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Arwin

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Indications:

For the treatment of established deep vein thrombosis; central retinal and branch vein thrombosis; priapism; pulmonary hypertension of embolic origin; embolism after insertion of prosthetic cardiac valves; rethrombosis after thrombolytic therapy and rethrombosis after vascular surgery. It is also indicated for the prevention of deep venous thrombosis after repair of the fractured neck of a femur. For the treatment of moderate and severe chronic circulatory disorders of peripheral arteries (eg. arteriosclerosis obliterans, thromboangiitis obliterans, diabetic microangiopathy and Raynaud’s phenomenon). Ancrod has been shown to be useful for maintaining anticoagulation in the presence of Heparin-induced thrombocytopaenia (HIT) and thrombosis. Physicians should have at any time access to fibrinogen enriched cryoprecipitate. Study Results in Patients with early ischaemic Stroke.

Contraindications:

•Known bleeding disorders of any origin or any unexplained excessive bleedings in the past. •Platelet counts of less than 100,000 (even if asymptomatic), exemption : HIT (Heparin- induced thrombocytopaenia). •Planned surgery or short before delivery. •Active ulcerations of the GIT. •Any kind of malignant disease. •Renal stones (increased likelihood of significant urological bleeding). •Severe and uncontrolled arterial hypertension. •Active pulmonary tuberculosis. •Impaired fibrinolysis. •Severe liver disease. •Manifest or impending shock. •I.M.-Injection : Ancrod should not be injected i.m., because of rapid induction of neutralizing antibodies and therefore drug resistance.

Adverse reactions:

•Hypersensitivity reactions : Local or generalized skin reactions (rash and urticaria); appearance of neutralizing antibodies to ancrod with partial or total loss of ancrod activity (drug resistance). •Sometimes pain at injection site (normally mild). This side-effect may be, if necessary, treated with local or oral antihistaminic drugs (eg. clemastine, or diphenhydramine). Bleeding at injection site, thrombophlebitis at local veins, and (paradoxical) arterial thrombotic events. •Occasionally deposition of cleaved fibrinogen derivates in the splen resulting in splenomegaly; rupture is possible, if the spleen is palpated too strongly (life-threatening bleeding and need of splenectomy may result). •Specific side-effects are local and systemic bleeding events. Local bleeding events may be treated with local pressure or surgical dressings, if necessary. Compared with other anticoagulants the risk of systemic bleeding is relatively low. If systemic bleeding is severe enough to warrant fast reversal of ancrod action, fibrinogen should be substituted (please refer to section ’special antidotes’). •Occasionally, increased headache has beend found in patients with known migraine. •Also, chills and fever may occur infrequently. Thrombocytopaenia as side-effect has never been noticed with ancrod in contrast to heparin.

Interactions:

The risk of bleeding events is increased, if other anticoagulants (eg. coumarines such as warfarin), inhibitors of thrombocytic aggregation such as aspirin, or fibrinolytics such as urokinase are used concomitantly or within a period of 10 days after discontinuation of ancrod. Plasma expanders: Artificial plasma expanders (eg. dextran) may cause severe bleeding in defibrinated patients and should not be administered during or within 10 days of ancrod therapy. Severe GIT-bleedings may result from the concomitant use of NSAIDs, glucocorticosteroids, nicotinic acid derivates, or other drugs with ulcerogenic potential. The danger of thromboembolic events is considerably increased, if ancrod is given immediately after systemic fibrinolytics.

Warnings:

•Known bleeding disorders of any origin or any unexplained excessive bleedings in the past. •Platelet counts of less than 100,000 (even if asymptomatic), exemption : HIT (Heparin- induced thrombocytopaenia). •Planned surgery or short before delivery. •Active ulcerations of the GIT. •Any kind of malignant disease. •Renal stones (increased likelihood of significant urological bleeding). •Severe and uncontrolled arterial hypertension. •Active pulmonary tuberculosis. •Impaired fibrinolysis. •Severe liver disease. •Manifest or impending shock. •I.M.-Injection : Ancrod should not be injected i.m., because of rapid induction of neutralizing antibodies and therefore drug resistance. Pregnancy Category X : Ancrod was not found to be teratogenic in animal studies, but some foetal deaths occurred as a result of placental haemorrhages in animals given high doses; therefore, it should not be used during pregnancy as the defibrinogenation mechanism of ancrod might be expected to interfere with the normal implantation of the fertilized egg.

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