DEXMEDETOMIDINE MEDSURGE dexmedetomidine (as hydrochloride) 200 microgram/2 mL concentrated injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous Infusion

Units in package:

10 ampoules, 25 ampoules, 5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Clear, colourless or yellowish solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-11-11

Patient Information leaflet

DEXMEDETOMIDINE MEDSURGE
DEXMEDETOMIDINE HYDROCHLORIDE
Dexmedetomidine Medsurge CMI v2 July 2022
1
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 USING DEXMEDETOMIDINE MEDSURGE?
Dexmedetomidine Medsurge contains the active ingredient
Dexmedetomidine (as hydrochloride).
Dexmedetomidine is a relatively selective alpha2-adrenoreceptor
agonist with a broad range of pharmacologic properties.
ICU SEDATION
Dexmedetomidine Medsurge concentrated injection can be used for
sedation of initially intubated patients during treatment in
an intensive care setting. The use of Dexmedetomidine hydrochloride by
continuous infusion in these patients should not exceed
24 hours.
PROCEDURAL SEDATION
Dexmedetomidine Medsurge concentrated injection can be used for
sedation of non-intubated patients prior to and/or during
surgical and other procedures.
For more information, see Section 1. Why am I using Dexmedetomidine
Medsurge?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DEXMEDETOMIDINE MEDSURGE?
Do not use if you have ever had an allergic reaction to
Dexmedetomidine Hydrochloride 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 use
Dexmedetomidine Medsurge?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dexmedetomidine Medsurge 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 DO I USE DEXMEDETOMIDINE MEDSURGE?
•
Your doctor will decide what dose you will receive. This depends on
your condition and other factors such as your weight.
The dose will be adjusted to keep you at the right depth of sleep or
sedation.
•
Dexmedetomidine Medsurge concentrate

Summary of Product characteristics

DEXMEDETOMIDINE
_ _
PRODUCT INFORMATION
Dexmedetomidine Medsurge PI Edition 1 Nov 2021
Page
1
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AUSTRALIAN PRODUCT INFORMATION
DEXMEDETOMIDINE MEDSURGE
(DEXMEDETOMIDINE)
CONCENTRATED INJECTION
1
NAME OF THE MEDICINE
Dexmedetomidine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DEXMEDETOMIDINE MEDSURGE concentrated injection is a sterile,
non-pyrogenic solution suitable for
intravenous infusion.
Each 2 mL of dexmedetomidine (as hydrochloride) injection contains 236
micrograms of dexmedetomidine
hydrochloride (equivalent to 200 micrograms of dexmedetomidine base)
and 17.66 mg of sodium chloride in
Water for Injections.
Each 4 mL of dexmedetomidine (as hydrochloride) injection contains 472
micrograms of dexmedetomidine
hydrochloride (equivalent to 400 micrograms of dexmedetomidine base)
and 35.32 mg of sodium chloride in
Water for Injections.
Each 10 mL of dexmedetomidine (as hydrochloride) injection contains
1180 micrograms of dexmedetomidine
hydrochloride (equivalent to 1000 micrograms of dexmedetomidine base)
and 88.30 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
Concentrated injection.
DEXMEDETOMIDINE
MEDSURGE
dexmedetomidine
(as
hydrochloride)
100
microgram/mL
is
supplied as a sterile, clear and colourless or yellowish, isotonic
solution with a pH of 4.5 to 7.0.
DEXMEDETOMIDINE MEDSURGE is presented in a 2 mL ampoule, 4 mL vial or
10 mL vial and must
be diluted prior to use.
DEXMEDETOMIDINE
_ _
PRODUCT INFORMATION
Dexmedetomidine Medsurge PI Edition 1 Nov 2021
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2
of
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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 hydrochloride by continuous infusion in these patients
should not exceed 24 hours.
PROCEDURAL SEDATION
For sedation of non-intubated patients prior to and/or during s