PRECEDEX dexmedetomidine hydrochloride 200 micrograms/2mL injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

dexmedetomidine hydrochloride, Quantity: 236 microgram (Equivalent: dexmedetomidine, Qty 200 microgram)

थमां उपलब्ध:

Pfizer Australia Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, concentrated

रचना:

Excipient Ingredients: water for injections; sodium chloride

प्रशासन का मार्ग:

Intravenous

पैकेज में यूनिट:

5 x 2mL vials, 25 x 2mL vials

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2002-04-04

सूचना पत्रक

PRECEDEX®
PRECEDEX® READY
TO USE
_Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRECEDEX and
PRECEDEX READY TO USE
(collectively referred to as
PRECEDEX in this leaflet unless
stated otherwise). It does not contain
all the available information. It does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking PRECEDEX
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PRECEDEX IS
USED FOR
_INTENSIVE CARE SEDATION_
PRECEDEX 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_
PRECEDEX 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.
This medicine belongs to a group of
medicines called alpha-2-receptor
agonists.
This medicine works by its actions
on brain chemicals.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
PRECEDEX is available only with a
doctor's prescription.
BEFORE YOU ARE GIVEN
PRECEDEX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PRECEDEX IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
dexmedetomidine hydrochloride
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT GIVE THIS MEDICINE TO A CHILD
UNDER THE A

उत्पाद विशेषताएं

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Version: pfppreci10921
Supercedes: pfppreci10421
1
AUSTRALIAN PRODUCT INFORMATION –
PRECEDEX
® (DEXMEDETOMIDINE
HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRECEDEX concentrated injection is a sterile, non-pyrogenic solution
suitable for intravenous
(IV) infusion.
Each 2 mL of PRECEDEX contains 236 micrograms of dexmedetomidine HCl
(equivalent to
200 micrograms dexmedetomidine base) and 18 mg of sodium chloride in
water for injections.
The solution is preservative-free and contains no additives or
chemical stabilisers.
3.
PHARMACEUTICAL FORM
PRECEDEX (dexmedetomidine hydrochloride) 100 micrograms/mL is supplied
as clear,
colourless, isotonic solutions with a pH of 4.5 to 7.0. PRECEDEX is
presented in 2 mL vial
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 PRECEDEX 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 hydrochloride administration in young, healthy
volunteers with high vagal
______________________________________________________________________________________________________________
Version: pfppreci10921
Supercedes: pfppreci10421
2
tone
or
with
different
routes
of
administration
including
rapid
intravenous
or
bolus
administration of dexmedetomid