Patient leaflet - Dexmedetomidine Altan 100 micrograms / ml concentrate for solution for infusion
what it is used for
Dexmedetomidine contains an activ which belongs to a medicine group sedation (a state of calm, drowsines intensive care settings or awake s surgical procedures.
e substance called Dexmedetomidine called sedatives. It is used to provide s or sleep) for adult patients in hospital edation during different diagnostic or
2. What you need to know before
you are given Dexmedetomidine:
You must not be given Dexmedeto
midine:
if you are allergic to Dexmedetom this medicine (listed in section 6).
idine or any of the other ingredients of
if you have some disorders of hea
rt rhythm (heart block grade 2 or 3). e which does not respond to treatment. r other serious condition affecting blood
- if you have very low blood pressur
- if you have recently had a stroke o supply to the brain.
Warnings and precautions
Before you are given this medicine, following apply as Dexmedetomidine
tell your doctor or nurse if any of the should be used cautiously:
if you have an abnormally slow h levels of physical fitness) as it may
eart rate (either due to illness or high increase the risk for cardiac arrest
- if you have low blood pressure
if you have low blood volume, for e
xample after bleeding
- if you have certain heart disorders
- if you are elderly
if you have a neurological disorder or stroke)
(for instance head or spinal cord injury
- if you have severe liver problems
if you have ever developed a especially anaesthetics
serious fever after some medicines,
This medicine may cause large a contact a doctor if these side eff information.
mount of urine and excessive thirst, ects occur. See section 4 for more
An increased risk of mortality has be and younger when using this medic the intensive care unit for reasons ot severe illness on admission to the age. The doctor will decide if this me will consider the benefits and risks with treatment with other sedatives.
en observed in patients 65 years of age ation, especially in patients admitted to her than postoperative care, with more care unit intensive and with a younger dicine is still suitable for you. The doctor of this medicine for you, in comparison
Other medicines and Dexmedetom
idine
Tell your doctor or nurse if you are ta any other medicines.
king, have recently taken or might take
The following medicines may enhan
ce the effect of Dexmedetomidine or cause sedation (e.g. midazolam,
- medicines that help you sleep propofol)
strong pain medicines (e.g. opioid
s such as morphine, codeine)
anaesthetic medicines (e.g. sevofl
urane, isoflurane)
If you are using medicines which lower co-administration with Dexmedetom Dexmedetomidine should not be used paralysis.
your blood pressure and heart rate, idine may enhance this effect. with medicines that cause temporary
Pregnancy, breast-feeding and fertili
ty
Dexmedetomidine should not be used unless clearly necessary.
during pregnancy or breast-feeding
Ask your doctor or pharmacist for advic
e before taking this medicine.
Driving and using machines
Dexmedetomidine has major impact machines.
on the ability to drive and use
After you have been given Dexmedet machinery, or work in dangerous situat start doing these activities again and w work.
omidine you must not drive, operate ions. Ask your doctor when you can hen you can go back to this kind of
Dexmedetomidine contains sodium
This medicine contains less than 1 mm is to say essentially `sodium-free´.
ol sodium (23 mg) per ampoule, that
This medicine contains 37 mg sodium salt) in each 10 mL vial. This is equ maximum daily dietary intake of sodium
(main component of cooking/table ivalent to 2% of the recommended for an adult.
3. How to use Dexmedetomidine
Hospital intensive care
Dexmedetomidine is administered to y intensive care.
ou by a doctor or nurse in hospital
Procedural sedation/awake sedation
Dexmedetomidine is administered to yo during diagnostic or surgical pro procedural/awake sedation.
u by a doctor or nurse prior to and/or cedures requiring sedation, i.e.
Your doctor will decide on a suitab Dexmedetomidine depends on your ag the level of sedation needed and how doctor may change your dose if need blood pressure during the treatment.
le dose for you. The amount of e, size, general condition of health, you respond to the medicine. Your ed and will monitor your heart and
Dexmedetomidine is diluted and it is g your veins.
iven to you as an infusion (drip) into
After sedation/wake-up
The doctor will keep you under medi the sedation to make sure that you fe
cal supervision for some hours after el well.
You should not go home unaccompa
nied.
Medicines to help you sleep, cause not be appropriate for some ti Dexmedetomidine. Talk to your doct and about the use of alcohol.
sedation or strong painkillers may me after you have been given or about the use of these medicines
If you have been given more Dexme
detomidine than you should
If you are given too much Dexmedeto
midine, your blood pressure may go up or down, your heartbeat may slow and you may feel more drowsy. Your do on your condition.
down, you may breathe more slowly, ctor will know how to treat you based
If you have any further questions on doctor.
the use of this medicine, ask your
4. Possible side effects
Like all medicines, this medicine ca everybody gets them.
n cause side effects, although not
Very common (affects more than 1 u
ser in 10)
- slow heart rate
- low or high blood pressure
change in breathing pattern or stoppi
ng breathing
Common (affects 1 to 10 users in 10
0)
- chest pain or heart attack
- fast heart rate
- low or high blood sugar
- nausea, vomiting or dry mouth
- restlessness
symptoms after stopping the medic
ine
- high temperature
Uncommon (affects 1 to 10 users
in 1,000)
a condition where there is too muc
h acid in the body
- low albumin level in blood
- shortness of breath
- hallucinations
reduced heart function, cardiac arr
est
the medicine is not effective enoug
h
- swelling of the stomach
- thirst
Not known (frequency cannot be e
stimated from the available data)
large amount of urine and exces hormonal disorder called diabetes occur.
sive thirst – may be symptoms of a insipidus. Contact a doctor if these
Reporting of side effects
If you get any side effects, talk to includes any possible side effects
your doctor, pharmacist or nurse. This not listed in this leaflet. You can also
report side effects directly via the Scheme Website: www.mhra.gov.uk Card in the Google Play or Apple A can help provide more information o
national reporting system Yellow Card /yellowcard or search for MHRA Yellow pp Store. By reporting side effects you n the safety of this medicine.
