Hibor 2500/3500/5000/7500/10000 IU

Bemiparin Na

2,500 IU anti-Xa/ 0.2 mL or 3,500 IU anti-Xa/0.2 mL: Prevention of thromboembolic disease in patients undergoing general & orthopedic surgery & in non-surgical patients w/ high or mild risk. Secondary prevention of venous thromboembolism recurrences in patients w/ DVT & transitory risk factors. Prevention of clotting in the extracorporeal circulation circuit during haemodialysis. 5,000 IU anti-Xa/0.2 mL or 7,500 IU anti-Xa/0.3 mL or 10,000 IU anti-Xa/0.4 mL: Established DVT w/ or w/o pulmonary embolism.

SC Adult General surgery w/ moderate risk of venous thromboembolism On the day of the surgical procedure: 2,500 IU anti-Xa 2 hr before, or 6 hr post-op. On subsequent days: 2,500 IU anti-Xa every 24 hr. Orthopedic surgery w/ high risk of venous thromboembolism On the day of the surgical procedure: 3,500 IU anti-Xa 2 hr before, or 6 hr post-op. On subsequent days: 3,500 IU anti-Xa every 24 hr. Follow & maintain prophylactic treatment for at least 7-10 days post-op & until risk of thromboembolic disease has decreased. Prevention of thromboembolic disease in non-surgical patients 2,500 or 3,500 IU/day. Secondary prevention of the venous thromboembolism recurrences in patients w/ DVT & transitory risk factors 3,500 IU/day up to a max of 3 mth. Prevention of clotting in the extracorporeal circulation circuit during haemodialysis Patients undergoing repeated haemodialysis sessions of no >4 hr & w/ no risk of bleeding weighing >60 kg 3,500 IU bolus as a single dose into the arterial line at the beginning of the dialysis session, <60 kg 2,500 IU bolus as a single dose into the arterial line at the beginning of the dialysis session. DVT 115 IU anti-Xa/kg/day during 7±2 days. Patients weighing >120 kg 115 IU anti-Xa/kg/day, 100-120 kg 12,500 IU anti-Xa, 70-100 kg 10,000 IU anti-Xa, 50-70 kg 7,500 IU anti-Xa, <50 kg 5,000 IU anti-Xa. Unless contraindicated, initiate oral anticoagulant treatment between days 3-5 after starting administration. Hibor may be discontinued once reached the mentioned value of INR. Oral anticoagulation should be continued during a min of 3 mth. Patients w/ DVT & transitory risk factors 3,500 IU/day up to a max of 3 mth.

Hypersensitivity to bemiparin Na, heparin or substances of porcine origin. History of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia. Active haemorrhage or increased risk of bleeding due to impairment of haemostasis. Severe impairment of liver or pancreatic function. Injuries to or operations on the CNS, eyes & ears w/in the last 2 mth. Disseminated intravascular coagulation attributable to heparin-induced thrombocytopenia. Acute bacterial endocarditis & slow endocarditis. Organic lesions susceptible of bleed eg, active peptic ulcer, haemorrhagic stroke, cerebral aneurysm or cerebral neoplasms.

Do not administer by IM. Hepatic or renal failure, uncontrolled arterial HTN, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis &/or urethrolithiasis, choroid & retinal vascular disease or any other organic lesion susceptible of bleed or patients undergoing spinal or epidural anaesth &/or lumbar puncture. Risk of hyperkalaemia in patients w/ DM, chronic renal failure, pre-existing metabolic acidosis, raised plasma K or those taking K-sparing drugs. Measure serum electrolytes in patients at risk before therapy & monitor regularly thereafter, particularly if treatment is prolonged >7 days. Patients w/ a history of heparin-induced thrombocytopenia. Measure platelet counts before administration on the 1st day of therapy & then regularly 3-4 days & at the end of therapy. Discontinue treatment immediately & initiate alternative therapy if significantly reduced platelet count (30-50%) is observed; cutaneous necrosis occurs. Increased risk of epidural or spinal haematoma in concomitant administration of NSAIDs, platelet inhibitors or anticoagulants & by, traumatic or repeated puncture in patients undergoing epidural or spinal anesth or lumbar puncture. Extreme vigilance & frequent monitoring of signs & symptoms of neurological impairment (eg, back pain, sensory & motor deficits), bowel or bladder dysfunction if therapy is to be administered in epidural or spinal anaesth. Initiate urgent diagnosis & treatment if signs or symptoms of epidural or spinal haematoma occurs. Pregnancy & lactation. Childn <18 yr.

Ecchymosis, haematoma & pain at inj site. Bleeding complications (skin, mucous membranes, wounds, GI & urogenital tract); mild & transient elevations of transaminases (AST, ALT) & γ-GT levels.

Increase pharmacological effect & risk of bleeding w/ vit K antagonists & other anticoagulants, ASA & other salicylates & NSAIDs, ticlopidine, clopidogrel & other platelet inhibitors systemic glucocorticoids & dextran. Drugs that increase serum K conc. Decreased efficacy w/ IV nitroglycerine.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AB12 - bemiparin ; Belongs to the class of heparin group. Used in the treatment of thrombosis.

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