ZAMIC tranexamic acid 500mg/5mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tranexamic acid, Quantity: 500 mg

Available from:

Medsurge Pharma Pty Ltd

INN (International Name):

Tranexamic acid

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid

Administration route:

Intravenous

Units in package:

5 packs of 5mL ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

Visual Identification: Clear, colourless solution, free from visible particles; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-04-23

Patient Information leaflet

ZAMIC CMI V3.0 (MARCH 2018)
1
ZAMIC
_TRANEXAMIC ACID _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
Please read this leaflet carefully before
you
start
taking
Zamic.
This
leaflet
answers some common questions about
Zamic.
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 Zamic against the expected
benefits it will have for you.
Use Zamic as instructed and follow the
advice given in this leaflet.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
Keep
this
leaflet
with
the
medicine.
You may need to read it again.
What Zamic injection is
used for
Zamic 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.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED
FOR YOU.
How Zamic works
Zamic
contains
tranexamic
acid.
Tranexamic acid is an antifibrinolytic
that works by slowing the processes
that cause bleeding.
Before taking Zamic
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ZAMIC IF YOU HAVE AN
ALLERGY
TO
ZAMIC
OR
ANY
OF
THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE ZAMIC IF YOU ARE BEING
TREATED FOR A STROKE.
DO NOT TAKE ZAMIC IF YOU ARE BEING
TREATED FOR BLOOD CLOTS IN YOUR LEGS,
LUNGS OR ANYWHERE ELSE IN YOUR BODY.
DO
NOT
TAKE
ZAMIC
IF
YOU
HAVE
A
PROBLEM
WITH
COLOUR
VISION
THAT
DEVELOPED AFTER YOU WERE BORN.
DO NOT TAKE ZAMIC AFTER THE EXPIRY
DATE (EXP) PRINTED ON THE PACK.
If
you
take
this
medicine
after
the
expiry date has passed, it may not work
as well.
DO NOT TAKE ZAMIC IF THE PACKAGING
IS TORN OR SHOWS SIGNS OF TAMPERING.
_BEFORE YOU START TO TAKE IT _
_ _
YOU MUST TELL YOUR DOCTOR ABOUT ALL
OF THE FOLLOWING BEFORE YOU START TO
TAKE ZAMIC:
•
if you or someone in your family
has ever suffered from blood clots
•
if you have severe bruising
•
if yo

Summary of Product characteristics

ZAMIC
_ _
PRODUCT INFORMATION
Edition 5.0 Jun 2022
PAGE
1 of 25
AUSTRALIAN PRODUCT INFORMATION
ZAMIC
(TRANEXAMIC ACID 500 MG/5 ML)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Tranexamic acid
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tranexamic acid 500 mg/5 mL
Each 5 mL ampoule of
Tranexamic Acid solution for injection contains 500 mg tranexamic
acid,
hydrochloric
acid
QS
for
pH
adjustment,
sodium
hydroxide
QS for
pH
adjustment
and
water for
injections QS to 5 mL as the inactive ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Solution for injection.
Tranexamic acid solution for injection is a sterile, clear, colourless
solution free from visible particles,
presented in glass ampoules. The pH is 6.5 to 7.5.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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
D
OSE AND METHOD OF ADMINISTRATION
TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL
ADMINISTRATION.
ZAMIC
_ _
PRODUCT INFORMATION
Edition 5.0 Jun 2022
PAGE
2 of 25
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 heartlung
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.
ADULT TOTAL HIP ARTHROPLASTY
Administration of 15 mg/kg tranexamic acid immediately prior to