PRECEDEX READY TO USE dexmedetomidine hydrochloride 400 micrograms/100 mL injection for intravenous infusion bottle

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

dexmedetomidine hydrochloride, Quantity: 4.72 microgram/mL (Equivalent: dexmedetomidine, Qty 4 microgram/mL)

Доступна з:

Pfizer Australia Pty Ltd

ІПН (Міжнародна Ім'я):

dexmedetomidine hydrochloride

Фармацевтична форма:

Injection, intravenous infusion

Склад:

Excipient Ingredients: sodium chloride; water for injections

Адміністрація маршрут:

Intravenous Infusion

Одиниць в упаковці:

10 bottles

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

Intensive Care Unit (ICU) Sedation: For sedation of initially intubated adult patients during treatment in an intensive care setting. The use of PRECEDEX READY TO USE 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.

Огляд продуктів:

Visual Identification: Clear, colourless solution, free from visible particulates; Container Type: Bottle; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизація:

Licence status A

Дата Авторизація:

2015-12-09

інформаційний буклет

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

Характеристики продукта

______________________________________________________________________________________________________________
Version: pfppreri10921
Supercedes: pfppreri10421
1
AUSTRALIAN PRODUCT INFORMATION –
PRECEDEX
® READY TO USE
(DEXMEDETOMIDINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRECEDEX READY TO USE is a sterile, non-pyrogenic solution suitable
for intravenous
(IV) infusion.
Each 1 mL of PRECEDEX READY TO USE contains 4.72 micrograms of
dexmedetomidine
HCl (equivalent to 4 micrograms dexmedetomidine base) and 9 mg of
sodium chloride in water
for injections. The solution is preservative-free and contains no
additives or chemical
stabilisers.
3.
PHARMACEUTICAL FORM
PRECEDEX READY TO USE dexmedetomidine hydrochloride 4 micrograms/mL is
supplied
as a clear, colourless, isotonic solution with a pH of 4.5 to 8.0.
PRECEDEX READY TO USE
is presented in 20 mL vials, and 50 mL or 100 mL glass bottles, and
DOES NOT REQUIRE
DILUTION 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 READY TO USE 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.
______________________________________________________________________________________________________________
Version: pfppreri10921
Supercedes: pfppreri10421
2
Clinically significant events of bradycardia and sinus arrest have
been associated with
dexmedetomidine hydrochloride administration in young, healthy
volunteers with high vagal
tone
or
with
diffe