetomidine B.Braun 8micrograms/ml solution for infusion

Read this prospect carefully before this medication is administered to you, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section4.

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

2.What you need to know before Dexmedetomidine B.Braun is administered to you

3.How to use Dexmedetomidine B.Braun

4.Possible adverse effects

5.Storage of Dexmedetomidine B.Braun

6.Contents of the package and additional information

Dexmedetomidina B.Braun contains an active substance called dexmedetomidina, which belongs to a group of medicines called sedatives. It is used to provide sedation (a state of calmness, drowsiness, or sleep) in adult patients in intensive care units of hospitals or conscious sedation during various diagnostic or surgical procedures.

Do not administer Dexmedetomidina B.Braun

• if you are allergic to dexmedetomidina or any of the other components of this medication (listed in section6);
• if you have some heart rhythm disorders (grade2 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

Inform your doctor or nurse if you are in any of the following situations, as dexmedetomidina should be used with caution:

• if you have an abnormally slow heart rate (either due to illness or high physical exertion), as it may increase the risk of cardiac arrest.
• if you have low blood pressure.
• if you have low blood volume, for example after a hemorrhage.
• if you have certain heart diseases.
• if you are elderly.
• if you have a neurological disorder (for example, head or spinal cord injuries or stroke)
• if you have severe liver disease.
• if you have ever developed severe fever after receiving some medications, especially anesthetics.

This medication may cause a large amount of urine and excessive thirst, contact a doctor if these adverse effects occur. See section4 for more information.

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

Other medications and Dexmedetomidina B.Braun

Inform your doctor or nurse if you are using, have used recently, or may need to use any other medication.

The following medications may increase the effect of dexmedetomidina:

• sleeping medications or sedatives (e.g., midazolam, propofol),
• strong pain medications (e.g., opioids such as morphine, codeine),
• anesthetic medications (e.g., sevoflurane, isoflurane).

If you are using medications that lower your blood pressure and heart rate, the concurrent administration with dexmedetomidina may increase this effect. Dexmedetomidina should not be used with medications that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidina should not be administered during pregnancy or breastfeeding, unless clearly necessary.

Consult your doctor before receiving this medication.

Driving and operating machinery

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

Dexmedetomidina B.Braun contains sodium

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

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

This medication will be administered by a doctor or nurse.

Your doctor will decide on the appropriate dose for you. The amount of dexmedetomidina depends on your age, body weight, overall health, the level of sedation required, and how you respond to the medication.

Your doctor may adjust your dose as needed and will monitor your heart and blood pressure during treatment.

Dexmedetomidina is ready for use and is administered as an intravenous infusion.

After sedation/reanimation

• Your doctor will keep you under medical supervision for several hours after sedation to ensure you are doing well.
• You should not go home unless accompanied.
• Medications that help you sleep, cause sedation, or are intended to relieve intense pain may not be recommended for a period of time after receiving dexmedetomidina. Consult with your doctor about the use of these medications and alcohol consumption.

If you have been administered more Dexmedetomidina B.Braun than prescribed

If you have been given too much dexmedetomidina, your blood pressure may rise or fall, your heart rate 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 or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount received.

If you have any other questions about the use of this medication, consult with your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Slow heart rate.
• Low or high blood pressure.
• Change in breathing pattern or cessation of breathing.

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.
• Anxiety.
• High temperature.
• Withdrawal symptoms after stopping the medication.

Rare (may affect up to 1 in 100 people)

• Reduced heart activity, cardiac arrest.
• Abdominal swelling.
• Thirst.
• A condition in which there is too much acid in the body.
• Low albumin levels in the blood.
• Difficulty breathing.
• Hallucinations.
• The medication is not effective enough.

Unknown frequency (cannot be estimated from available data)

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

Reporting 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 prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Use immediately once opened.

Do not use this medication if you observe that the solution is not transparent, colorless, and free of particles.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Dexmedetomidine B.Braun

• The active ingredient is dexmedetomidine.

DexmedetomidineaB.Braun4micrograms/ml

Eachml of solution contains dexmedetomidine hydrochloride equivalent to 4micrograms of dexmedetomidine.

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

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

Dexmedetomidine B.Braun8micrograms/ml

Eachml of solution contains dexmedetomidine hydrochloride equivalent to 8micrograms of dexmedetomidine.

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

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

Appearance of the product and contents of the package

Infusion solution.

Transparent and colorless solution.

Containers

Dexmedetomidine B.Braun 4micrograms/ml

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

Dexmedetomidine B.Braun8micrograms/ml

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

Container sizes

Dexmedetomidine B.Braun4micrograms/ml

10vials of50ml

10vials of100ml

Dexmedetomidine B.Braun8micrograms/ml

10vials of50ml

Only some container sizes may be commercially available.

Marketing authorization holder and manufacturer responsible:

Marketing authorization holder

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Manufacturer responsible:

B. Braun Medical, SA

Carretera de Terrassa, 121

08191 – Rubí (Barcelona) – Spain

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

B. Braun Medical, S.A.

Carretera de Terrassa 121,

08191, Rubí, Barcelona, Spain

Phone: 93 586 62 00

This medicine is authorized in the EEA member states with the following names:

Last review date of this leaflet:April 2024.

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.

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This information is intended solely for healthcare professionals:

Dexmedetomidine B.Braun infusion solution

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 medications.

Dexmedetomidine 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 dexmedetomidine to be adsorbed to some types of natural rubber. Although dexmedetomidine is dosed based on effect, it is recommended to use components with synthetic rubber stoppers or natural rubber stoppers coated.