European Union - English - EMA (European Medicines Agency)

teva pharma b.v. - clopidogrel, acetylsalicylic acid - acute coronary syndrome; myocardial infarction - combinations - clopidogrel/acetylsalicylic acid teva is indicated for the prevention of atherothrombotic events in adult patients already taking both clopidogrel and acetylsalicylic acid (asa). clopidogrel/acetylsalicylic acid teva is a fixed‑dose combination medicinal product for continuation of therapy in:non‑st segment elevation acute coronary syndrome (unstable angina or non‑q‑wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary interventionst segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy

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

bayer healthcare pharmaceuticals inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g - finacea® (azelaic acid) gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. there are no adequate and well-controlled studies in pregnant women. therefore, finacea gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. e

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pfizer new zealand limited - tranexamic acid 100 mg/ml - solution for injection - 100 mg/ml - active: tranexamic acid 100 mg/ml excipient: nitrogen water for injection - haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. localfibrinolysis 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)

pfizer new zealand limited - tranexamic acid 100 mg/ml - solution for injection - 100 mg/ml - active: tranexamic acid 100 mg/ml excipient: nitrogen water for injection - haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. localfibrinolysis 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

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

luminarie pty ltd - tranexamic acid, quantity: 100 mg/ml - injection, solution - excipient ingredients: water for injections - 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)

atlantic biologicals corp. - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg in 5 ml - valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see for statement regarding fatal hepatic dysfunction. warnings valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction. valproic acid is contraindicated in patients with known hypersensitivity to the drug. valproic acid is contraindicated in patients with known urea cycl

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

rebel distributors corp - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings for statement regarding fatal hepatic dysfunction. valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction. valproic acid is contraindicated in patients with known hypersensitivity to the drug. valproic acid is contraindicated in patients with known urea cycle disorders (see warnings )

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

ncs healthcare of ky, inc dba vangard labs - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - valproic acid capsules, usp are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid capsules, usp are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures.    simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present.    see warnings for statement regarding fatal hepatic dysfunction. valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction.        valproic acid is contraindicated in patients with known hypersensitivity to the drug.        valproic acid is contraindicated in patien

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

caraco pharmaceutical laboratories, ltd. - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg in 5 ml - valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precautions (5.1) for statement regarding fatal hepatic dysfunction. valproic acid should not be administered to patients with hepatic disease or significant hepatic dysfunction [see warnings and precautions (5.1)] . valproic acid is contraindicated in patients with known hypersensitivity to the drug [see warnings and precautions (5.