Dexmedetomidine Ever Pharma

Package leaflet: Information for the user

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

Dexmedetomidine
Please read this leaflet carefully before you are given 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. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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 will be administered to you
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 induce sedation (a state of calmness, drowsiness, or sleep) in adult patients admitted to hospital intensive care units or for conscious sedation during diagnostic or surgical procedures.

2. What you should know before being given Dexmedetomidina Ever Pharma

Do not be given 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 another serious condition involving reduced blood flow to the brain.

Warnings and precautions
Before you are given this medicine, inform your doctor or nurse if any of the following apply to you, as Dexmedetomidina Ever Pharma must be used with caution:

• if you have a slower than normal heart rate (due to illness or high levels of physical fitness)
• if you have low blood pressure
• if you have low blood volume, for example after bleeding
• if you suffer from heart disorders
• if you are elderly
• if you suffer from a neurological disorder (e.g. head injury, spinal cord injury, or stroke)
• if you suffer from severe liver problems
• if you have ever developed a high fever after taking certain medicines, particularly anaesthetics

Other medicines and Dexmedetomidina Ever Pharma
Inform your doctor or nurse if you are taking, have recently taken, or might take 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 pain-relieving medicines (e.g. opioids such as morphine, codeine)
• anaesthetic medicines (e.g. sevoflurane, isoflurane)

If you are taking medicines that lower blood pressure and heart rate, the concomitant administration of Dexmedetomidina Ever Pharma may enhance this effect.
Dexmedetomidina Ever Pharma must not be used with other medicines causing temporary paralysis.
Pregnancy and breastfeeding
Dexmedetomidina Ever Pharma must not be used during pregnancy or breastfeeding unless strictly necessary.
Ask your doctor for advice before using this medicine.
Driving and using machines
Dexmedetomidina Ever Pharma has a considerable effect on the ability to drive and use machines.
After receiving Dexmedetomidina Ever Pharma, you must not drive, operate machinery, or work in hazardous situations. Ask your doctor when you can resume these activities and return to such work.
Dexmedetomidina Ever Pharma contains sodium
Each ml of Dexmedetomidina Ever Pharma contains less than 1 mmol (approximately 3.5 mg) of sodium.

3. How Dexmedetomidina Ever Pharma will be administered to you

Hospital intensive care
Dexmedetomidina Ever Pharma will be administered to you by a doctor or nurse in a hospital intensive care unit.

Procedural sedation / conscious sedation
Dexmedetomidina Ever Pharma will be administered to you by a doctor or nurse before and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural sedation / conscious sedation.

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

Dexmedetomidina Ever Pharma is diluted and administered to you as an intravenous infusion (intravenous drip).

After sedation / waking up

• The doctor will monitor you for several hours after sedation to ensure you are well.
• You must not return home unaccompanied.
• For some time after administration of Dexmedetomidina Ever Pharma, sleeping medications causing sedation or strong painkillers may not be appropriate. Discuss with your doctor the use of these medicines and of alcoholic beverages.

If you are given more Dexmedetomidina Ever Pharma than you should have
If you are given too much Dexmedetomidina Ever Pharma, your blood pressure may decrease, your heart rate may slow down, and you may feel excessively sleepy. The doctor will know how to treat you based on your condition.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common ( affects more than 1 in 10 people )

• Slowing of the heartbeat
• Low or high blood pressure
• Changes in breathing pattern or respiratory arrest

Common ( affects between 1 and 10 in 100 people )

• Chest pain or heart attack
• Fast heartbeat
• Low or high blood sugar levels
• Nausea, vomiting or dry mouth
• Restlessness
• Symptoms due to stopping the medicine
• High temperature

Uncommon ( affects between 1 and 10 in 1,000 people )

• A condition where there is too much acid in the body
• Low level of albumin in the blood
• Hallucinations
• Reduced heart function
• Shortness of breath and temporary cessation of breathing
• Medicine not effective enough
• Stomach swelling
• Thirst

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexmedetomidine Ever Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after EXP.
This medicine does not require any special storage temperature. Keep the vials or bottles in the outer packaging to protect the medicine from light.

