TRANEXAMIC ACID LUMACINA tranexamic acid 1000 mg/10 mL solution for injection ampoule

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

tranexamic acid, Quantity: 1000 mg

Dostupné s:

Bridgewest Perth Pharma Pty Ltd

INN (Mezinárodní Name):

Tranexamic acid

Léková forma:

Injection, solution

Složení:

Excipient Ingredients: water for injections

Podání:

Intravenous

Jednotky v balení:

1 ampoule, 10 ampoules

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

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.

Přehled produktů:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Stav Autorizace:

Licence status A

Datum autorizace:

2010-09-16

Informace pro uživatele

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

Charakteristika produktu

Version: pfpcykli10822
Supersedes: pfpcyklt10622
Page 1 of 26
AUSTRALIAN
PRODUCT
INFORMATION
–
CYKLOKAPRON
®
(TRANEXAMIC
ACID)
SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Tranexamic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mL ampoule of Cyklokapron solution for injection contains 1000
mg tranexamic acid.
Cyklokapron Solution for Injection is a clear and colourless solution
contains 100 mg/mL
tranexamic acid.
3.
PHARMACEUTICAL FORM
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
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 DOSE AND METHOD OF ADMINISTRATION
TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL
ADMINISTRATION
INTRAVENOUS ADMINISTRATION
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 heart-lung machine.
Version: pfpcykli10822
Supersedes: pfpcyklt10622
Page 2 of 26
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 skin
incision, followed by a
repeat bolus 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 (also see Section 5.1
P