Leaflet: information for the user

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

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

5.Storage of Dexmedetomidina EVER Pharma

6. Contents of the container and additional information

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

Do not administer Dexmedetomidina EVER Pharma:

• if you are allergic to dexmedetomidina or any of the other components of this medication (listed in section 6).
• if you have some 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 episodes that affect blood supply to the brain.

Warnings and precautions

Before using this medication, 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 an abnormally slow heart rate (either due to illness or due to high physical activity) 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 a severe fever after 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 section 4 for more information.

A higher risk of mortality has been observed in patients 65 years or older 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 EVER Pharma

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 EVER Pharma:

• medications that help you sleep or cause sedation (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 EVER Pharma may increase this effect. Dexmedetomidina EVER Pharma should not be used with medications that can cause temporary paralysis.

Pregnancy and breastfeeding

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

Consult your doctor before using this medication.

Driving and operating machinery

Dexmedetomidina EVER Pharma has a significant impact on your ability to drive and operate machinery. Once you have been administered Dexmedetomidina EVER Pharma, you should not drive, operate machinery, or work in hazardous situations until the effects have completely passed. Consult with your doctor when you can resume these activities and this type of work.

Dexmedetomidina EVER Pharma contains sodium

This medication contains less than 1 mmol of sodium (23mg) per ml, so it is considered “sodium-free”.

Intensive Hospital Care

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

Sedation for procedures/conscious sedation

A doctor or nurse will administer Dexmedetomidina EVER Pharma before and/or during diagnostic or surgical procedures that require sedation, that is, for sedation for procedures/conscious sedation.

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

After sedation/waking up

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

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

If too much Dexmedetomidina EVER Pharma has been administered, 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.

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 may experience them.

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

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

Frequent(may affect up to 1 in 10 people)

• chest pain or heart attack
• rapid heart rate
• low or high blood sugar levels
• nausea, vomiting, or dry mouth
• anxiety
• high temperature
• symptoms after stopping the medication

Rare(may affect up to 1 in 100 people))

• decreased heart function, cardiac arrest
• abdominal distension
• thirst
• a condition in which there is too much acid in the body
• low albumin levels in the blood
• difficulty breathing
• hallucinations
• depressed respiration
• the medication is not effective enough.

Unknown Frequency(cannot be estimated from available data)

• excessive urination 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 adverse effects, consult your doctor or nurse, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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 label and the packaging after CAD.

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

Dexmedetomidine EVER Pharma Composition

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

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

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

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

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

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

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

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

Appearance of Dexmedetomidine EVER Pharma and packaging contents

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a transparent and colorless solution.

Packaging

Colorless glass ampoules of 2, 5 or 10 ml.

Colorless glass vials of 2, 5 or 10 ml.

Package 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.

Some package sizes may only be marketed.

Marketing Authorization 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 about this medicinal product, please contact the local representative of the marketing authorization holder:

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

Last review date of this leaflet: July 2023

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

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

This information is intended solely for healthcare professionals :

Dexmedetomidina EVER Pharma 100 microgramos/ml concentrado para solución para perfusión

Administration

Dexmedetomidina EVER Pharma 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

Dexmedetomidina EVER Pharma can be diluted in 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 before administration. See below in the form of a table the volumes required 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 agitated to mix well.

Dexmedetomidina EVER Pharma should be visually inspected to detect particles and color before administration.

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

Ringer's lactate, glucose solution 5%, sodium chloride 9 mg/ml (0.9%) injection solution, mannitol 200 mg/ml (20%), 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 potential for dexmedetomidine absorption by some types of natural rubber. Although dexmedetomidine is dosed based on effect, it is recommended to use components with synthetic or natural rubber-coated joints.

Expiration date

After dilution:

The physical-chemical stability of the diluted infusion (infusion solution stability) has been demonstrated for 48 hours at 25°C and under refrigerated conditions (2°C-8°C).

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours between 2° and 8°C, unless the dilution has been performed in controlled and validated aseptic conditions.