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

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

dexmedetomidine hydrochloride, Quantity: 118 microgram/mL (Equivalent: dexmedetomidine, Qty 100 microgram/mL)

Disponible depuis:

Alphapharm Pty Ltd

forme pharmaceutique:

Injection, concentrated

Composition:

Excipient Ingredients: nitrogen; water for injections; sodium chloride

Mode d'administration:

Intravenous Infusion

Unités en paquet:

1 vial, 5 vials, 25 vials

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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

Descriptif du produit:

Visual Identification: A clear, colourless, solution; 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

Statut de autorisation:

Registered

Date de l'autorisation:

2018-10-15

Notice patient

DEXMEDETOMIDINE
MYLAN
_Dexmedetomidine (dex-med-e-toh-med-een) (as the hydrochloride)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dexmedetomidine
Mylan. 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 Mylan
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
WHAT
DEXMEDETOMIDINE
MYLAN IS USED FOR
_INTENSIVE CARE SEDATION_
Dexmedetomidine Mylan can be
used as a sedative (calming agent) if
adults need to be calm or sleepy in
the Intensive Care Unit of a hospital
whilst they are being ventilated (on a
breathing machine). It may be given
as an infusion for up to 24 hours
whilst in a hospital.
_PROCEDURAL SEDATION_
Dexmedetomidine Mylan can be
given to adults prior to an operation
if they are not on a ventilator
(breathing machine) and if they are
required to be sleepy and calm for
the procedure or surgery performed
in a hospital.
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 Mylan is only
available with a doctor’s
prescription.
BEFORE YOU ARE GIVEN
DEXMEDETOMIDINE
MYLAN
_WHEN YOU MUST NOT USE IT_
DO NOT USE DEXMEDETOMIDINE
MYLAN 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

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
DEXMEDETOMIDINE MYLAN
_Dexmedetomidine (as hydrochloride) _
1
NAME OF THE MEDICINE
Dexmedetomidine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dexmedetomidine
Mylan
concentrated
injection
for
intravenous
infusion
contains
dexmedetomidine
(as
hydrochloride) 200 microgram/2 mL and is a sterile, non-pyrogenic,
isotonic solution with a pH of 4.5 to 7.0.
Each 1 mL of Dexmedetomidine Mylan contains 118 micrograms of
dexmedetomidine HCl (equivalent to 100
micrograms dexmedetomidine base) and 9 mg of sodium chloride in water.
The solution is preservative-free and
contains no additives or chemical stabilisers.
3
PHARMACEUTICAL FORM
Dexmedetomidine Mylan concentrated injection vial is supplied as a
clear, colourless, isotonic solution free from
visible particles. Dexmedetomidine Mylan is presented in a 2 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 Mylan 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 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.
ICU SEDATION
INITIATION
For adult patients, dexmedetomidine may be initiated with a loading
infusio