United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals (usa) inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 100 mg in 1 ml - tranexamic acid injection is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated: - in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. - in patients with active intravascular clotting [see warnings and precautions (5.1)] . - in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions (5.4)] . risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormalities that result

United States - English - NLM (National Library of Medicine)

american regent, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 100 mg in 1 ml - tranexamic acid injection, usp is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection is contraindicated: - in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. - in patients with active intravascular clotting [see warnings and precautions (5.1)] . - in patients with hypersensitivity to tranexamic acid or any of the ingredients [ see warnings and precautions (5.4)] . risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormalities that re

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals labs inc. d/b/a avet pharmaceuticals labs inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 1 g in 10 ml - tranexamic acid injection, usp is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. tranexamic acid injection, usp is contraindicated: -   in patients with subarachnoid hemorrhage. anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid injection in such patients. -   in patients with active intravascular clotting [see warnings and precautions ( 5.1)] . -   in patients with hypersensitivity to tranexamic acid or any of the ingredients [see warnings and precautions ( 5.4 )]. risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are 2 (0.02%) infant cases with structural abnormal

Australia - English - Department of Health (Therapeutic Goods Administration)

medsurge pharma pty ltd - tranexamic acid, quantity: 500 mg - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - 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.

New Zealand - English - Medsafe (Medicines Safety Authority)

medsurge pharma limited - tranexamic acid 100 mg/ml;   - solution for injection - 500 mg/5ml - active: tranexamic acid 100 mg/ml   excipient: hydrochloric acid sodium hydroxide water for injection - 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 precautions). - gastrointestinal haemorrhage.

New Zealand - English - Medsafe (Medicines Safety Authority)

boucher & muir (nz) ltd t/a mercury pharma (nz) - tranexamic acid 500mg - film coated tablet - 500 mg - active: tranexamic acid 500mg excipient: basic butylated methacrylate copolymer colloidal silicon dioxide croscarmellose sodium isopropyl alcohol macrogol 8000 magnesium stearate   microcrystalline cellulose povidone purified talc   purified water titanium dioxide vanillin - 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) -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 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - tranexamic acid, quantity: 100 mg/ml - injection - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

aft pharmaceuticals pty ltd - tranexamic acid, quantity: 100 mg/ml - injection - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - 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.

United States - English - NLM (National Library of Medicine)

exela pharma sciences, llc - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid in sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce the risk of hemorrhage during and following tooth extraction. tranexamic acid in sodium chloride injection is contraindicated: risk summary available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not identified a drug-associated risk of miscarriage or adverse maternal or fetal outcomes. there are no reports regarding the use of tranexamic acid during the first trimester of pregnancy; therefore, there are no data regarding the risk of major birth defects with use of tranexamic acid during pregnancy. however, tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see data). reproduction studies performed in mice, rats, and rabbits have not revealed any adverse effects on the fet

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - tranexamic acid (unii: 6t84r30kc1) (tranexamic acid - unii:6t84r30kc1) - tranexamic acid 650