DEXMEDETOMIDINE SANDOZ dexmedetomidine (as hydrochloride) 200 microgram/2 mL concentrated injection vial

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

dexmedetomidine hydrochloride, Quantity: 118 microgram/mL

Disponible desde:

Sandoz Pty Ltd

formulario farmacéutico:

Injection, intravenous infusion

Composición:

Excipient Ingredients: water for injections; sodium chloride

Vía de administración:

Intravenous Infusion

Unidades en paquete:

25 vials

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: A clear, colorless solution in 2 mL clear glass vials, sealed with 13 mm coated stoppers, and secured with orange aluminum flip-off seals; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Registered

Fecha de autorización:

2018-10-11

Información para el usuario

210609-Dexmedetomidine Sandoz
1
DEXMEDETOMIDINE
SANDOZ
®
_Dexmedetomidine (dex-med-e-toh-med-een) hydrochloride _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dexmedetomidine
Sandoz. 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 Sandoz 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
SANDOZ IS USED FOR
_INTENSIVE CARE SEDATION _
Dexmedetomidine Sandoz can be
used as a sedative (calming agent) if
adults need to 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 Sandoz 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
action 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 Sandoz is only
available with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
DEXMEDETOMIDINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DEXMEDETOMIDINE
SANDOZ 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 CHI

Ficha técnica

210609-Dexmedetomidine Sandoz-pi
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
DEXMEDETOMIDINE SANDOZ (DEXMEDETOMIDINE HYDROCHLORIDE)
CONCENTRATED INJECTION
1.
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The
active
ingredient
in
DEXMEDETOMIDINE
SANDOZ
is
dexmedetomidine
(as
dexmedetomidine hydrochloride).
DEXMEDETOMIDINE SANDOZ is a sterile, non-pyrogenic solution suitable
for intravenous
infusion.
Each
2
mL
of
DEXMEDETOMIDINE
SANDOZ
contains
236
microgram
of
dexmedetomidine hydrochloride (equivalent to 200 microgram
dexmedetomidine base) and 18
mg of sodium chloride in water for injections.
The solution is preservative-free and contains no additives or
chemical stabilisers.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
DEXMEDETOMIDINE SANDOZ dexmedetomidine hydrochloride 100 microgram/mL
is
supplied as clear, colourless, isotonic solutions with a pH of 4.5 to
7.0. DEXMEDETOMIDINE
SANDOZ is presented in a 2 mL vial, 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 SANDOZ 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
DOSAGE
_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.
210609-Dexmed