DEXDOR dexmedetomidine (as hydrochloride) 200 micrograms/2 mL concentrated injection ampoule

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

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

Tillgänglig från:

Orion Pharma (AUS) Pty Limited

Läkemedelsform:

Injection, concentrated

Sammansättning:

Excipient Ingredients: sodium chloride; water for injections

Administreringssätt:

Intravenous Infusion

Enheter i paketet:

5 x 2mL ampoules, 25 x 2mL ampoules

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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

Produktsammanfattning:

Visual Identification: Clear, colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2022-11-14

Bipacksedel

DEXDOR CMI
1
DEXDOR®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN DEXDOR?
DEXDOR contains the active ingredient dexmedetomidine hydrochloride.
DEXDOR is used in adult patients who need to be
kept calm or sleepy when either:
•
on a breathing machine (ventilator) in the Intensive Care Unit (ICU),
or
•
unaided by a breathing machine before a surgical or other procedure.
For more information, see Section 1. Why am I being given DEXDOR? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN DEXDOR?
Do not use if you have ever had an allergic reaction to DEXDOR or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given DEXDOR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DEXDOR and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS DEXDOR GIVEN?
DEXDOR is diluted with another liquid in an IV bag and given as a
‘drip’ through a vein (intravenous infusion) by a doctor or
nurse. Your doctor or anaesthetist will decide how fast the infusion
will be given to keep you at the right depth of sleep or
calmness, and how long you need it.
More information can be found in Section 4. How is DEXDOR given? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN DEXDOR?
THINGS YOU
SHOULD DO
•
While DEXDOR is only given when you are in the ICU or surgery, some of
it may remain in the body for
a short time afterwards. Tell your doctor straight away that you have
been given DEXDOR before you
start a new medicine, undergo further surgery or blood tests since
these may be affected by DEXDOR.
•
Tell your doctor if you find out that yo

Produktens egenskaper

Product Information - Australia
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION –
DEXDOR®
[DEXMEDETOMIDINE (AS HYDROCHLORIDE)] CONCENTRATED INJECTION
1. NAME OF THE MEDICINE
Dexmedetomidine (as hydrochloride)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
200 MICROGRAM/2 ML: Each 2 mL ampoule of DEXDOR contains 236
micrograms of dexmedetomidine
hydrochloride (equivalent to 200 micrograms dexmedetomidine base).
400 MICROGRAM/4 ML: Each 4 mL vial of
DEXDOR contains 472 micrograms of
dexmedetomidine
hydrochloride (equivalent to 400 micrograms dexmedetomidine base).
1000 MICROGRAM/10 ML: Each 10 mL vial of DEXDOR contains 1180
micrograms of dexmedetomidine
hydrochloride (equivalent to 1000 micrograms dexmedetomidine base).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
DEXDOR dexmedetomidine (as hydrochloride) concentrated injection is a
sterile, non-pyrogenic solution
suitable for intravenous (IV) infusion.
DEXDOR concentrated injection is supplied as a clear, colourless,
isotonic solution with a pH of 4.5-7.0. It
is presented in 2 mL ampoule, 4 mL vial or 10 mL vial, and must be
diluted 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
DEXDOR 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 ra