6. Package contents and other information

What Dexmedetomidine Ever Pharma contains

• 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 vial contains 200 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.

Description of the appearance of Dexmedetomidine Ever Pharma and package contents
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution.

Containers
Clear glass vials of 2 ml
Clear glass vials of 2, 5 or 10 ml

Packaging
5 x 2 ml vials
25 x 2 ml vials
5 x 2 ml vials
4 x 4 ml vials
5 x 4 ml vials
4 x 10 ml vials
5 x 10 ml vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach
Austria

Manufacturer
EVER Pharma Jena GmbH
Otto-Schott-Straße 15, 07745 Jena, Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria Dexmedetomidin EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung
Belgium Dexmedetomidine EVER Pharma 100 microgram/ml concentraat voor oplossing voor infusie
Dexmedetomidine EVER Pharma 100 microgrammes/ml solution à diluer pour perfusion
Dexmedetomidin EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung
Czech Republic Dexmedetomidine EVER Pharma
Germany Dexmedetomidin EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung
Denmark Dexmedetomidine EVER Pharma 100 mikrogram/ml koncentrat til infusionsvæske, opløsning
Spain Dexmedetomidina EVER Pharma 100 microgramos/ml concentrado para solución para perfusión
Finland Dexmedetomidine EVER Pharma 100 mikrog/ml infuusiokonsentraatti, liuosta varten
Italy Dexmedetodimina EVER Pharma
Ireland Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion
Netherlands Dexmedetomidine EVER Pharma 100 micrograms/ml concentraat voor oplossing voor infusie
Norway Dexmedetomidine EVER Pharma
Poland Dexmedetomidine EVER Pharma
Sweden Dexmedetomidine EVER Pharma 100 mikrogram/ml koncentrat till infusionsvätska, lösning
Slovakia Dexmedetomidine EVER Pharma 100 mikrogramov/ml infúzny koncentrát
United Kingdom Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion

The following information is intended for healthcare professionals only:
Dexmedetomidine Ever Pharma 100 micrograms/ml concentrate for solution for infusion

Route of administration
Dexmedetomidine Ever Pharma must be administered by healthcare professionals experienced in the management of patients requiring intensive care or in the management of anaesthesia in the operating theatre.
It must only be given as a diluted intravenous infusion using a controlled infusion device.

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

If the required concentration is 4 micrograms/ml
| Volume of Dexmedetomidine Ever Pharma 100 micrograms/ml concentrate for solution for infusion | Volume of diluent | Total infusion volume | |--- | --- | ---| | 2 ml | 48 ml | 50 ml | | 4 ml | 96 ml | 100 ml | | 10 ml | 240 ml | 250 ml | | 20 ml | 480 ml | 500 ml |

If the required concentration is 8 micrograms/ml
| Volume of Dexmedetomidine Ever Pharma 100 micrograms/ml concentrate for solution for infusion | Volume of diluent | Total infusion volume | |--- | --- | ---| | 4 ml | 46 ml | 50 ml | | 8 ml | 92 ml | 100 ml | | 20 ml | 230 ml | 250 ml | | 40 ml | 460 ml | 500 ml |

The solution should be gently agitated to ensure thorough mixing.
Dexmedetomidine Ever Pharma should be inspected visually for particulate matter and discoloration prior to administration.

Dexmedetomidine Ever Pharma is compatible when administered with the following intravenous fluids and medicinal products:
Ringer's lactate, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) injection solution, mannitol 200 mg/ml (20%), thiopentone sodium, 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 potential adsorption of dexmedetomidine by certain types of natural rubber. Although dosing of dexmedetomidine should be adjusted to achieve the desired effect, it is recommended to use synthetic components or lined natural rubber closures.

Shelf life
After dilution
Chemical and physical in-use stability has been demonstrated 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 storage time and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless dilution has been carried out under aseptic, controlled, and validated conditions.