资料单张
CYKLOKAPRON
_Tranexamic acid tablets and solution for injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
CYKLOKAPRON. This leaflet
answers some common questions
about CYKLOKAPRON.
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
CYKLOKAPRON against the
expected benefits it will have for
you.
Use CYKLOKAPRON 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 CYKLOKAPRON
IS USED FOR
CYKLOKAPRON is used to prevent
excessive bleeding in patients with:
•
traumatic hyphaema (bleeding
into the front part of the eye)
•
blood clotting disorders, who are
having minor surgery
•
heavy periods
•
hereditary angioneurotic oedema
(periodic swelling of the throat)
It may also be 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 CYKLOKAPRON
WORKS
CYKLOKAPRON contains
tranexamic acid. Tranexamic acid is
an antifibrinolytic that works by
slowing the processes that cause
bleeding.
BEFORE TAKING
CYKLOKAPRON
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYKLOKAPRON IF
YOU HAVE AN ALLERGY TO
CYKLOKAPRON OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE CYKLOKAPRON IF
YOU ARE BEING TREATED FOR A STROKE.
DO NOT TAKE CYKLOKAPRON IF
YOU ARE BEING TREATED FOR BLOOD
CLOTS IN YOUR LEGS, LUNGS OR
ANYWHERE ELSE IN YOUR BODY.
DO NOT TAKE CYKLOKAPRON IF
YOU HAVE A PROBLEM WITH COLOUR
VISION THAT DEVELOPED AFTER YOU
WERE BORN.
DO NOT TAKE CYKLOKAPRON
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 CYKLOKAPRON IF
TH
阅读完整的文件
产品特点
Version: pfpcyklt10313
Supercedes: pfpcyklt10112
Page 1 of 27
PRODUCT INFORMATION
CYKLOKAPRON
®
TRANEXAMIC ACID
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 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.
The pKa: 4.3 and 10.6.
Each CYKLOKAPRON tablet contains 500 mg of tranexamic acid as well as the following
inactive ingredients: cellulose-microcrystalline, talc-purified, magnesium stearate, colloidal
anhydrous silica, povidone, hydroxypropylcellulose, titanium dioxide, macrogol 8000,
vanillin and the proprietary ingredient, Eudragit E100
(ID Number 1753).
CYKLOKAPRON solution for injection is a sterile, clear, colourless solution. The pH is
6.5 to 8.0.
Each 5 mL ampoule of CYKLOKAPRON solution for injection contains 500 mg tranexamic
acid and 5 mL Water for Injections as the inactive ingredient.
Each 10 mL ampoule of CYKLOKAPRON solution for injection contains 1000 mg
tranexamic acid and 10 mL Water for Injections as the
inactive ingredient.
Version: pfpcyklt10313
Supercedes: pfpcyklt10112
Page 2 of 27
PHARMACOLOGY
PHARMACODYNAMICS
Tranexamic acid is a competitive inhibitor of plasminogen activation and at much higher
concentrations a noncompetitive inhibitor of plasmin, thus implying that
阅读完整的文件