DEXMEDETOMIDINE EVER PHARMA 100 micrograms/ml concentrate for infusion solution

2. What you need to know before you are given Dexmedetomidine EVER Pharma

Dexmedetomidine EVER Pharma 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 (2nd or 3rd degree 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 medicine, tell your doctor or nurse if you are in any of the following situations, as Dexmedetomidine EVER Pharma should be used with caution:

• if you have an abnormally slow heart rate (either due to disease or due to high physical activity), 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 some 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 65 years or younger 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 EVER Pharma

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 Dexmedetomidine EVER Pharma:

• 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 EVER Pharma may increase this effect. Dexmedetomidine EVER Pharma should not be used with medicines that can cause temporary paralysis.

Pregnancy and breastfeeding

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

Consult your doctor before using this medicine.

Driving and using machines

Dexmedetomidine EVER Pharma has a major impact on your ability to drive and use machines. After you have been given Dexmedetomidine EVER Pharma, you should not drive, operate machinery or work in hazardous situations until the effects have passed completely. Consult your doctor when you can resume these activities and this type of work.

Dexmedetomidine EVER Pharma contains sodium

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

3. How Dexmedetomidine EVER Pharma is given

Intensive Care Hospitalization

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 that require sedation, i.e. for procedure sedation/conscious sedation.

Your doctor will decide the suitable dose for you. The amount of Dexmedetomidine EVER Pharma depends on your age, body mass, general state of health, the level of sedation needed 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.

Dexmedetomidine EVER Pharma 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 are intended to calm severe pain may not be recommended for use for a period of time after treatment with Dexmedetomidine EVER Pharma. Consult your doctor about the use of these types of medicines and about the use of alcohol.

If you have been given too much Dexmedetomidine EVER Pharma

If too much Dexmedetomidine EVER Pharma has been administered, your blood pressure may rise or fall, your heart beats 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 medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody 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 stop

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 where there is too much acid in the body
• low albumin level in the blood
• difficulty breathing
• hallucinations
• respiratory depression
• 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 or nurse, even if you think they might be unrelated to this medicine. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Dexmedetomidine EVER Pharma

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

Appearance of Dexmedetomidine EVER Pharma and pack contents

Concentrate for solution for infusion (sterile concentrate).

The concentrate is a clear 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 of 2 ml

25 ampoules of 2 ml

4 ampoules of 4 ml

5 ampoules of 4 ml

4 ampoules of 10 ml

5 ampoules of 10 ml

5 vials of 2 ml

4 vials of 4 ml

5 vials of 4 ml

4 vials of 10 ml

5 vials of 10 ml

Not all 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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder:

EVER Pharma Therapeutics Spain, S.L.

C/Toledo 170

28005 Madrid

Spain

Date of last revision of this leaflet: July 2023

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

This information is intended only for healthcare professionals:

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

Method of administration

Dexmedetomidine 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

Dexmedetomidine EVER Pharma can be diluted in glucose 50 mg/ml (5%), Ringer's solution, mannitol 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 below in table form 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.

Dexmedetomidine EVER Pharma should be visually inspected for particles and coloration before administration.

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

Ringer's solution, glucose 5% solution, sodium chloride 0.9% injectable solution, mannitol 20% 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 potential for absorption of dexmedetomidine by some types of natural rubber. Although dexmedetomidine is dosed to effect, it is recommended to use components with synthetic or coated natural rubber seals.

Shelf life

After dilution:

The physical-chemical stability of the diluted infusion (stability of the infusion solution) 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 before use are the responsibility of the user and should not normally exceed 24 hours at 2° to 8°C, unless the dilution has been made in controlled and validated aseptic conditions.