DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) 1000 micrograms/10 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dexmedetomidine hydrochloride, Quantity: 1180 microgram (Equivalent: dexmedetomidine, Qty 1000 microgram)

Available from:

Fresenius Kabi Australia Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous Infusion

Units in package:

5, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intensive Care Unit (ICU) Sedation,For sedation of initially intubated patients during treatment in an intensive care setting. The use of Dexmedetomidine Kabi by continuous infusion in these patients should not exceed 24 hours.,Procedural Sedation,For sedation of non-intubated patients prior to and/or during surgical and other procedures.

Product summary:

Visual Identification: The compound is a clear, colourless isotonic solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-11-23

Patient Information leaflet

Dexmedetomidine Kabi
1
DEXMEDETOMIDINE KABI
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN DEXMEDETOMIDINE KABI?
Dexmedetomidine Kabi contains the active ingredient dexmedetomidine
hydrochloride. Dexmedetomidine Kabi is used for:
Intensive Care Sedation
Dexmedetomidine Kabi can be used as a sedative (calming agent) if
adults need to be calm or sleepy in the Intensive Care Unit
whilst they are being ventilated (on a breathing machine). It may be
given as an infusion up to 24 hours.
Procedural Sedation
Dexmedetomidine Kabi can be given to adults prior to an operation if
they are not on a ventilator (breathing machine) if it is
required for the procedure or surgery that they be sleepy and calm.
For more information, see Section 1. Why am I being given
Dexmedetomidine Kabi? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DEXMEDETOMIDINE KABI?
Do not use if you have ever had an allergic reaction to
dexmedetomidine hydrochloride or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Dexmedetomidine Kabi? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dexmedetomidine Kabi and affect how
it works. These include:
•
medicines used to produce calmness or to help you sleep
•
strong pain relievers
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DEXMEDETOMIDINE KABI GIVEN?
Dexmedetomidine Kabi is diluted with another liquid in an IV bag and
given as a ‘drip’ through a vein (intravenous infusion) by
a doctor or nurse. Your doctor will decide how fast the infusion will
be given to keep you at the right depth of sleep or
calmness, and how l

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – DEXMEDETOMIDINE
KABI (DEXMEDETOMIDINE (AS HYDROCHLORIDE)) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Dexmedetomidine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
200 microgram/ 2 mL: Each 2 mL vial of DEXMEDETOMIDINE KABI contains
236 micrograms
of dexmedetomidine hydrochloride (equivalent to 200 micrograms
dexmedetomidine base).
400 microgram/ 4 mL: Each 4 mL vial of DEXMEDETOMIDINE KABI contains
472 micrograms
of dexmedetomidine hydrochloride (equivalent to 400 micrograms
dexmedetomidine base).
1000
microgram/
10
mL:
Each
10
mL
vial
of
DEXMEDETOMIDINE
KABI
contains
1180 micrograms
of
dexmedetomidine
hydrochloride
(equivalent
to
1000
micrograms
dexmedetomidine base).
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
DEXMEDETOMIDINE KABI dexmedetomidine (as hydrochloride) concentrated
injection is a
sterile, non-pyrogenic solution suitable for intravenous (IV)
infusion.
DEXMEDETOMIDINE KABI concentrated injection is supplied as
a clear, colourless isotonic
solution with a pH of 4.5 – 7.0. It is presented in 2 mL, 4 mL or 10
mL vials, and must be diluted
prior to use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intensive Care Unit (ICU) Sedation
For sedation of initially intubated patients during treatment in an
intensive care setting. The
use of DEXMEDETOMIDINE KABI by continuous infusion in these patients
should not exceed
24 hours.
Procedural Sedation
For sedation of non-intubated patients prior to and/or during surgical
and other procedures.
4.2
DOSE AND METHOD OF ADMINISTRATION
_NOTE: _Dexmedetomidine should be administered only by persons skilled
in anaesthetics or
in the management of patients in the intensive care setting. Due to
the known pharmacological
effects, patients should be continuously monitored.
Clinically significant events of bradycardia and sinus arrest have
been associated with
dexmedetomidine administration in young, healthy volunteers with high
vagal tone or with
different routes of a