Dexmedetomidine Kabi 100 micrograms/mL concentrate for solution for infusion

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Dexmedetomidine hydrochloride

Inapatikana kutoka:

Fresenius Kabi Deutschland GmbH

ATC kanuni:

N05CM18

INN (Jina la Kimataifa):

Dexmedetomidine hydrochloride

Kipimo:

100 microgram(s)/millilitre

Dawa fomu:

Concentrate for solution for infusion

Eneo la matibabu:

dexmedetomidine

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2021-10-22

Taarifa za kipeperushi

UK-IE PIL-V003
3
1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXMEDETOMIDINE KABI 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 Dexmedetomidine Kabi is and what it is used for
2.
What you need to know before you are given Dexmedetomidine Kabi
3.
How to use Dexmedetomidine Kabi
4.
Possible side effects
5.
How to store Dexmedetomidine Kabi
6.
Contents of the pack and other information
1.
WHAT DEXMEDETOMIDINE KABI IS AND WHAT IT IS USED FOR
Dexmedetomidine Kabi 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 KABI
YOU MUST NOT BE GIVEN DEXMEDETOMIDINE KABI
-
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 Kabi 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 b

Tabia za bidhaa

Health Products Regulatory Authority
25 October 2022
CRN00D4G4
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexmedetomidine Kabi 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.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1000 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.
Osmolarity: approximately 290 mOsm/L.
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 Kabi 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
inf