Dexmedetomidine Kabi 100 micrograms/mL concentrate for solution for infusion (4ml vial)

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

DEXMEDETOMIDINE

Boleh didapati daripada:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

Kod ATC:

N05CM18

INN (Nama Antarabangsa):

DEXMEDETOMIDINE 100 µg/ml

Borang farmaseutikal:

CONCENTRATE FOR SOLUTION FOR INFUSION

Komposisi:

DEXMEDETOMIDINE 100 µg/ml

Jenis preskripsi:

POM

Kawasan terapeutik:

PSYCHOLEPTICS

Ringkasan produk:

Licence number in the source country: NOT APPLICAPABLE

Status kebenaran:

Authorised

Tarikh kebenaran:

2021-08-16

Risalah maklumat

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 100 mcg/mL is and what it is used for
2.
What you need to know before you are given Dexmedetomidine Kabi 100
mcg/mL
3.
How to use Dexmedetomidine Kabi 100 mcg/mL
4.
Possible side effects
5.
How to store Dexmedetomidine Kabi 100 mcg/mL
6.
Contents of the pack and other information
1.
WHAT DEXMEDETOMIDINE KABI 100 MCG/ML IS AND WHAT IT IS USED FOR
Dexmedetomidine Kabi 100 mcg/mL 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 100
MCG/ML
YOU MUST NOT BE GIVEN DEXMEDETOMIDINE KABI 100 MCG/ML
-
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 100 mcg/mL 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 increas

Ciri produk

1
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 100 mcg/mL should be
administered by healthcare
professionals skilled in the management of patients requiring
intensive care.
Posology
2
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. Dex