Ország: Szingapúr
Nyelv: angol
Forrás: HSA (Health Sciences Authority)
TRANEXAMIC ACID
PFIZER PRIVATE LIMITED
B02AA02
500 mg
TABLET, FILM COATED
TRANEXAMIC ACID 500 mg
ORAL
Prescription Only
Pfizer Italia S.r.l.
ACTIVE
1989-03-09
CYK-SIN-0213/0 Date of Last Revision: February 2013 Page 1 of 8 1. NAME OF THE MEDICINAL PRODUCT CYKLOKAPRON TABLETS CYKLOKAPRON INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: tranexamic acid 3. PHARMACEUTICAL FORM Film-coated tablets Injection Chemical Name: trans-4-(aminomethyl) cyclohexanecarboxylic acid. Structural Formula: Empirical Formula: C 8 H 15 NO 2 Molecular Weight: 157.2 Tranexamic acid is a white crystalline powder. 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: menorrhagia, prostatectomy and bladder surgery, haematuria, gastro-intestinal haemorrhage, epistaxis, ulcerative colitis, conisation of the cervix, and dental extraction in patients with coagulopathies. General fibrinolysis may occur in the following conditions and situations: Dosage Form Strength Film-Coated Tablets 500 mg Injection 100 mg/mL CYK-SIN-0213/0 Date of Last Revision: February 2013 Page 2 of 8 Prostatic and pancreatic cancer, after thoracic and other major surgery, in obstetrical complications such as ablatio placentae and post partum haemorrhage, leukemia, liver diseases, in connection with thrombolytic therapy with streptokinase. • Hereditary angioneurotic oedema 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The recommended standard dose is 5 to 10 mL by slow intravenous injection at a rate of 1 ml/minute or 2 to 3 tablets of 0.5 g two to three times daily. For the indications listed below the following doses are recommended: General fibrinolysis: 1.0 g (2 ampoules of 5 mL) by slow intravenous injection every six to eight hours. Prostatectomy: 0.5 to 1.0 g orally (1 to 2 ampoules of 5 mL) by slow intravenous Olvassa el a teljes dokumentumot
1. NAME OF THE MEDICINAL PRODUCT CYKLOKAPRON TABLETS CYKLOKAPRON INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: tranexamic acid 3. PHARMACEUTICAL FORM Film-coated tablets Injection Chemical name: trans-4-(aminomethyl) cyclohexanecarboxylic acid. Structural formula: Empirical formula: C 8 H 15 NO 2 Molecular weight: 157.2 Tranexamic acid is a white crystalline powder. 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: Menorrhagia, prostatectomy and bladder surgery, haematuria, gastrointestinal haemorrhage, epistaxis, ulcerative colitis, conisation of the cervix, and dental extraction in patients with coagulopathies. General fibrinolysis may occur in the following conditions and situations: Prostatic and pancreatic cancer, after thoracic and other major surgery, in obstetrical complications such as ablatio placentae and postpartum haemorrhage, leukemia, liver diseases, in connection with thrombolytic therapy with streptokinase. • Hereditary angioneurotic oedema. DOSAGE FORM STRENGTH Film-coated tablets 500 mg Injection 100 mg/mL 4.2. POSOLOGY AND METHOD OF ADMINISTRATION TRANEXAMIC ACID MUST NOT BE USED FOR INTRATHECAL OR EPIDURAL ADMINISTRATION. The recommended standard dose is 5 mL to 10 mL by slow intravenous injection at a rate of 1 mL/minute or 2 to 3 tablets of 0.5 g 2 to 3 times daily. For the indications listed below, the following doses are recommended: _General fibrinolysis_ : 1.0 g (2 ampoules of 5 mL) by slow intravenous injection every 6 to 8 hours. _Prostatectomy_ : 0.5 g to 1.0 g (1 to 2 ampoules of 5 mL) by slow intravenous injection every 6 to 8 hours (the first injection being given during the operation) for the first 3 days after surgery, thereafter 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily until macroscopic haematuria is no longer present. _Haematuria_ : 1 g to 1.5 g orally (2 to 3 tablets) 2 to 3 times daily u Olvassa el a teljes dokumentumot