Țară: Tanzania
Limbă: engleză
Sursă: Tanzania Medicinces & Medical Devices Authority
Tranexamic acid
Emcure Pharmaceuticals Limited, INDIA
Antifibrinolytics
Tranexamic acid
500 mg/ 5 ml
Injection
Emcure Pharmaceuticals Limited, INDIA
Physical description: A Clear colourless solution free from particulate matter; Local technical representative: Phillips Pharmaceuticals (Tanzania) Limited
Registered/Compliant
2020-12-24
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tranexamic Acid BP 500 mg in 5 ml for Injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml ampoule contains: Tranexamic Acid BP 500 mg Water for Injection BP q.s. 3. PHARMACEUTICAL FORM Clear colourless solution free from particulate matter 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tranexamic acid is indicated in adults and children from one year in prevention and treatment of haemorrhages due to general or local fibrinolysis. Specific indications include: - Haemorrhage caused by general or local fibrinolysis such as: • Menorrhagia and metrorrhagia, • Gastrointestinal bleeding, - Haemorrhagic urinary disorders, further to prostate surgery or surgical procedures affecting the urinary tract,Ear Nose Throat surgery (adenoidectomy, tonsillectomy, dental extractions), - Gynaecological surgery or disorders of obstetric origin, - Thoracic and abdominal surgery and other major surgical intervention such as cardiovascular surgery, - Management of haemorrhage due to the administration of a fibrinolytic agent. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ Unless otherwise prescribed, the following doses are recommended: 1. Standard treatment of local fibrinolysis: 0.5 g (1 ampoule of 5 mL) to 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) two to three times daily 2. Standard treatment of general fibrinolysis: 1 g (1 ampoule of 10 mL or 2 ampoules of 5 mL) tranexamic acid by slow intravenous injection or infusion (= 1 mL/minute) every 6 to 8 hours, equivalent to 15 mg/kg body weight (BW) _Renal impairment_ In renal insufficiency leading to a risk of accumulation, the use of tranexamic acid is contraindicated in patient with severe renal impairment (see section 4.3). For patients with mild to moderate renal impairment, the dosage of tranexamic acid should be reduced according to the serum creatinine level: Serum creatinine micromol/L mg/10 mL Dose Citiți documentul complet