Dexmedetomidine ever pharma

Package leaflet: Information for the user

Dexmedetomidine EVER Pharma
100 micrograms/ml, concentrate for solution for infusion
Dexmedetomidinum
Please read all of this leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or nurse.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents

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

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

Dexmedetomidine EVER Pharma contains the active substance called dexmedetomidine, which
belongs to a group of medicines known as sedatives. The medicine is used to provide sedation (a state
of calm, drowsiness or sleep) in adult patients in an intensive care unit in hospital or during various diagnostic procedures and surgical interventions performed with preserved consciousness.

2. Important information before using Dexmedetomidine EVER Pharma

When not to use Dexmedetomidine EVER Pharma

• if the patient is allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6);
• if the patient has heart rhythm disorders (2nd or 3rd degree heart block);
• if the patient has very low blood pressure that is resistant to treatment;
• if the patient has recently suffered a stroke or another serious condition affecting blood supply to the brain.

Warnings and precautions
Before administering this medicine, inform the doctor or nurse if any of the following apply to the patient, as Dexmedetomidine EVER Pharma should be used with caution:

• if the patient has abnormally slow heart rate (due to illness or high physical fitness), as this may increase the risk of cardiac arrest;
• if the patient has low blood pressure;
• if the patient has low blood volume, e.g. following bleeding;
• if the patient has certain cardiac disorders;
• if the patient is elderly;
• if the patient has a neurological disorder (e.g. head or spinal injury, or stroke);
• if the patient has liver disease;
• if the patient has ever experienced high fever after taking certain medicines, particularly anaesthetics.

This medicine may cause excessive urination and increased thirst. If these symptoms occur, contact the doctor. For further information, see section 4.
An increased risk of death has been observed in patients aged 65 years and younger treated with this medicine, particularly in patients admitted to intensive care units who are in a more severe condition and for reasons other than post-surgical recovery, as well as in younger patients. The doctor will decide whether this medicine remains appropriate for the patient. The doctor will consider the benefits and risks associated with using this medicine compared to treatment with other sedative medicines.

Dexmedetomidine EVER Pharma and other medicines
Inform the doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take.
The following medicines may enhance the effects of Dexmedetomidine EVER Pharma:

• medicines that facilitate sleep or cause sedation (e.g. midazolam, propofol);
• strong pain-relieving medicines (e.g. opioids such as morphine, codeine);
• anaesthetics (e.g. sevoflurane, isoflurane).

If the patient is taking medicines that lower blood pressure and slow heart rate, concomitant use of Dexmedetomidine EVER Pharma may intensify these effects. Dexmedetomidine EVER Pharma must not be used together with medicines causing periodic paralysis.

Pregnancy and breastfeeding
Dexmedetomidine EVER Pharma must not be used during pregnancy or breastfeeding unless absolutely necessary.
Consult the doctor before using this medicine.

Driving and operating machinery
Dexmedetomidine EVER Pharma has a major influence on the ability to drive and operate machinery.
After receiving Dexmedetomidine EVER Pharma, the patient must not drive, operate machinery, or work in hazardous conditions until the effects of the medicine have completely worn off. Ask the doctor when it is safe to resume these activities and return to work.

Dexmedetomidine EVER Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, meaning the medicine is considered "sodium-free".

3. How to use Dexmedetomidine EVER Pharma

Intensive Care Unit
Dexmedetomidine EVER Pharma is administered to the patient by a doctor or nurse
in a hospital intensive care unit.
Procedural sedation / sedation with preserved consciousness
Dexmedetomidine EVER Pharma is administered to the patient by a doctor or nurse before
or during diagnostic procedures or surgical interventions requiring sedation, so-called
procedural sedation / sedation with preserved consciousness.
The doctor will determine the dose appropriate for the patient. The dose of Dexmedetomidine EVER Pharma depends on
the patient's age, sex, general health condition, required level of sedation, and the body's response to
the medication. The doctor may adjust the dose if necessary. The patient's heart function and blood pressure
will also be monitored during treatment.
Dexmedetomidine EVER Pharma is diluted and administered intravenously as an infusion
(IV drip).
After sedation / upon waking up:

• The doctor will supervise the patient for several hours after sedation to ensure the patient feels well.
• The patient should not return home alone; a caregiver should accompany them.
• For some time after receiving Dexmedetomidine EVER Pharma, the patient should not take medications that facilitate sleep, cause sedation, or strong painkillers. Discuss with the doctor the use of these medications and alcohol consumption.

