Prospect: information for the user

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

Read this prospect thoroughly before this medication is administered to you, as 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 suffered a stroke or other serious conditions 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 B.Braun 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.

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 potentiate 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 B.Braun 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 B.Braun 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 your doctor when you can resume these activities and return to this type of work.

Dexmedetomidina B.Braun contains sodium

This medication contains less than 1mmol of sodium (23mg) per 2ml and 4ml ampoule; this is essentially “sodium-free”.

This medication contains 35.4mg of sodium (main component of table salt/for cooking) per 10ml ampoule. This is equivalent to 1.8% of the recommended maximum daily sodium intake for an adult.

Intensive Hospital Care

Dexmedetomidina B.Braun is administered by a doctor or nurse in the intensive care unit of a hospital.

Sedation for Procedures / Conscious Sedation

Dexmedetomidina is administered by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, e.g. sedation for procedures / conscious sedation.

Your doctor will decide on the appropriate dose for you. The amount of Dexmedetomidina depends on your age, body mass, general state of 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 B.Braun is diluted and administered as an infusion (drip) into your veins.

After Sedation / Resuscitation

• 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 B.Braun. Consult your doctor about the use of these medications and alcohol consumption.

If You Have Been Given Too Much Dexmedetomidina B.Braun

If you have been given too much Dexmedetomidina B.Braun, your blood pressure may rise or fall, your heartbeats 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, ask your doctor.

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

Very Frequent (affect more than 1 in 10 users)

• Slow heart rate
• Low or high blood pressure
• Change in breathing pattern or respiratory arrest

Frequent (affect between 1 and 10 in 100 users)

• 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 (affect between 1 and 10 in 1,000 users)

• Reduced heart activity, cardiac arrest
• Abdominal swelling
• Thirst
• A condition with 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 ampoule label after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

After dilution

Do not refrigerate.

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

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

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 principle is dexmedetomidine. Eachml of concentrate contains dexmedetomidine hydrochloride equivalent to 100micrograms of dexmedetomidine.

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

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

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

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

Appearance of the product and contents of the package

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a transparent and colorless solution.

Containers

Colorless glass ampoules of 2, 4 or 10ml

Container sizes

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

4ampoules of 4ml, 10ampoules of 4ml

4ampoules of 10ml, 10ampoules of 10ml

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

B. Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen

Germany

Responsible for manufacturing

B.Braun Medical, S.A.

Ronda de los Olivares, parcela 11

Polígono Industrial Los Olivares

23009 Jaén – Spain

This medicinal product is authorized in the Member States of the EEA with the following names:

Last review date of this leaflet: January 2022

Theinformation on this medicinal product 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 concentrate for solution for infusion

Administration

Dexmedetomidine B.Braun 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. It should be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

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

For a concentration of 4micrograms/ml:

For a concentration of 8micrograms/ml:

The solution should be gently agitated to mix well.

Before administration, the solution should be visually inspected to ensure it is transparent and colorless. 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:

Ringer lactate, 5% glucose solution, 0.9% sodium chloride solution, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besilate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, norepinephrine, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma substitute.

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.

Expiry date after dilution

Do not refrigerate.

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

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