Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
tranexamic acid
Pfizer Australia Pty Ltd
Medicine Registered
Registered
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 Прочетете целия документ