Use of a higher than recommended dose of Dexmedetomidine EVER Pharma
If the patient has received too high a dose of Dexmedetomidine EVER Pharma,
blood pressure may increase or decrease, heart rate may slow down, breathing may become slower, and drowsiness may occur.
The doctor knows how to treat the patient appropriately according to their health condition.
If there are any further doubts regarding the use of this medicine, consult the doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very common (may occur in more than 1 in 10 people)

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

Common (may occur in 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
• withdrawal symptoms

Uncommon (may occur in up to 1 in 100 people)

• reduced heart function, cardiac arrest
• stomach swelling
• excessive thirst
• acid-base imbalance in the body
• low albumin levels in blood
• shortness of breath
• hallucinations
• shallow and reduced breathing rate
• lack of sufficient drug effectiveness

Frequency not known (frequency cannot be estimated from available data)

• passing large amounts of urine and excessive thirst – these may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if such symptoms occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables better assessment of medicine's safety profile and helps improve patient information.

5. How to store Dexmedetomidine EVER Pharma
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following "EXP".
No special temperature requirements for storage. Store ampoules or vials in the outer packaging to protect from light.

6. Contents of the pack and other information

What Dexmedetomidine EVER Pharma contains

• The active substance is dexmedetomidine.
• Each 1 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 ready-to-use solution after dilution should be either 4 micrograms/ml or 8 micrograms/ml.

What Dexmedetomidine EVER Pharma looks like and contents of the pack
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution.

Containers
Colourless glass ampoules with a capacity of 2, 5 or 10 ml.
Colourless glass vials with a capacity of 2, 5 or 10 ml.

Pack sizes
5 ampoules x 2 ml
25 ampoules x 2 ml
4 ampoules x 4 ml
5 ampoules x 4 ml
4 ampoules x 10 ml
5 ampoules x 10 ml
5 vials x 2 ml
4 vials x 4 ml
5 vials x 4 ml
4 vials x 10 ml
5 vials x 10 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Strasse 15
07745 Jena
Germany
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

For more detailed information on this medicine, please contact the local representative of the Marketing Authorisation Holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicinal product is authorised in the European Economic Area under the following names:

Information intended exclusively for medical professionals

Dexmedetomidine EVER Pharma, 100 micrograms/ml concentrate for solution for infusion
Administration method
Dexmedetomidine EVER Pharma must be administered only by medical personnel trained in the management of patients requiring intensive medical care or anesthesia care in an operating room. Dexmedetomidine EVER Pharma must be administered only as a diluted intravenous infusion using a controlled infusion delivery system.
Preparation of the solution
To achieve the desired concentration of 4 micrograms/ml or 8 micrograms/ml prior to administration, Dexmedetomidine EVER Pharma may be diluted with 5% glucose solution 50 mg/ml, Ringer's solution, mannitol, or 0.9% sodium chloride solution 9 mg/ml. The volumes required for the preparation of the infusion are given in the table below.
For the required concentration of 4 micrograms/ml:

In case of required concentration of 8 micrograms/ml:

Gently shake the solution to ensure thorough mixing.
Before administration, Dexmedetomidine EVER Pharma should be inspected visually for particulate matter and discoloration.
Dexmedetomidine EVER Pharma has been shown to be compatible when administered with the following intravenous fluids and medicinal products:
Ringer's lactate, 5% glucose solution, 0.9% sodium chloride solution 9 mg/ml for injection, 20% mannitol 200 mg/ml, sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrronium bromide, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and plasma substitutes.
Compatibility studies have shown that adsorption of dexmedetomidine may occur with certain types of natural rubber. Although dexmedetomidine is dosed to achieve effect, it is recommended to use plastic or natural rubber coated stoppers.
Shelf life
After dilution:
Chemical and physical stability of the diluted infusion has been demonstrated (solution for infusion remains stable for 48 hours at 25°C and during refrigerated storage (2°C - 8°C)).
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions prior to use, which generally should not exceed 24 hours at 2-8°C, unless dilution has been carried out under controlled and validated aseptic conditions.