DEXMEDETOMIDINE ACCORD dexmedetomidine (as hydrochloride) 200 micrograms/2 mL injection vial

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

dexmedetomidine hydrochloride, Quantity: 118 microgram/mL (Equivalent: dexmedetomidine, Qty microgram/mL)

Sẵn có từ:

Accord Healthcare Pty Ltd

Dạng dược phẩm:

Injection, concentrated

Thành phần:

Excipient Ingredients: sodium chloride; water for injections

Tuyến hành chính:

Intravenous

Các đơn vị trong gói:

1, 5, 25

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

ICU Sedation: For sedation of initially intubated adult patients during treatment in an intensive care setting. The use of Dexmedetomidine Accord 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.

Tóm tắt sản phẩm:

Visual Identification: A clear, colourless solution in a glass vial.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2019-06-18

Tờ rơi thông tin

Version 2.0
Page 1 of 3
DEXMEDETOMIDINE ACCORD
_Dexmedetomidine (as hydrochloride) Concentrated Injection 200
micrograms/2 mL _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dexmedetomidine
Accord.
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 Accord
against the benefits they expect it will
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT DEXMEDETOMIDINE
ACCORD IS USED FOR
_INTENSIVE CARE SEDATION _
Dexmedetomidine Accord 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 Accord 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 Accord is only
available with a doctor’s prescription.
BEFORE YOU ARE GIVEN
DEXMEDETOMIDINE
ACCORD
_WHEN YOU MUST NOT BE _
_GIVEN IT _
DO NOT TAKE DEXMEDETOMIDINE
ACCORD 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

Đặc tính sản phẩm

Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
DEXMEDETOMIDINE ACCORD (DEXMEDETOMIDINE
HYDROCHLORIDE) CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexmedetomidine Accord concentrated injection 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
Accord contains 236 micrograms of dexmedetomidine hydrochloride
(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 Accord is a clear, colourless, isotonic solution with
a pH of 4.5 to 7.0.
Dexmedetomidine Accord is presented in 2 mL vials and must be diluted
prior to use.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ICU SEDATION
For sedation of initially intubated patients during treatment in an
intensive care setting. The use of
Dexmedetomidine Accord 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
D
OSE 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 tone or with different routes
of
administration
including
rapid
intravenous
or
bolus
administration
of
dexmedetomidine
hydrochloride.
_Adults_
: Dexmedetomidine should be individualised and titrated to the desired
clinical effect.