Dexdor

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Dexmedetomidine hydrochloride

Available from:

Orion Corporation

ATC code:

N05CM18

INN (International Name):

dexmedetomidine

Therapeutic group:

Psycholeptics

Therapeutic area:

Conscious Sedation

Therapeutic indications:

For sedation of adult intensive care unit patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3).

Product summary:

Revision: 16

Authorization status:

Authorised

Authorization date:

2011-09-15

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXDOR 100 MICROGRAMS/ML CONCENTRATE FOR SOLUTION FOR INFUSION
dexmedetomidine
READ ALL OF 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 further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Dexdor is and what it is used for
2.
What you need to know before you are given Dexdor
3.
How to use Dexdor
4.
Possible side effects
5.
How to store Dexdor
6.
Contents of the pack and other information
1.
WHAT DEXDOR IS AND WHAT IT IS USED FOR
Dexdor 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 DEXDOR
YOU MUST NOT BE GIVEN DEXDOR
-
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, tell your doctor or nurse if any of the
following apply as Dexdor
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 o

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dexdor 100 micrograms/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate contains dexmedetomidine hydrochloride
equivalent to 100 micrograms
dexmedetomidine.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1 000 micrograms of dexmedetomidine.
The concentration of the final solution after dilution should be
either 4 micrograms/ml or
8 micrograms/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution, pH 4.5–7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For sedation of adult ICU (Intensive Care Unit) patients requiring a
sedation level not deeper than
arousal in response to verbal stimulation (corresponding to Richmond
Agitation-Sedation Scale
(RASS) 0 to -3).
For sedation of non-intubated adult patients prior to and/or during
diagnostic or surgical procedures
requiring sedation, i.e. procedural/awake sedation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR SEDATION OF ADULT ICU (INTENSIVE CARE UNIT) PATIENTS REQUIRING A
SEDATION LEVEL NOT DEEPER
THAN AROUSAL IN RESPONSE TO VERBAL STIMULATION (CORRESPONDING TO
RICHMOND AGITATION-SEDATION
SCALE (RASS) 0 TO -3).
For hospital use only. Dexdor should be administered by healthcare
professionals skilled in the
management of patients requiring intensive care.
Posology
Patients already intubated and sedated may switch to dexmedetomidine
with an initial infusion rate of
0.7 micrograms/kg/h which may then be adjusted stepwise within the
dose range 0.2 to
1.4 micrograms/kg/h in order to achieve the desired level of sedation,
depending on the patient’s
response. A lower starting infusion rate should be considered for
frail patients. Dexmedetomid