Patient leaflet - Dexmedetomidine Ever Pharma 100 micrograms / ml concentrate for solution for infusion
1. What Dexmedetomidine EVER Pharma is and what it is used for
Dexmedetomidine EVER Pharma contains an active substance called dexmedetomidine, which belongs to a medicine group called sedatives. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.
2. What you need to know before you are given Dexmedetomidine EVER Pharma
You must not be given Dexmedetomidine EVER Pharma:
- if you are allergic to dexmedetomidine or any of the other ingredients of this medicine (listed in section 6).
- if you have some disorders of heart rhythm (heart block grade 2 or 3).
- if you have very low blood pressure which does not respond to treatment.
- if you have recently had a stroke or other serious condition affecting blood supply to the brain. Warnings and precautions
Before you are given this medicine, tell your doctor or nurse if any of the following apply as Dexmedetomidine EVER Pharma should be used cautiously:
- if you have an abnormally slow heart rate (either due to illness or high levels of physical fitness) as it may increase the risk for cardiac arrest
- if you have low blood pressure
- if you have low blood volume, for example after bleeding
- if you have certain heart disorders
- if you are elderly
- if you have a neurological disorder (for instance head or spinal cord injury or stroke)
- if you have severe liver problems
if you have ever developed a serious fever after some medicines, especially anesthetics An increased mortality risk has been seen for patients 65 years of age and under when using this medicine, especially for patients admitted to the intensive care unit for other reasons than after surgery with a more severe disease condition on admission to the intensive care unit and with a younger age. The doctor will decide if this medicine is still suitable for you. The doctor will take into account the benefit and risks of this medicine for you, compared to treatment with other sedatives.
This medicine may cause large amounts of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information.
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 may enhance the effect of Dexmedetomidine EVER Pharma:
- medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
- strong pain medicines (e.g. opioids such as morphine, codeine)
- anesthetic medicines (e.g. sevoflurane, isoflurane)
If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexmedetomidine EVER Pharma may enhance this effect. Dexmedetomidine EVER Pharma should not be used with medicines that cause temporary paralysis.
Pregnancy and breast-feeding
Dexmedetomidine EVER Pharma should not be used during pregnancy or breast-feeding unless clearly necessary.
Ask your doctor for advice before having this medicine.
Driving and using machines
Dexmedetomidine EVER Pharma has major impact on the ability to drive and use machines. After you have been given Dexmedetomidine EVER Pharma you must not drive, operate machinery, or work in dangerous situations until the effects are completely gone. Ask your doctor when you can start doing these activities again and when you can go back to this kind of work.
Dexmedetomidine EVER Pharma contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
3. How Dexmedetomidine EVER Pharma will be given
Hospital intensive care
Dexmedetomidine EVER Pharma is administered to you by a doctor or nurse in hospital intensive care. Procedural sedation/awake sedation
Dexmedetomidine EVER Pharma is administered to you by a doctor or nurse prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation. Your doctor will decide on a suitable dose for you. The amount of Dexmedetomidine EVER Pharma depends on your age, size, general condition of health, the level of sedation needed and how you respond to the medicine. Your doctor may change your dose if needed and will monitor your heart and blood pressure during the treatment.
Dexmedetomidine EVER Pharma is diluted and it is given to you as an infusion (drip) into your veins.
After sedation/wake-up
- The doctor will keep you under medical supervision for some hours after the sedation to make sure that you feel well.
- You should not go home unaccompanied.
Medicines to help you sleep, cause sedation or strong painkillers may not be appropriate for some time after you have been given Dexmedetomidine EVER Pharma. Talk to your doctor about the use of these medicines and about the use of alcohol.
If you have been given more Dexmedetomidine EVER Pharma than you should
If you are given too much Dexmedetomidine EVER Pharma, your blood pressure may go up or down, your heartbeat may slow down, 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 further questions on the use of this medicine, ask your doctor.
The following information is intended for healthcare professionals only:
Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion Method of administration
Dexmedetomidine EVER Pharma should be administered by healthcare professionals skilled in the management of patients requiring intensive care or in the anaesthetic management of patients in the operating room. It must be administered only as a diluted intravenous infusion using a controlled infu-sion device.
