Hospira Tranexamic Acid Injection tranexamic acid 500 mg in 5 mL 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
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
Tranexamic acid
Authorization status:
Registered
Patient Information leaflet
HOSPIRA™ TRANEXAMIC ACID
INJECTION
Tranexamic Acid
CONSUMER MEDICINE INFORMATION_ _
_Date of Dispensing _
_Consumer Name _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about HOSPIRA™
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 receiving
HOSPIRA™ Tranexamic Acid
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
HAVING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
WHAT HOSPIRA™
TRANEXAMIC ACID
INJECTION IS USED FOR
HOSPIRA™ Tranexamic Acid
Injection is used to reduce bleeding
and the need for blood transfusion
in adults and children undergoing
heart surgery, and adults
undergoing total knee or hip
replacement surgery.
It works by slowing the breakdown
of blood clots.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU ARE GIVEN
HOSPIRA™
TRANEXAMIC ACID
INJECTION
_WHEN YOU MUST NOT BE GIVEN _
_IT _
YOU MUST NOT BE GIVEN
HOSPIRA™ TRANEXAMIC ACID
INJECTION IF YOU
•
have an allergy to tranexamic
acid
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
YOU MUST NOT BE GIVEN IT IF
•
you have a problem with colour
vision that developed after you
were born
•
you have problems associated
with blood clots or stroke.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
•
kidney problems
•
convulsions, fits or seizures.
•
you, or someone in your family
has ever suffered from stroke or
blood clots
TELL YOUR
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Summary of Product characteristics
HOSPIRA™ TRANEXAMIC ACID INJECTION
NAME OF THE MEDICINE
Tranexamic acid
The chemical structure of tranexamic acid is:
Chemical name: trans-4-(aminomethyl) cyclohexane-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 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.
Hospira™ Tranexamic Acid Injection is a sterile, clear, colourless
solution. The pH is 6.5 to
8.0.
Each 5 mL ampoule of Hospira™ Tranexamic Acid Injection contains 500
mg tranexamic
acid, made up to 5 mL with Water for Injections (as the inactive
ingredient).
Each 10 mL ampoule of Hospira™ Tranexamic Acid Injection contains
1000 mg tranexamic
acid, made up to 10 mL with Water for Injections (as the inactive
ingredient).
PHARMACOLOGY
PHARMACODYNAMICS
Tranexamic acid is a competitive inhibitor of plasminogen activation
and at much higher
concentrations a noncompetitive 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.
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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 tranexamic acid in concentrations
of 1 mg/mL and 10
mg/mL blood prolongs the thrombin time.
Clinical pharmacodynamics data that examined the
_in vivo_
effect o
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