DEXMEDETOMIDINE-TEVA dexmedetomidine (as HCl) 200 micrograms/2mL concentrated injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

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

Sẵn có từ:

Teva Pharma Australia Pty Ltd

Dạng dược phẩm:

Injection, concentrated

Thành phần:

Excipient Ingredients: sodium chloride; water for injections

Tuyến hành chính:

Intravenous Infusion

Các đơn vị trong gói:

25 vials, 5 vials

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

ICU Sedation,For sedation of initially intubated patients during treatment in an intensive care setting.,The use of dexmedetomidine 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.

Tóm tắt sản phẩm:

Visual Identification: Clear, colourless solution in 3 mL glass vials with grey teflon coated chlorobutyl rubber stoppers and Al caps fitted with green-blue flip off cover.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2018-10-23

Tờ rơi thông tin

DEXMEDETOMIDINE-
TEVA
®
_Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dexmedetomidine.
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 Dexmedetomidine 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.
You may need to read it again.
WHAT
DEXMEDETOMIDINE IS
USED FOR
_INTENSIVE CARE SEDATION_
Dexmedetomidine 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 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.
Dexmedetomidine is only available
with a doctor's prescription.
BEFORE YOU ARE GIVEN
DEXMEDETOMIDINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DEXMEDETOMIDINE 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 TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BRE

Đặc tính sản phẩm

DEXMEDETOMIDINE-TEVA
®
200 µg/2 mL concentrated injection
Page 1 of 22
Teva Pharma Australia Pty Ltd
Version 2.0
2019-04-18
AUSTRALIAN PI – DEXMEDETOMIDINE-TEVA
®
(DEXMEDETOMIDINE HYDROCHLORIDE) CONCENTRATED
INJECTION
1
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexmedetomidine-Teva is a sterile, non-pyrogenic solution suitable for
intravenous infusion.
Dexmedetomidine hydrochloride is a white or almost white powder,
freely soluble in water and
its pKa is 7.1. The partition coefficient in octanol: water at pH 7.84
is 2.89. Each 2 mL of
Dexmedetomidine-Teva 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
Dexmedetomidine-Teva dexmedetomidine (as hydrochloride) concentrated
injection 200
micrograms/2 mL is supplied as clear, colourless, isotonic solution
with a pH of 4.5 to 7.0.
Dexmedetomidine-Teva is presented in a 3 mL vial, and must be diluted
prior to use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ICU Sedation
For sedation of initially intubated patients during treatment in an
intensive care setting. The use
of dexmedetomidine 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.
Contains no antimicrobial agent. For single use in one patient only.
Discard any residue after
use.
Clinically significant events of bradycardia and sinus arrest have
been associated with
dexmedetomidine hydrochloride administration in young, healthy
volunteers wi