TRANEXAMIC ACID JUNO tranexamic acid 1000 mg/10 mL solution for injection ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
02-08-2021
Summary of Product characteristics
(SPC)
02-08-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
tranexamic acid, Quantity: 1000 mg
Available from:
Juno Pharmaceuticals Pty Ltd
INN (International Name):
Tranexamic acid
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections
Administration route:
Intravenous
Units in package:
1, 10
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Adults For the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee arthroplasty or total hip arthroplasty. Paediatrics For the reduction of peri? and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery.
Product summary:
Visual Identification: It is a sterile, clear, colourless solution, practically free from visible particles.; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2015-03-02
Patient Information leaflet
_Doc ID #_
_ 3.JU.M.1.0 _
_Page 1 of 3_
TRANEXAMIC ACID JUNO
_Tranexamic Acid Solution for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Tranexamic Acid Juno. It does
not
contain
all
the
available
information and 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 being
treated
with
Tranexamic
Acid
Juno against the benefits it is
expected to have for you.
Please read this leaflet carefully
and follow the instructions given
to you by your doctor and the
advice contained in this leaflet.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT BEING TREATED WITH THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TRANEXAMIC ACID
JUNO IS USED FOR
Tranexamic Acid Juno Solution
for Injection is used to reduce
bleeding
and
the
need
for
transfusion of blood in patients
undergoing heart surgery, total
knee replacement and total hip
replacement surgery.
HOW TRANEXAMIC ACID
JUNO WORKS
Tranexamic Acid Juno contains
tranexamic
acid.
Tranexamic
acid
is
an
antifibrinolytic
that
works by slowing the processes
that cause bleeding.
BEFORE
TREATMENT
WITH
TRANEXAMIC ACID JUNO
_WHEN TRANEXAMIC ACID JUNO _
_MUST NOT BE USED_
Tranexamic Acid Juno must not
be used if you:
•
have an allergy to tranexamic
acid or any of the ingredients
listed at the end of this leaflet.
•
are being treated for stroke
•
are being treated for blood
clots in your legs, lungs or
anywhere else in your body.
•
have a problem with colour
vision
that
developed
after
you were born.
DO NOT USE TRANEXAMIC ACID
JUNO
AFTER
THE
EXPIRY
DATE
(EXP) PRINTED ON THE PACK.
Medicine taken after the expiry
date has passed may not work
as well.
DO NOT USE TRANEXAMIC ACID
JUNO IF THE PACKAGING IS TORN
OR SHOWS SIGNS OF TAMPERING.
DO NOT USE TRANEXAMIC ACID
JUNO
TO
TREAT
ANY
OTHER
COMPLAINT UNLESS YOUR DOCTOR
TELLS YOU TO.
_BEFORE _
_TREATMENT _
_WITH _
_TRANEXAMIC ACID JUNO_
TELL YOUR DO
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Summary of Product characteristics
Juno Pharmaceuticals Pty Ltd
Australian Product Information
AUSTRALIAN PRODUCT INFORMATION
TRANEXAMIC ACID JUNO (_TRANEXAMIC ACID_)
_ _
1
NAME OF THE MEDICINE
Tranexamic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL ampoule of Tranexamic Acid Juno solution for injection
contains 500 mg
tranexamic acid.
Each 10 mL ampoule of Tranexamic Acid Juno solution for injection
contains 1000 mg
tranexamic acid.
For the full list of excipients, see SECTION 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Tranexamic Acid Juno solution for injection is a sterile, clear,
colourless solution practically
free of visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
For the reduction of peri– and post-operative blood loss and the
need for blood transfusion
in patients undergoing cardiac surgery or total knee arthroplasty or
total hip arthroplasty.
PAEDIATRICS
For the reduction of peri– and post-operative blood loss and the
need for blood transfusion
in patients undergoing cardiac surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULT CARDIAC SURGERY
After induction of anaesthesia and prior to skin incision, administer
a pre-surgical loading
dose of 15 mg/kg tranexamic acid, followed by infusion of 4.5 mg/kg/h
for the duration of
surgery. 0.6 mg/kg of this infusion dose may be added in the priming
volume of the heart-
lung machine.
ADULT TOTAL KNEE ARTHROPLASTY
Administration of 15 mg/kg tranexamic acid prior to release of the
tourniquet followed by
repeat bolus injection of 15 mg/kg at 8 hourly intervals after the
initial dose. The last bolus
dose is to be administered 16 hours after the initial dose.
Juno Pharmaceuticals Pty Ltd
Australian Product Information
ADULT TOTAL HIP ARTHROPLASTY
Administration of 15mg/kg tranexamic acid immediately prior to skin
incision, followed by
a repeat bolus of 15 mg/kg at 8 hourly intervals after the initial
dose. The last bolus dose
is
to
be
administered
16
hours
after
the
initial
dose
(also
see
SECTION
5.1
PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
USE I
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