Cyklokapron

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Tranexamic acid 100 mg/mL

Disponible des:

Pfizer New Zealand Limited

Designació comuna internacional (DCI):

Tranexamic acid 100 mg/mL

Dosis:

100 mg/mL

formulario farmacéutico:

Solution for injection

Composición:

Active: Tranexamic acid 100 mg/mL Excipient: Water for injection

Unidades en paquete:

Ampoule, 5mL, 10 dose units

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Kyowa Pharma Chemical Co. Ltd.

indicaciones terapéuticas:

Haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis may occur in the following conditions: · Prostatectomy and bladder surgery · Menorrhagia · Epistaxis · Conisation of the cervix · Management of dental extraction in patients with coagulopathies · Ulcerative colitis · Haematuria · Gastrointestinal haemorrhage. General fibrinolysis as in prostatic and pancreatic cancer; after thoracic and other major surgery: · in obstetrical complications such as abruptio placentae and post-partum haemorrhage · in leukaemia and liver diseases and in connection with thrombolytic therapy with streptokinase.

Resumen del producto:

Package - Contents - Shelf Life: Ampoule, 5mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 10mL - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light

Data d'autorització:

1988-07-14

Informació per a l'usuari

CYKLOKAPRON
1
CYKLOKAPRON
_Tranexamic acid Tablets and Solution for Injection_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CYKLOKAPRON.
It does not contain all the available
information and 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 being treated with
CYKLOKAPRON against the
benefits it is expected to 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
BEING TREATED WITH THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
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 OR SHOWS
SIGNS OF TAMP

Fitxa tècnica

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Page 1 of 20
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
CYKLOKAPRON
®
500 mg tablets.
CYKLOKAPRON
®
100 mg/mL solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 500 mg tablet contains 500 mg tranexamic acid.
Each 5 mL ampoule contains 500 mg of tranexamic acid and 5 mL water
for injections.
Each 10 mL ampoule contains 1000 mg tranexamic acid and 10 mL water
for injections.
For the full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
CYKLOKAPRON 500 mg tablets are white, capsule shaped, film coated,
engraved CY within
arcs, dimensions 8.0 mm x 18.0 mm.
CYKLOKAPRON Solution for injection is a sterile, clear and colourless
solution, containing
100 mg/mL tranexamic acid.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Haemorrhage or risk of haemorrhage in increased fibrinolysis or
fibrinogenolysis. Local
fibrinolysis may occur in the following conditions:
•
Prostatectomy and bladder surgery
•
Menorrhagia
•
Epistaxis
•
Conisation of the cervix
•
Management of dental extraction in patients with coagulopathies
•
Ulcerative colitis
•
Haematuria (Tranexamic acid therapy is not indicated in haematuria
caused by diseases
of the renal parenchyma (also see Section 4.4)).
•
Gastrointestinal haemorrhage.
General fibrinolysis as in prostatic and pancreatic cancer; after
thoracic and other major
surgery:
•
in obstetrical complications such as abruptio placentae and
post-partum haemorrhage
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Supersedes: pfdcykla10817
Page 2 of 20
•
in leukaemia and liver diseases and in connection with thrombolytic
therapy with
streptokinase.
Hereditary angioneurotic oedema.
For the reduction of peri– and post-operative blood loss and the
need for blood transfusion in
adult patients undergoing cardiac surgery or total knee arthroplasty
or total hip arthroplasty.
For the reduction of peri- and post-operative blood loss and the need
for blood transfusion in
paediatric patients undergoing cardiac surgery.
4.2 DOSE AND METH