TRANEXAMIC ACID LU 500 mg/ 5 mL tranexamic acid solution for injection ampoule
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
tranexamic acid, Quantity: 100 mg/mL
Available from:
Luminarie Pty Ltd
INN (International Name):
Tranexamic acid
Pharmaceutical form:
Injection, solution
Composition:
Excipient Ingredients: water for injections
Administration route:
Intravenous
Units in package:
5 x 5 mL ampoules
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: Clear, colorless solution for injection.; 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:
2014-08-05
Patient Information leaflet
1
TRANEXAMIC ACID LU
(TRAN-X-AMIC ACID LU)
_Tranexamic acid solution for injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
Please read this leaflet
carefully before you are
given TRANEXAMIC
ACID LU injection. This
leaflet answers some
common questions about
TRANEXAMIC ACID LU.
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
having an administration of
TRANEXAMIC ACID LU
against the expected benefits
it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT THE ADMINISTRATION OF
THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet you may need
to read it again.
WHAT TRANEXAMIC
ACID LU
IS USED FOR
TRANEXAMIC ACID LUis
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 LU WORKS
TRANEXAMIC ACID LU
contains tranexamic acid.
Tranexamic acid is an
antifibrinolytic that works by
slowing the processes that cause
bleeding.
BEFORE RECEIVING
TRANEXAMIC ACID LU
_WHEN YOU MUST NOT HAVE _
_AN ADMINISTRATION OF IT_
DO NOT HAVE AN
ADMINISTRATION OF
TRANEXAMIC ACID LU IF
YOU HAVE AN ALLERGY TO
TRANEXAMIC ACID LU OR
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET.
DO NOT HAVE AN
ADMINISTRATION OF
TRANEXAMIC ACID LU IF
YOU ARE BEING TREATED FOR A
STROKE.
DO NOT HAVE AN
ADMINISTRATION OF
TRANEXAMIC ACID LU IF
YOU ARE BEING TREATED FOR
BLOOD CLOTS IN YOUR LEGS,
LUNGS OR ANYWHERE ELSE IN
YOUR BODY.
DO NOT HAVE AN
ADMINISTRATION OF
TRANEXAMIC ACID LU IF
YOU HAVE A PROBLEM WITH
COLOUR VISION THAT DEVELOPED
AFTER YOU WERE BORN.
_BEFORE YOU ARE _
_ADMINISTERED IT _
YOU MUST TELL YOUR DOCTOR
BEFORE HE/HER ADMINISTERS
TRANEXAMIC ACID LU IF
YOU HAVE ANY OF THE
FOLLOWING:
•
you, or someone in your
family, has ever suffered
from blood clots
•
severe bruising
•
kidney disease with or
without blood in the urine
•
are pregnant or think y
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Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – TRANEXAMIC ACID
LU
(Tranexamic
acid)
1 NAME OF THE MEDICINE
Tranexamic acid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
TRANEXAMIC ACID LU Solution for Injection contains 100 mg/mL
tranexamic acid.
Tranexamic acid is a white crystalline powder that is odourless or
almost odourless. It is freely
soluble in water and in glacial acetic acid, practically insoluble in
methanol, ethanol, acetone,
diethyl ether and benzene.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Solution for Injection. Sterile, clear, colourless solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRANEXAMIC ACID LU is indicated in the treatment of;
INTRAVENOUS ADMINISTRATION
_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
INTRAVENOUS 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 LU, followed by infusion of 4.5 mg/kg/h
for the duration
of surgery. 0.6 mg/kg of this elder dose may be added in the priming
volume of the heart-
lung machine.
_ _
_ADULT TOTAL KNEE ARTHROPLASTY_
Administration of 15 mg/kg TRANEXAMIC ACID LU 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.
_ADULT TOTAL HIP ARTHROPLASTY_
Administration of 15mg/kg TRANEXAMIC ACID LU 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
PHARMACODYN
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