Nyuzilandi - Kiingereza - 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.

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Marekani - Kiingereza - 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

Nyuzilandi - Kiingereza - 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.

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

baxter holding b.v. - tranexamic acid ph. eur. - solution for injection/infusion - 100 milligram(s)/millilitre - tranexamic acid

Malta - Kiingereza - Medicines Authority

remedica limited limassol industrial estate, aharnon street, 3056 limassol, cyprus - tranexamic acid - film-coated tablet - tranexamic acid 500 mg - antihemorrhagics

Malta - Kiingereza - Medicines Authority

ibigen s.r.l via fossignano, 2, 04011 aprilia (lt), italy - tranexamic acid - solution for injection/infusion - tranexamic acid 100 mg/ml - antihemorrhagics

Malta - Kiingereza - Medicines Authority

ibigen s.r.l via fossignano, 2, 04011 aprilia (lt), italy - tranexamic acid - solution for injection/infusion - tranexamic acid 100 mg/ml - antihemorrhagics

Ayalandi - Kiingereza - HPRA (Health Products Regulatory Authority)

accord healthcare limited - tranexamic acid - solution for injection - 100 mg/ml - tranexamic acid