Dexmedetomidine Ever Pharma 100 micrograms/ml concentrate for infusion solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion

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 questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1. What Dexmedetomidine EVER Pharma is and what it is used for
2. What you need to know before Dexmedetomidine EVER Pharma is administered to you
3. How Dexmedetomidine EVER Pharma is administered
4. Possible side effects
5. How to store Dexmedetomidine EVER Pharma
6. Contents of the pack and other information

1. What Dexmedetomidina EVER Pharma is and what it is used for

Dexmedetomidina EVER Pharma contains an active substance called dexmedetomidine, which belongs to a group of medicines known as sedatives. It is used to provide conscious sedation (a state of calm, drowsiness, or sleep) in adult patients in hospital intensive care units or during various diagnostic or surgical procedures.

2. What you need to know before Dexmedetomidina EVER Pharma is administered to you

Do not use Dexmedetomidina EVER Pharma:

• if you are allergic to dexmedetomidine or to any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart rhythm disorders (second- or third-degree atrioventricular block).
• if you have very low blood pressure that does not respond to treatment.
• if you have recently had a stroke or other serious episodes affecting blood supply to the brain.

Warnings and precautions

Before this medicine is used, inform your doctor or nurse if you are in any of the following situations, as Dexmedetomidina EVER Pharma should be used with caution:

• if you have abnormally slow heart rate (either due to illness or due to high physical fitness), as this 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 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 a severe fever after taking certain medicines, especially anesthetics

This medicine may cause excessive urination and excessive thirst. Contact a doctor if these adverse effects occur. See section 4 for more information.

An increased risk of mortality has been observed in patients aged 65 years or younger when using this medicine, particularly in patients admitted to intensive care units for reasons other than postoperative care, those with more severe illness at admission, and those who are relatively younger. Your doctor will decide whether this medicine remains appropriate 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 EVER Pharma

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

The following medicines may increase the effect of Dexmedetomidina EVER Pharma:

• medicines that help you sleep or cause sedation (e.g., midazolam, propofol)
• strong painkillers (e.g., opioids such as morphine, codeine)
• anesthetic medicines (e.g., sevoflurane, isoflurane)

If you are taking medicines that lower your blood pressure and heart rate, concomitant administration with Dexmedetomidina EVER Pharma may enhance this effect. Dexmedetomidina EVER Pharma must not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

Dexmedetomidina EVER Pharma must not be used during pregnancy or breastfeeding unless clearly necessary.

Consult your doctor before using this medicine.

Driving and using machines

Dexmedetomidina EVER Pharma has a major impact on the ability to drive and use machines. After receiving Dexmedetomidina EVER Pharma, you must not drive, operate machinery, or work in hazardous situations until the effects have completely worn off. Consult your doctor to determine when you can resume these activities and types of work.

Dexmedetomidina EVER Pharma contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per ml and is therefore considered "sodium-free".

3. How Dexmedetomidine EVER Pharma is administered

Hospital intensive care

Dexmedetomidine EVER Pharma is administered by a doctor or nurse in the intensive care unit of a hospital.

Sedation for procedures/conscious sedation

Dexmedetomidine EVER Pharma is administered by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e., for procedural sedation/conscious sedation.

Your doctor will decide the appropriate dose for you. The amount of Dexmedetomidine EVER Pharma depends on your age, body weight, general health, the level of sedation required, and how you respond to the medication. Your doctor may adjust your dose if necessary and will monitor your heart and blood pressure during treatment.

Dexmedetomidine EVER Pharma is diluted and administered to you as an intravenous infusion (drip).

After sedation/waking up

• Your doctor will keep you under supervision for several hours after sedation to ensure you are doing well.
• You must not go home unless accompanied.
• Medicines that help you sleep, cause sedation, or those intended to relieve severe pain may not be recommended for use for a period of time after treatment with Dexmedetomidine EVER Pharma. Consult your doctor about using these types of medicines and about alcohol consumption.

If you have been given more Dexmedetomidine EVER Pharma than you should have

If too much Dexmedetomidine EVER Pharma has been administered, your blood pressure may rise or fall, your heart rate may become slower, your breathing may slow down, and you may feel more drowsy. Your doctor will know how to treat you based on your condition.

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

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

• slow heart rate
• low or high blood pressure
• changes in breathing pattern or breathing stoppage

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)

• reduced heart function, cardiac arrest
• abdominal distension
• thirst
• a condition in which there is too much acid in the body
• low level of albumin in the blood
• difficulty breathing
• hallucinations
• respiratory depression
• medicine not sufficiently effective

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine EVER Pharma

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label and packaging after EXP.

This medicine does not require special storage temperature conditions. Store the ampoules or vials in the outer packaging to protect from light.

6. Contents of the pack and other information

Composition of Dexmedetomidine EVER Pharma

• The active substance is dexmedetomidine.
• Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The other components are sodium chloride and water for injections.

Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).

Each 4 ml ampoule contains 400 micrograms of dexmedetomidine (as hydrochloride).

Each 10 ml ampoule contains 1000 micrograms of dexmedetomidine (as hydrochloride).

Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).

Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).

Each 10 ml vial contains 1000 micrograms of dexmedetomidine (as hydrochloride).

The final concentration of the solution after dilution must be 4 micrograms/ml or 8 micrograms/ml.

Appearance of Dexmedetomidine EVER Pharma and contents of the pack

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear, colourless solution.

Packaging

Colourless glass ampoules of 2, 5 or 10 ml

Colourless glass vials of 2, 5 or 10 ml

Pack sizes

5 ampoules with 2 ml

25 ampoules with 2 ml

4 ampoules with 4 ml

5 ampoules with 4 ml

4 ampoules with 10 ml

5 ampoules with 10 ml

5 vials with 2 ml

4 vials with 4 ml

5 vials with 4 ml

4 vials with 10 ml

5 vials with 10 ml

Only some pack sizes may be marketed.

Marketing Authorisation Holder

EVER Valinject GmbH.

Oberburgau 3

A-4866 Unterach

Austria

Manufacturer

Ever Pharma Jena GmbH

Otto Schott Strasse 15

07745 Jena

Germany

For further information regarding this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

Date of the most recent review of this leaflet: July 2023

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

This information is intended solely for healthcare professionals:

Dexmedetomidina EVER Pharma 100 micrograms/ml concentrate for solution for infusion

Route of administration

Dexmedetomidina EVER Pharma must be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anesthesia in operating room patients. It must be administered only as a diluted intravenous infusion using a controlled infusion device.

Preparation of the solution

Dexmedetomidina EVER Pharma may be diluted with glucose 50 mg/ml (5%), Ringer's solution, mannitol, or sodium chloride 9 mg/ml (0.9%) injection solution to achieve the required concentration of 4 micrograms/ml or 8 micrograms/ml prior to administration. See the table below for the volumes required to prepare the infusion.

If 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 ensure thorough mixing.

Dexmedetomidine EVER Pharma should be inspected visually for particulate matter and discoloration prior to administration.

Dexmedetomidine EVER Pharma has been shown to be compatible when administered with the following intravenous fluids and medications:

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

Compatibility studies have shown potential for absorption of dexmedetomidine by certain types of natural rubber. Although dexmedetomidine is dosed according to effect, it is recommended to use components with synthetic rubber or coated natural rubber closures.

Expiry

After dilution:

The diluted infusion has been shown to be physically and chemically stable (solution stability for infusion) for 48 hours at 25°C and under refrigerated conditions (2°C–8°C).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the times and conditions of storage prior to use are the responsibility of the user and normally should not exceed 24 hours between 2°C and 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.