DEXMEDETOMIDINE BAXTER 100 micrograms/ml concentrate for infusion solution

Introduction

Package Leaflet: Information for the User

Dexmedetomidine Baxter 100 micrograms/ml Concentrate for Solution for Infusion EFG

Read all of this leaflet carefully before you start using 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 is Dexmedetomidine Baxter and what is it used for
2. What you need to know before you are given Dexmedetomidine Baxter
3. How to use Dexmedetomidine Baxter
4. Possible side effects
5. Storage of Dexmedetomidine Baxter
6. Contents of the pack and other information

1. What is Dexmedetomidine Baxter and what is it used for

This medicine 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 Dexmedetomidine Baxter

You should not be given Dexmedetomidine Baxter

• 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 cardiac 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 affecting blood supply to the brain.

Warnings and precautions

Before using this medicine, tell your doctor or nurse if you are in any of the following situations, as this medicine should be used with caution:

• if you have an abnormally slow heart rate (either due to a 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 low blood volume, for example after bleeding
• if you have certain heart diseases
• if you are an elderly person
• if you have a neurological disorder (e.g. head or spinal cord injury or stroke)
• if you have severe liver problems
• if you have ever developed a severe fever after using 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 aged 65 years or less when using this medicine, especially in patients admitted to the intensive care unit for reasons other than postoperative care, with more severe illness at admission to the intensive care unit and with 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 Dexmedetomidine Baxter

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 this medicine:

• 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 this medicine may increase this effect. This medicine should not be used with medicines that cause temporary paralysis.

Pregnancy and breastfeeding

This medicine should not be used during pregnancy or breastfeeding, unless clearly necessary.

Consult your doctor before using this medicine.

Driving and using machines

This medicine has an impact on your ability to drive and use machines. Once you have been given this medicine, you should not drive, operate machinery or work in hazardous situations until the effects have passed completely. Ask your doctor when you can resume these activities and return to this type of work.

This medicine contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; this is essentially "sodium-free".

3. How to use Dexmedetomidine Baxter

Intensive Care Hospitalization

This medicine will be administered by a doctor or nurse in the intensive care unit of a hospital.

Procedural Sedation/Conscious Sedation

This medicine will be administered by a doctor or nurse before and/or during diagnostic or surgical procedures that require sedation, for example, procedural sedation/conscious sedation.

Your doctor will decide the suitable dose for you. The amount of dexmedetomidine depends on your age, body weight, general state of health, the level of sedation required 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.

This medicine is diluted and administered as an infusion (drip) into your veins.

After Sedation/Waking Up

• Your doctor will keep you under 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 relieve severe pain may not be recommended for some time after treatment with this medicine. Consult your doctor about the use of these types of medicines and about alcohol consumption.

If you have been given too much Dexmedetomidine Baxter

If you have been given too much dexmedetomidine, your blood pressure may rise or fall, your heartbeats may slow down, you may breathe more slowly and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

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 in 10 and 1 in 100 users)

• 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 (affect between 1 in 100 and 1 in 1,000 users)

• decreased heart function, cardiac arrest
• stomach swelling
• thirst
• a condition where 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)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, 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) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine Baxter

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 label and carton after EXP.

This medicine does not require any special storage temperature.

After dilution

Chemical and physical stability has been demonstrated for 24 hours at 25°C.

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

Do not refrigerate.

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 Baxter

• The active substance is dexmedetomidine. Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine. Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).

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 of Dexmedetomidine Baxter and pack contents

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear and colorless solution.

Pack

2 ml glass vials

Pack size

5 vials of 2 ml

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Baxter Holding B.V.

Kobaltweg 49

3542 CE Utrecht

Netherlands

Manufacturer:

UAB Norameda

Meistru 8a, Vilnius

02189, Lithuania

or

Bieffe Medital S.P.A

Via Nuova Provinciale

23034-Grosotto (SO), Italy

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

Baxter, S.L.

Polígono Industrial Sector 14

C/Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Netherlands: Dexmedetomidine Baxter 100 microgram/ml concentraat voor oplossing voor infusie

Austria: Dexmedetomidin Baxter 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Belgium: Dexmedetomidine Baxter 100 microgrammes/ml solution à diluer pour perfusion

Denmark: Dexmedetomidine Baxter

Finland: Dexmedetomidine Baxter 100 mikrog/ml infuusiokonsentraatti, liuosta varten

Germany: Dexmedetomidin Baxter 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Greece: Dexmedetomidine/Baxter 100 μικρογραμμ?ρια/ml πυκν? δι?λυμα για

παρασκευ? διαλ?ματος προς ?γχυση

Ireland: Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Italy: Dexmedetomidina Baxter

Norway: Dexmedetomidine Baxter 100 mikrogram/ml konsentrat til infusjonsvæske,

oppløsning

Portugal: Dexmedetomidina Baxter

Spain: Dexmedetomidina Baxter 100 μg/ml concentrado para solución para perfusión EFG

Sweden: Dexmedetomidine Baxter

Cyprus: Dexmedetomidine/Baxter 100 μικρογραμμ?ρια/ml πυκν? δι?λυμα για

παρασκευ? διαλ?ματος προς ?γχυση

Luxembourg: Dexmedetomidine Baxter 100 microgrammes/ml, solution à diluer pour perfusion

United Kingdom: Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Date of last revision of this leaflet:June 2024

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 Baxter 100 micrograms/ml Concentrate for Solution for Infusion EFG

Route of administration

This medicine should be administered by healthcare professionals trained 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

This medicine can be diluted in glucose 50 mg/ml (5%), Ringer's Lactate solution, mannitol 200 mg/ml (20%) 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.

This medicine should be visually inspected for particles and coloration before administration.

This medicine has been shown to be compatible when administered with the following intravenous fluids and medicines:

Ringer's Lactate, glucose 5% solution, sodium chloride 9 mg/ml (0.9%) injectable solution, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate and a plasma substitute.

Compatibility studies have shown 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 or natural rubber seals.

Shelf life

Chemical and physical stability has been demonstrated for 24 hours at 25°C.

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

Do not refrigerate.