Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Dexmedetomidine hydrochloride

Commercializzato da:

Baxter Holding B.V.

Codice ATC:

N05CM18

INN (Nome Internazionale):

Dexmedetomidine hydrochloride

Dosaggio:

100 microgram(s)/millilitre

Forma farmaceutica:

Concentrate for solution for infusion

Area terapeutica:

dexmedetomidine

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2021-03-12

Foglio illustrativo

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXMEDETOMIDINE 100 MICROGRAMS/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
dexmedetomidine
The name of your medicine is Dexmedetomidine 100 micrograms/ml
concentrate for solution
for infusion which will be referred to as Dexmedetomidine throughout
this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Dexmedetomidine is and what it is used for
2.
What you need to know before you are given Dexmedetomidine
3.
How to use Dexmedetomidine
4.
Possible side effects
5.
How to store Dexmedetomidine
6.
Contents of the pack and other information
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, 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

Scheda tecnica

Health Products Regulatory Authority
13 April 2022
CRN00CTDY
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexmedetomidine 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 vial contains 200 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. Dexmedetomidine 100 micrograms/ml concentrate
for solution for infusion 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.
Dexmedetomidine is very potent and the infusion rate is given p