CYKLOKAPRON tranexamic acid 500mg/5mL solution for injection ampoule

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

tranexamic acid

Доступна з:

Pfizer Australia Pty Ltd

ІПН (Міжнародна Ім'я):

Tranexamic acid

Статус Авторизація:

Registered

Характеристики продукта

Version: pfpcyklt10420
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