Preparation of solution
Dexmedetomidine EVER Pharma can be diluted in glucose 50 mg/ml (5%), Ringers, mannitol or sodium chloride 9 mg/ml (0.9%) solution for injection to achieve the required concentration of either 4 micro-grams/ml or 8 micrograms/ml prior to administration. Please see below in tabulated form the volumes needed to prepare the infusion.
In case the required concentration is 4 micrograms/ml:
Volume of Dexmedetomidine EVER Pharma 100 micrograms/ml
concentrate for solution for infusion
Volume of diluent Total volume of infusion
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 case the required concentration is 8 micrograms/ml:
Volume of Dexmedetomidine EVER Pharma 100 micrograms/ml
concentrate for solution for infusion
Volume of diluent Total volume of infusion
4 ml 46 ml 50 ml 8 ml 92 ml 100 ml 20 ml 230 ml 250 ml 40 ml 460 ml 500 ml Layout Management
Neutral template version: 21.03.2024
Date / version: 22.10.2024 / 11.0_v1
Packaging type: Leaflet
Dimension / size: 148 x 594 mm || pre folded: 148 x 297 mm
Material / product name: Dexmedetomidine
Country: UK
Customer: EVER Valinject GmbH
Item number customer: Xxxx
Item number EVJ: Xxxx
Print colors: Black
Item No. customer
Item No. EVJ
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
- change in breathing pattern or stopping breathing
Common (may affect up to 1 in 10 people)
- chest pain or heart attack
- fast heart rate
- low or high blood sugar
- 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
- swelling of the stomach
- thirst
- a condition where there is too much acid in the body
- low albumin level in blood
- shortness of breath
- hallucinations
- transient cessation of respiration
- the medicine is not effective enough
Not known (frequency cannot be estimated from the available data)
- large amounts of urine and excessive thirst – may be symptoms of a hormonal disorder called diabetes insipidus. Contact a doctor if these occur.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). 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 which is stated on the label and carton after EXP. This medicine does not require any special temperature storage conditions. Keep the ampoules or vials in the outer carton in order to protect from light.
6. Contents of the pack and other information
What Dexmedetomidine EVER Pharma contains
- The active substance is dexmedetomidine.
Each ml of concentrate contains dexmedetomidine hydrochloride equivalent to
100 micrograms 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 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
2, 5 or 10 ml colourless glass ampoules
2, 5 or 10 ml colourless glass vials
Pack sizes
5 x 2 ml ampoules
25 x 2 ml ampoules
4 x 4 ml ampoules
5 x 4 ml ampoules
4 x 10 ml ampoules
5 x 10 ml ampoules
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 am Attersee
Austria
Manufacturer:
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany
This leaflet was last revised in July 2023.
The solution should be shaken gently to mix well.
Dexmedetomidine EVER Pharma should be inspected visually for particulate matter and discoloration prior to administration.
Dexmedetomidine EVER Pharma has been shown to be compatible when administered with the following intravenous fluids and medicinal products:
Lactated Ringers, 5% glucose solution, sodium chloride 9 mg/ml (0.9%) solution for injection, mannitol 200 mg/ml (20%), thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succi-nylcholine, atracurium besylate, mivacurium chloride, rocuronium bromide, glycopyrrolate bromide, phenylephrine HCl, atropine sulfate, dopamine, noradrenaline, dobutamine, midazolam, morphine sulfate, fentanyl citrate, and a plasma-substitute.
Compatibility studies have shown potential for adsorption of dexmedetomidine to some types of natural rubber. Although dexmedetomidine is dosed to effect, it is advisable to use components with synthetic or coated natural rubber gaskets.
Shelf life
After dilution:
Chemical and physical stability of the diluted infusion (Infusion Solution Stability) has been demonstrated for 48 hours at 25°C and at refrigerated conditions (2 °C – 8 °C).
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the use are the responsibility of the user and would not normally be longer than 24 hours at 2° to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.