Patient leaflet - Dexmedetomidine 8 micrograms/ml solution for infusion
1. WHAT DEXMEDETOMIDINE IS AND WHAT IT IS USED FOR
Dexmedetomidine 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
You must not be given Dexmedetomidine:
- 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 have this medicine Dexmedetomidine, tell your doctor or nurse if any of the following apply as Dexmedetomidine 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 anaesthetics
This medicine may cause large amount of urine and excessive thirst, contact a doctor if these side effects occur. See section 4 for more information. 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.
Other medicines and Dexmedetomidine
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
- medicines that help you sleep or cause sedation (e.g. midazolam, propofol)
- strong pain medicines (e.g. opioids such as morphine, codeine)
- anaesthetic medicines (e.g. sevoflurane, isoflurane)
If you are using medicines which lower your blood pressure and heart rate, co-administration with Dexmedetomidine may enhance this effect. Dexmedetomidine should not be used with medicines that cause temporary paralysis.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Dexmedetomidine should not be used during pregnancy or breast-feeding unless clearly necessary.
Driving and using machines
Dexmedetomidine has major impact on the ability to drive and use machines. After you have been given Dexmedetomidine 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 contains sodium.
Each bag of 50 ml contains 177 mg sodium (main component of cooking/table salt). This is equivalent to 8.9% of the recommended maximum daily dietary intake of sodium for an adult.
Each bag of 100 ml contains 354 mg sodium (main component of cooking/table salt). This is equivalent to 17.7% of the recommended maximum daily dietary intake of sodium for an adult.
Each bag of 250 ml contains 885 mg sodium (main component of cooking/table salt). This is equivalent to 44.3% of the recommended maximum daily dietary intake of sodium for an adult.
3. HOW TO USE DEXMEDETOMIDINE
Hospital intensive care
Dexmedetomidine is administered to you by a doctor or nurse in hospital intensive care. Your doctor will decide on a suitable dose for you.
Procedural sedation/awake sedation
Dexmedetomidine 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 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 is given to you as an infusion (drip) into your veins.
- Maximum dose: The maximum dose of 1.4 micrograms/kg/h should not be exceeded. Patients failing to achieve an adequate level of sedation with the maximum dose of dexmedetomidine should be switched to an alternative sedative agent.
- Indication 2. For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
- Initiation of Procedural Sedation: A loading infusion of 1.0 microgram/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 micrograms/kg given over 10 minutes may be suitable
- Maintenance of Procedural Sedation: The maintenance infusion is generally initiated at 0.6-0.7 microgram/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 microgram/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.
Shelf life:
The solution for infusion should be used immediately, after first opening. 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 taking Dexmedetomidine. Talk to your doctor about the use of these medicines and about the use of alcohol.
If you have been given more Dexmedetomidine than you should
If you are given too much Dexmedetomidine 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.
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
- the medicine is not effective enough
Not known (frequency cannot be estimated from the available data)
- large amount 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DEXMEDETOMIDINE
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Do not use this medicine after the expiry date which is stated on the bag. The expiry date refers to the last day of that month.
Your doctor, nurse or pharmacist knows how to store Dexmedetomidine properly (see section 6). After first opening, Dexmedetomidine should preferably be used immediately.
Do not throw away any medicines via wastewater.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Dexmedetomidine contains
- The active substance of Dexmedetomidine 4 microgram/ml and 8 microgram/ml solution for infusion is dexmedetomidine.
Dexmedetomidine 4 micrograms/ml
- Each ml contains dexmedetomidine hydrochloride equivalent to 4 micrograms dexmedetomidine.
Dexmedetomidine 8 micrograms/ml
- Each ml contains dexmedetomidine hydrochloride equivalent to 8 micrograms dexmedetomidine.
- The other ingredients are sodium chloride and water for injections.
What Dexmedetomidine looks like and contents of the pack
Dexmedetomidine is supplied as a solution in a clear, colorless bag.
Dexmedetomidine 4 micrograms/ml
One bag contains 50 ml or 100 ml or 250 ml solution.
Dexmedetomidine is supplied as
- 50 ml solution in a 50 ml flexible Polypropylene bag with an aluminium overpouch
- 100 ml solution in a 100 ml flexible Polypropylene bag with an aluminium overpouch
- 250 ml solution in a 250 ml flexible Polypropylene bag with an aluminium overpouch
Dexmedetomidine 8 micrograms/ml
One bag contains 250 ml solution.
Dexmedetomidine is supplied as
- 250 ml solution in a 250 ml flexible Polypropylene bag with an aluminium overpouch
Each Polypropylene bag contains a single port that is secured with a twist-off closure.
Pack sizes:
10 x 50 ml, 10 x 100 ml, 10 x 250 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença
2705-906 Terrugem SNT
Portugal
This leaflet was last revised in July 2024
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