Enoxaparin has been evaluated at 4102 after more than 15,000 patients were
treated with enoxaparin in 2113 trials. Included in the prevention of deep vein
thrombosis in 1776 patients at risk of 1653 plugs for orthopedic or abdominal
surgery; Prophylaxis of deep vein thrombosis in 1,169 patients with acute
medical disease who had severe activity restriction; 559 patients with deep vein
thrombosis with pulmonary embolism and 1579 patients with unstable angina
pectoris (ANGina pectoris) and non-Q Logon (MI) were treated. 10,176 patients
were treated for acute CT segment elevation myocardial infarction.
During these clinical trials, enoxaparin sodium usage and dosage varied according to the indications. The dose of enoxaparin sodium for prophylaxis of deep vein thrombosis (DVT) is 40mg once daily subcutaneously in patients with acute medical conditions after surgery or with severe activity restriction. In the treatment of deep vein thrombosis (DVT) with or without pulmonary embolism (PE), patients received enoxaparin subcutaneous injection of 1mg/kg every 12 hours or 1.5mg/kg subcutaneous injection of enoxaparin daily. In clinical studies for unstable angina pectoris and non-Q-wave myocardial infarction, enoxaparin sodium was administered subcutaneously once every 12 hours, and in clinical studies for acute ST-segment elevation myocardial infarction, enoxaparin sodium was administered intravenously at a regimen of 30mg rapidly followed by subcutaneously at 1mg/kg every 12 hours.
Adverse reactions observed in these clinical studies and empirically reported after marketing are as follows: such as hematoma, ecchymosis outside injection site, wound hematoma, hematuria, nosebleed, and gastrointestinal bleeding.
In addition, post-marketing experience: thromboembolic complications are considered severe in surgical patients; (1) if the bleeding results in a significant clinical event, or (2) if there is a co-occurrence of haemoglobin decline or infusion of 2 or more units of blood products. Retroperitoneal hemorrhage and intracranial hemorrhage have long been considered as the most serious bleeding. Thrombocytopenia and thrombocytopenia.
Additional marketing experience: Rare: Immunoallergic thrombocytopenia with thromboembolism: in some cases, thromboembolism is associated with organ infarction or limb ischemia (see [Cautions] : monitoring of platelet count). Other clinically relevant adverse reactions are classified according to the descending order of systemic organ types, incidence and severity. The following table includes adverse reactions of all indications: in addition, abnormal and rare skin and subcutaneous tissues of marketing experience; Skin vasculitis and skin necrosis are usually present at the injection site (these phenomena are usually preceded by purpura or erythema, infiltration, and pain). Enoxaparin sodium therapy must be discontinued. Injection site nodules (inflammatory nodules, non-enoxaparin wrapped line). It resolves after a few days and should not cause treatment to stop.