Dexmedetomidine Ever Pharma

Leaflet attached to the packaging: information for the user

Dexmedetomidine EVER Pharma

100 micrograms/ml, concentrate for solution for infusion

Dexmedetomidine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

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

Dexmedetomidine EVER Pharma contains the active substance dexmedetomidine, which belongs to a group of sedative medicines. The medicine is used to provide sedation (a state of calm, drowsiness or sleep) in adult patients in the intensive care unit in the hospital or during various diagnostic procedures and surgical procedures with maintained 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 (second or third degree heart block);
• if the patient has very low blood pressure that is resistant to treatment;
• if the patient has recently had a stroke or other severe illness affecting blood supply to the brain.

Warnings and precautions

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

• if the patient has an 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 a small blood volume, e.g. after 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 cord injury or stroke);
• if the patient has liver disease;
• if the patient has ever had a high fever after taking certain medicines, especially anesthetics.

This medicine may cause excessive urine production and increased thirst. If such symptoms occur, the doctor should be contacted. For further information, see section 4.
An increased risk of death has been observed in patients aged 65 and under who have been treated with this medicine, especially in patients admitted to the intensive care unit in a severe condition and for reasons other than post-surgical, as well as in younger patients. The doctor will decide whether this medicine is still suitable for the patient. The doctor will consider the benefits and risks associated with the use of this medicine compared to other sedative medicines.

Dexmedetomidine EVER Pharma and other medicines

The doctor or nurse should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.
The following medicines may enhance the effect of Dexmedetomidine EVER Pharma:

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

If the patient is taking medicines that lower blood pressure and slow heart rate, concurrent use of Dexmedetomidine EVER Pharma may enhance such effects. Dexmedetomidine EVER Pharma should not be used with medicines that cause periodic paralysis.

Pregnancy and breastfeeding

Dexmedetomidine EVER Pharma should not be used during pregnancy or breastfeeding unless absolutely necessary.
Before using this medicine, the doctor should be consulted.

Driving and using machines

Dexmedetomidine EVER Pharma has a major impact on the ability to drive and use machines.
After administration of Dexmedetomidine EVER Pharma, the patient should not drive, operate machinery, or work in hazardous conditions until the effect of the medicine has worn off completely. The patient should ask the doctor when they can resume these activities and return to work.

Dexmedetomidine EVER Pharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e. 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 the hospital's intensive care unit.
Procedural sedation/ sedation with maintained consciousness
Dexmedetomidine EVER Pharma is administered to the patient by a doctor or nurse before or during diagnostic procedures or surgical procedures requiring sedation, so-called procedural sedation/sedation with maintained consciousness.
The doctor will determine the dose suitable for the patient. The dose of Dexmedetomidine EVER Pharma depends on the patient's age, sex, overall health, and the required level of sedation, as well as the patient's response to the medicine. The doctor may change the dose of the medicine if necessary and will also monitor the patient's heart rate and blood pressure during treatment.
Dexmedetomidine EVER Pharma is diluted and administered to the patient intravenously in the form of an infusion (drip).

After sedation/awakening:

• The doctor will monitor the patient for several hours after sedation to ensure the patient feels well.
• The patient should not return home alone, they should be accompanied by a caregiver.
• For some time after administration of Dexmedetomidine EVER Pharma, the patient should not take medicines that facilitate sleep, cause sedation, or strong painkillers. The patient should discuss the use of these medicines and the use of alcohol with their doctor.

Use of a higher than recommended dose of Dexmedetomidine EVER Pharma

If the patient has received too high a dose of Dexmedetomidine EVER Pharma, they may experience increased or decreased blood pressure, slowed heart rate, slowed breathing, and a feeling of drowsiness. The doctor knows how to treat the patient according to their health condition.
If you have any further 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 or cessation of breathing

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
• anxiety
• high temperature
• withdrawal symptoms

Uncommon(may affect up to 1 in 100 people)

• heart rhythm disorders, cardiac arrest
• gastric swelling
• increased thirst
• acid-base imbalance in the body
• low albumin levels in the blood
• shortness of breath
• hallucinations
• shallow and reduced frequency of breathing
• lack of sufficient efficacy of the medicine

Unknown(frequency cannot be estimated from the available data)

• excessive urine production and increased thirst - these may be symptoms of a hormonal disorder called diabetes insipidus. If such symptoms occur, the doctor should be contacted.

