DEXMEDETOMIDINA 100 MICROGRAMMI/ML Concentrate for infusion solution

Зміст інструкції

1. Dexmedetomidina Ever Pharma 100 micrograms/ml concentrate for solution for infusion
   1. What Dexmedetomidine Ever Pharma is and what it is used for
   2. What you need to know before you are given Dexmedetomidine Ever Pharma
   3. How Dexmedetomidina Ever Pharma will be administered to you
   4. Possible side effects
   5. How to store Dexmedetomidina Ever Pharma
   6. Contents of the pack and other information
2. Dexmedetomidina Ever Pharma 100 micrograms/ml concentrate for solution for infusion

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

Dexmedetomidina

Read this leaflet carefully before you are given this medicine as 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 any side effects occur, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Dexmedetomidina Ever Pharma is and what it is used for
• 2. What you need to know before you are given Dexmedetomidina Ever Pharma
• 3. How you will be given Dexmedetomidina Ever Pharma
• 4. Possible side effects
• 5. How to store Dexmedetomidina 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 an active ingredient called dexmedetomidine which belongs to a
group of medicines called sedatives. It is used to induce sedation (a state of calm, drowsiness or
sleep) for adult patients admitted to hospital intensive care units or for conscious sedation during
diagnostic or surgical procedures.

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

Do not be given Dexmedetomidine 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 heart 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 blood flow to the brain.

Warnings and precautions
Before you are given this medicine, tell your doctor or nurse if you have any of the following
conditions, as Dexmedetomidine Ever Pharma must be used with caution:

• if you have a slower than normal heartbeat (due to an illness or high levels of physical activity)
• if you have low blood pressure
• if you have a low blood volume, for example after bleeding
• if you suffer from heart disorders
• if you are elderly
• if you suffer from a neurological disorder (for example injuries to the head, spinal cord, or stroke)
• if you suffer from severe liver problems
• if you have ever developed a high fever after taking certain medicines, in particular anesthetics

Other medicines and Dexmedetomidine Ever Pharma
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines.
The following medicines can increase the effect of Dexmedetomidine Ever Pharma:

• medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
• powerful pain 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
concurrent administration of Dexmedetomidine Ever Pharma may increase this effect.
Dexmedetomidine Ever Pharma should not be used with other medicines that cause temporary paralysis.

Pregnancy and breastfeeding
Dexmedetomidine Ever Pharma should not be used during pregnancy or breastfeeding unless
strictly necessary.
Ask your doctor for advice before using this medicine.

Driving and using machines
Dexmedetomidine Ever Pharma has a significant effect on the ability to drive and use
machines.
After the administration of Dexmedetomidine Ever Pharma do not drive, use machines or work
in dangerous situations. Ask your doctor when you can resume these activities and when you can return to
this type of work.

Dexmedetomidine Ever Pharma contains sodium
Each ml of Dexmedetomidine 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 hospital intensive care units.

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 that require sedation, i.e. procedural sedation/conscious sedation.
The doctor will decide the appropriate dose for you. The amount of Dexmedetomidina Ever Pharma depends on age, weight, general health status, the level of sedation required and how you respond to the medicine. The doctor may
adjust the dose if necessary, and will monitor your heart rate and blood pressure during treatment.
Dexmedetomidina Ever Pharma is diluted and administered to you as an infusion (drip) into a vein.

After sedation/awakening

• The doctor will keep you under observation for a few hours after sedation to make sure you are well.
• You must not return home without being accompanied.
• For some time, following the administration of Dexmedetomidina Ever Pharma, sleeping medications, those that cause sedation or strong painkillers may not be appropriate. Discuss the use of these medications and alcoholic beverages with your doctor.

If you are given more Dexmedetomidina Ever Pharma than you should
If you are given too much Dexmedetomidina Ever Pharma, your blood pressure may decrease, your
heartbeat may slow down and you may feel more 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, ask 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)

• Slowed heartbeat
• Low or high blood pressure
• Changes in breathing pattern or respiratory arrest

Common( affects 1 to 10 in 100 people)

• Chest pain or heart attack
• Fast heart rate
• Low or high blood sugar levels
• Nausea, vomiting or dry mouth
• Restlessness
• Withdrawal symptoms
• High temperature

Uncommon( affects 1 to 10 in 1,000 people)

• A condition in which 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
• The medicine is not effective enough
• Stomach swelling
• Thirst

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through 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 Dexmedetomidina Ever Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the label and on the package after SCAD.
This medicine does not require any particular storage temperature. Keep the vials or
ampoules in the outer packaging to protect the medicine from light.

6. Contents of the pack and other information

What contains Dexmedetomidina Ever Pharma

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

Each 2 ml vial contains 200 micrograms of dexmedetomidine (as hydrochloride).
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).
The concentration of the final solution after dilution must be 4 micrograms/ml or 8
micrograms/ml.

Description of the appearance of Dexmedetomidina Ever Pharma and contents of the pack
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colorless solution.
Containers
Glass vials of 2 ml
Glass ampoules of 2, 5 or 10 ml
Packs
5 x 2 ml vials
25 x 2 ml vials
5 x 2 ml ampoules
4 x 4 ml ampoules
5 x 4 ml ampoules
4 x 10 ml ampoules
5 x 10 ml ampoules
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
denominations:
Austria Dexmedetomidin EVER Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer
Infusionslösung
Belgium Dexmedetomidine EVER Pharma 100 microgram/ml concentrate for solution for infusion
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 concentrate for infusion solution
Spain Dexmedetomidina EVER Pharma 100 microgramos/ml concentrated for solution for
infusion
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 concentrate for solution for infusion
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/mlconcentrate for solution for infusion
The following information is only intended for healthcare professionals:

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

Method of administration
Dexmedetomidina Ever Pharma must be administered by healthcare professionals specialized in the management
of patients requiring intensive care or in the management of anesthesia for patients in the operating room.
It must be administered only by 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%) injectable solutions to obtain the required concentration of 4
micrograms/ml or 8 micrograms/ml before administration. See the table below for the
volumes needed to prepare the infusion.

In the case where the required concentration is 4 micrograms/ml
Volume of Dexmedetomidina Ever Pharma100
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

In the case where the required concentration is 8 micrograms/ml
Volume of Dexmedetomidina Ever Pharma100
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 shaken to mix it well.
Dexmedetomidina Ever Pharma must be visually inspected for particles and
color changes before administration.
Dexmedetomidina Ever Pharma is compatible when administered with the following intravenous fluids and the
following medications:
Ringer's lactate, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) injectable solution, mannitol
200 mg/ml (20%), sodium thiopental, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine,
atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine hydrochloride,
atropine sulfate, dopamine, norepinephrine, dobutamine, midazolam, morphine sulfate, fentanyl citrate and
plasma substitutes.
Compatibility studies have shown a potential adsorption of dexmedetomidine by some types
of natural rubber. Although dexmedetomidine is dosed until effect is achieved, it is recommended to
use synthetic components or natural rubber gaskets with a coating.

Period of validity

After dilution
Chemical and physical stability during use has been demonstrated for 48 hours at 25 °C under refrigerated conditions (2°C-
8°C)
From a microbiological point of view, the product must be used immediately.
If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 24 hours at 2-8°C, unless the
dilution has been carried out under controlled and validated aseptic conditions.