DEXMEDETOMIDINE B. BRAUN 100 micrograms/ml concentrate for infusion solution

Introduction

Package Leaflet: Information for the User

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

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 get any side effects, talk to your doctor, even if you think they might be unrelated to the medicine. See section 4.

Contents of the pack:

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 Dexmedetomidine B. Braun is used
4. Possible side effects
5. Storage of 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 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 of hospitals or conscious sedation during various diagnostic or surgical procedures.

2. What you need to know before you are given Dexmedetomidine B. Braun

Dexmedetomidine B. Braun must not be given to you:

• 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 (grade 2 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 conditions 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 B. Braun 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.

Other medicines and Dexmedetomidine B. Braun

Tell your doctor or nurse if you are using, have recently used or might use any other medicines.

The following medicines may enhance 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 together with Dexmedetomidine may increase this effect. Dexmedetomidine should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidine B. Braun 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 B. Braun on the ability to drive and use machines is important. Once you have been given Dexmedetomidine, you should not drive, operate machines 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.

Dexmedetomidine B. Braun contains sodium

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

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

3. How Dexmedetomidine B. Braun is used

Hospital intensive care

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

Sedation for procedures/conscious sedation

Dexmedetomidine 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 the suitable dose for you. The amount of Dexmedetomidine depends on your age, body weight, general health, the level of sedation needed and how you respond to the medicine. 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 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 unaccompanied.
• 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 B. Braun. Consult your doctor about the use of these medicines and about alcohol consumption.

If you have been given too much Dexmedetomidine B. Braun

If you have been given too much Dexmedetomidine 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 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, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (affect more than 1 in 10 users)

• slow heart rate
• low or high blood pressure
• change in breathing pattern or breathing stop

Common (affect between 1 and 10 in 100 users)

• chest pain or heart attack
• fast heart rate
• low or high sugar levels
• nausea, vomiting or dry mouth
• restlessness
• high temperature
• symptoms after stopping the medicine

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

• reduced 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
• difficulty breathing
• hallucinations
• the medicine is not effective enough.

Frequency not known (cannot be estimated from the 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 of side effects

If you experience any side effects, talk to your doctor, nurse or pharmacist, even if you think they might be unrelated to the medicine.

You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website www.notificaRAM.es. By reporting side 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 which is stated on the carton and on the ampoule label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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, the storage times and conditions during use are the responsibility of the user.

Do not use this medicine if you notice that the solution is not transparent, 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 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 should be 4 micrograms/ml or 8 micrograms/ml.
• The other ingredients are sodium chloride and water for injections.

Appearance and pack contents

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution.

Packs

Colorless 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

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

B.Braun Medical, S.A.

Ronda de los Olivares, parcela 11

Polígono Industrial Los Olivares

23009 Jaén – Spain

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

Date of last revision of this leaflet: January 2022

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

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This information is intended only for healthcare professionals:

Dexmedetomidine B. Braun concentrate for solution for infusion

Method of administration

Dexmedetomidine B. Braun should be administered by healthcare professionals experienced in the management of patients who require 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 glucose 50 mg/mL (5%), Ringer's solution or sodium chloride 9 mg/mL (0.9%) injectable solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml before administration. See the table below for the volumes needed to prepare the infusion.

In case 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 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 medicines:

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

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

Expiry date 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, the storage times and conditions during use are the responsibility of the user.