Reporting of side effects
If side effects occur, including any side effects not listed in this leaflet, the doctor or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dexmedetomidine EVER Pharma

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Expiry Date (EXP)".
There are no special precautions for storage temperature. 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 of the medicine is dexmedetomidine.
• Each 1 ml of concentrate contains dexmedetomidine hydrochloride equivalent to 100 micrograms of dexmedetomidine.
• The other ingredients of the medicine 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, colorless solution.
Containers
Colorless glass ampoules of 2, 5 or 10 ml.
Colorless glass vials of 2, 5 or 10 ml
Pack size
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 authorization 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands
Dexmedetomidine EVER Pharma 100 micrograms/ml concentraat voor oplossing voor infusie
Germany
Dexmedetomidin EVER Valinject 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung
Norway
Dexmedetomidine EVER Pharma
Poland
Dexmedetomidine EVER Pharma
Portugal
Dexmedetomidina EVER Pharma 100 µg/ml Concentrado para solução para perfusão
Sweden
Dexmedetomidine EVER Pharma 100 mikrogram/ml koncentrat till infusionsvätska, lösning
Slovakia
Dexmedetomidine EVER Pharma 100 mikrogramov/ml infúzny koncentrát
Slovenia
Deksmedetomidin EVER Pharma 100 mikrogramov/ml koncentrat za raztopino za infundiranje
United Kingdom
Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion
Hungary
Dexmedetomidin EVER Pharma 100 mikrogramm/ml koncentrátum oldatos infúzióhoz
Italy
Dexmedetodimina EVER Pharma
Date of last revision of the leaflet: 12.07.2023
--------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:
(see also section 3)

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

Method of administration

Dexmedetomidine EVER Pharma may only be administered by medical personnel trained in the treatment of patients requiring intensive care or anesthesia care in the operating room. Dexmedetomidine EVER Pharma may only be administered as a diluted intravenous infusion using a controlled infusion set.

Preparation of the solution

To obtain the desired concentration of 4 micrograms/ml or 8 micrograms/ml before administration, Dexmedetomidine EVER Pharma can be diluted in 5% glucose solution 50 mg/ml, Ringer's solution, mannitol, or 0.9% sodium chloride solution 9 mg/ml for injection. The volumes required to prepare the infusion are shown in the following table.

In case of required concentration of 4 micrograms/ml:

In case of required concentration of 8 micrograms/ml:

The solution should be gently shaken to ensure thorough mixing.
Before administration, Dexmedetomidine EVER Pharma should be visually inspected for the presence of particulate matter and discoloration.
It has been shown that Dexmedetomidine EVER Pharma is compatible when administered with the following intravenous fluids and medicinal products:
Ringer's solution, 5% glucose solution, 0.9% sodium chloride solution 9 mg/ml for injection, 20% mannitol 200 mg/ml, thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate, phenylephrine hydrochloride, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, and plasma substitutes.
Compatibility studies have shown the possibility of adsorption of dexmedetomidine by certain types of natural rubber. Although dexmedetomidine is administered to achieve an effect, it is recommended to use plastic or rubber-coated stoppers.

Shelf life

After dilution:
The chemical and physical stability of the diluted infusion (stability of the infusion solution for 48 hours at 25 °C and during storage in the refrigerator (2°C -8°C)) has been demonstrated.
From a microbiological point of view, the product should be used immediately. If the medicine is not used immediately, the user is responsible for the further storage time and conditions of the medicine before use, which normally should not exceed 24 hours at 2-8°C, unless the dilution has been performed in controlled and validated aseptic conditions.