TRANEXAMIC ACID INJECTION MEDSURGE tranexamic acid 500 mg/5 mL solution for injection ampoule

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

tranexamic acid, Quantity: 500 mg

Beschikbaar vanaf:

Medsurge Pharma Pty Ltd

farmaceutische vorm:

Injection, intravenous infusion

Samenstelling:

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

Toedieningsweg:

Intravenous

Eenheden in pakket:

5 packs of 5mL ampoules

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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 samenvatting:

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

Autorisatie-status:

Registered

Autorisatie datum:

2017-12-20

Bijsluiter

_TRANEXAMIC ACID INJECTION MEDSURGE_ CMI ANZ V3.0 (JANUARY 2018)
1
_TRANEXAMIC ACID INJECTION _
_ _
_TRANEXAMIC ACID _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before
you
start
taking
Tranexamic
Acid
Injection.
This
leaflet
answers
some
common questions about Tranexamic
Acid Injection.
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 Tranexamic Acid Injection
against
the
expected
benefits
it
will
have for you.
Use
Tranexamic
Acid
Injection
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 TRANEXAMIC ACID
INJECTION IS USED FOR
Tranexamic Acid 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.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
HOW TRANEXAMIC ACID
INJECTION WORKS
Tranexamic
Acid
Injection
contains
tranexamic acid. Tranexamic acid is an
antifibrinolytic that works by slowing
the processes that cause bleeding.
BEFORE TAKING
TRANEXAMIC ACID
INJECTION
_WHEN YOU MUST NOT TAKE IT _
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU HAVE AN ALLERGY TO
TRANEXAMIC ACID INJECTION OR ANY OF
THE INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU ARE BEING TREATED FOR
A STROKE.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU ARE BEING TREATED FOR
BLOOD
CLOTS
IN
YOUR
LEGS,
LUNGS
OR
ANYWHERE ELSE IN YOUR BODY.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION IF YOU HAVE A PROBLEM WITH
COLOUR VISION THAT DEVELOPED AFTER YOU
WERE BORN.
DO
NOT
TAKE
TRANEXAMIC
ACID
INJECTION AFTER THE EXPIRY DATE (EXP)
PRINTED ON THE PACK.
If you take this medicine after

Productkenmerken

TRANEXAMIC ACID INJECTION
PRODUCT INFORMATION
Edition 1.0 – January 2018
Page 1 of 24
PRODUCT INFORMATION
_TRANEXAMIC ACID INJECTION _
TRANEXAMIC ACID 500MG/5ML INJECTION AMPOULE
NAME OF THE MEDICINE
Tranexamic acid
The chemical structure of tranexamic acid is:
Chemical name: _trans_-4-aminomethylcyclohexane-carboxylic acid.
The molecular formula of tranexamic acid is C
8
H
15
NO
2
and its molecular weight is 157.2.
The
CAS number for tranexamic acid is 1197-18-8.
DESCRIPTION
Tranexamic acid is a white crystalline powder freely soluble in water
and in glacial acetic acid,
practically insoluble in methanol, ethanol, acetone, diethyl ether and
benzene.
The pKa: 4.3 and 10.6.
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.
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.
PHARMACOLOGY
PHARMACODYNAMICS
Tranexamic acid is a competitive inhibitor of plasminogen activation
and at much higher
concentrations a non-competitive inhibitor of plasmin, thus implying
that tranexamic acid
interferes with the fibrinolytic process in the same way as
aminocaproic acid. Tranexamic acid
is about 10 times more potent _in vitro _than aminocaproic acid.
Tranexamic acid binds more strongly than aminocaproic acid to both the
strong and weak
sites of the plasminogen molecule in a ratio corresponding to the
difference in potency
between the compounds.
TRANEXAMIC ACID INJECTION
PRODUCT INFORMATION
Edition 1.0 – January 2018
Page 2 of 24
Tranexamic acid in a concentration of 1 mg/mL does not aggregate
platelets _ in vitro. _
Tranexamic acid in concentrations up to 10 mg/mL blood has no
influence on the platelet
count, the coagulation time or various coagulation factors in whole
blood or citrated blood in
normal subjects. On the other hand tranexam