5. How to store Dexmedetomidine
Keep this medicine out of the sight a
nd reach of children.
Do not use this medicine after the e and carton after EXP.
xpiry date which is stated on the label
This medicine does not require any s Keep the ampoules and vials in the o
pecial temperature storage conditions. uter carton in order to protect from light.
6. Contents of the pack and other
information
What Dexmedetomidine contains
The active substance is Dexmed contains Dexmedetomidine hydroch Dexmedetomidine.
etomidine. Each mL of concentrate loride equivalent to 100 micrograms of
The other ingredients are sodium adjustment), hydrochloric acid (for p
chloride, sodium hydroxide (for pH H adjustment) and water for injections.
Each 2 mL ampoule contains 2 (as hydrochloride).
00 micrograms of Dexmedetomidine
Each 4 mL vial contains 400 (as hydrochloride).
micrograms of dexmedetomidine
Each 10 mL vial contains 100 (as hydrochloride).
0 micrograms of dexmedetomidine
The concentration of the final sol 4 micrograms/mL or 8 micrograms/m
ution after dilution should be either L.
What Dexmedetomidine looks like
and contents of the pack
Concentrate for solution for infusion The concentrate is a clear, colourles
(sterile concentrate). s solution.
Containers
2 mL glass ampoules
6 or 10 mL glass vials
Pack sizes
5 x 2 mL ampoules
25 x 2 mL ampoules
4 x 4 mL vials
4 x 10 mL vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Altan Pharmaceuticals, S.A. C/ Cólquide Nº 6, Portal 2, 1ª Planta Oficina F. Edificio Prisma
,
Las Rozas, 28230 Madrid,
Spain
Manufacturer Responsible for Batch Altan Pharmaceuticals, S.A.
Release:
Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal, Casarrubios del Monte, 45950 Toledo –
Spain
This leaflet was last revised in 09/20
25
Detailed information on this medicin MS/Agency
e is available on the website of
----------------------------------------------------The following information is intended fo
-----------------------------------------------r healthcare professionals only:
Dexmedetomidine 100 micrograms infusion
/mL concentrate for solution for
Method of administration
Dexmedetomidine should be admini skilled in the management of patient anaesthetic management of patients i diagnostic procedures. It must be admi
stered by healthcare professionals s requiring intensive care or in the n the operating room or undergoing nistered only as a diluted intravenous infusion using a controlled infusion dev
ice.
Preparation of solution
Dexmedetomidine can be diluted in mannitol or sodium chloride 9 mg/mL (0 the required concentration of either 4 prior to administration. Please see be needed to prepare the infusion.
glucose 50 mg/mL (5%), Ringers, .9%) solution for injection to achieve micrograms/mL or 8 micrograms/mL low in tabulated form the volumes
In the case the required concentrati
on is 4 micrograms/mL:
Volume of
Dexmedetomidine
100 micrograms/mL
concentrate for solution for infusion
Volume
of diluent
Total volume of infusion
2 mL 4 4 mL 9 10 mL 24 20 mL 48
8 mL
6 mL
0 mL
0 mL
50 mL
100 mL
250 mL
500 mL
In the case the required concentrati
on is 8 micrograms/mL:
Volume of
Dexmedetomidine
100 micrograms/mL
concentrate for solution for infusion
Volume
of diluent
Total volume of infusion
4 mL 4 8 mL 9 20 mL 23 40 mL 46
6 mL
2 mL
0 mL
0 mL
50 mL
100 mL
250 mL
500 mL
The solution should be shaken gently t
o mix well.
Dexmedetomidine should be inspecte
d visually for particulate matter and discoloration prior to administration.
Dexmedetomidine has been shown to with the following intravenous fluids an
be compatible when administered d medicinal products:
Lactated Ringers, 5% glucose solutio solution for injection, mannitol 200 m magnesium sulfate 10 mg/kg and 40 m
n, sodium chloride 9 mg/mL (0.9%) g/mL (20%), dexametasone 4 mg, g/kg, sufentanile 10 mcg/mL.
Shelf life
After dilution:
Chemical and physical stability of the Stability) has been demonstrated for 2 conditions (2°C – 8°C).
diluted infusion (Infusion Solution 4 hours at 25°C and at refrigerated
From a microbiological point of vi immediately. If not used immediately, prior to the use are the responsibility o longer than 24 hours at 2° to 8°C, controlled and validated aseptic conditi
ew, the product should be used in-use storage times and conditions f the user and would not normally be unless dilution has taken place in ons.