Krajina: Arménsko
Jazyk: angličtina
Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sulodexide
Alfa Wassermann S.p.A.
sulodexide
300LSU/ml
solution for i/m and i/v injection
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT VESSEL DUE F® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Soft capsules: Sulodexide 250 LSU Ampoules: Sulodexide 600 LSU 3. PHARMACEUTICAL FORM Soft capsules Injectable solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Angiopathy with high risk of thrombosis including thrombosis after acute myocardial infarction; Stroke (acute ischemic stroke and at early rehabilitation phase after stroke); discirculatory encephalopathy caused by atherosclerosis, diabetes mellitus, arterial hypertension; vascular dementia Peripheral arterial obstructive disease (of atherosclerotic and diabetic origin) Venous disease and deep vein thrombosis Microangiopathy (nephropathy, retinopathy, neuropathy) and macroangiopathy in diabetes mellitus (diabetic foot, encephalopathy, cardiopathy) Thrombophilia, antiphospholipid syndrome (sulodexide is administered in combination with acetylsalicylic acid after the treatment with low molecular weight heparin) Heparin-induced thrombotic thrombocytopenia (as sulodexide does not induce and aggravate it). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Solution for intravenous and intramuscular injections. Capsules . Treatment begins with daily intramuscular injection of 1 ampoule of a preparation or intravenous bolus or drop infusion preliminary having dissolved in 150 – 200 ml physiological solution. The course treatment is 15-20 days. Then, within 30-40 days, therapy should be continued with 1 capsule 2 times a day orally between food intake. . The treatment complete course should be repeated at least 2 times a year. Depending on results of clinical and laboratory investigations the treatment regime can be changed upon physician’s decision. 4.3 CONTRA-INDICATIONS - Hypersensitivity; - Hemorrhagic diathesis and the diseases accompanied by lowered coagulability of blood; - Pregnancy in I trimester. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE During sulodexide administration the haemocoagulative parameters should be Prečítajte si celý dokument