CYKLOKAPRON tranexamic acid 2000 mg/20 mL solution for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tranexamic acid

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

Tranexamic acid

Authorization status:

Registered

Patient Information leaflet

CYKLOKAPRON
_Tranexamic acid Tablets and Solution for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
CYKLOKAPRON. It does not
contain all the information that is
known about CYKLOKAPRON.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you using
CYKLOKAPRON against the
benefits they expect it will have for
you.
Please read this leaflet carefully and
follow the instructions given to you
by your doctor and the advice
contained in this leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
USING 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 Tablets are 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)
CYKLOKAPRON Solution for
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.
HOW CYKLOKAPRON
WORKS
CYKLOKAPRON contains
tranexamic acid. Tranexamic acid is
an antifibrinolytic that works by
slowing the processes that cause
bleeding.
BEFORE TREATMENT WITH
CYKLOKAPRON
_WHEN CYKLOKAPRON MUST_
_NOT BE USED_
CYKLOKAPRON must not be used
if you:
•
have an allergy to tranexamic
acid or any of the ingredients
listed at the end of this leaflet.
•
are being treated for stroke
•
are being treated for blood clots
in your legs, lungs or anywhere
else in your body.
•
have a problem with colour vision
that developed after you were
born.
DO NOT USE CYKLOKAPRON AFTER
THE EXPIRY DATE (EXP) PRINTED ON
THE PACK.
Medicine taken after the expiry date
has passed may not work as well.
DO NOT USE CYKLOKAPRON IF
THE PACKAGING IS TORN

Summary of Product characteristics

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Supersedes: pfpcyklt10517
Page 1 of 28
AUSTRALIAN
PRODUCT
INFORMATION
–[
CYKLOKAPRON
® (TRANEXAMIC ACID)]
1.
NAME OF THE MEDICINE
Tranexamic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Cyklokapron tablet contains 500 mg of tranexamic acid.
Each 5 mL ampoule of Cyklokapron solution for injection contains 500
mg tranexamic acid.
Each 10 mL ampoule of Cyklokapron solution for injection contains 1000
mg tranexamic acid.
Each 20 mL vial of Cyklokapron solution for injection contains 2000 mg
tranexamic acid.
Cyklokapron Solution for Injection is a clear and colourless solution
contains 100 mg/mL
tranexamic acid.
3.
PHARMACEUTICAL FORM
Cyklokapron is available as film coated tablets and solution for
injection.
Cyklokapron solution for injection is a sterile, clear, colourless
solution. The pH is 6.5 to 8.0.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ORAL ADMINISTRATION
Hereditary angioneurotic oedema.
Short term use in the treatment of hyphaema and in patients with
established coagulopathies
who are undergoing minor surgery.
Menorrhagia.
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.
Version: pfpcyklt10420
Supersedes: pfpcyklt10517
Page 2 of 28
4.2 DOSE AND METHOD OF ADMINISTRATION
ORAL ADMINISTRATION
TRAUMATIC HYPHAEMA
1.0 to 1.5 g every 8 hours for six to seven days.
MENORRHAGIA
Two tablets (1 g) four times a day, increasing to three tablets (1.5
g) four times a day if needed,
for four days. Treatment should be initiated at the onset of visible
bleeding, and continued for
the first 4 days of the menstrual cycle. Patients should be assessed
after three months of
treatment.
No efficacy data are available from randomised, controlled clinical
trials for treatment beyo