Land: Armenië
Taal: Engels
Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
sulodexide
Alfasigma S.p.A.
B01AB11
sulodexide
300LSU/ml
solution for i/v and i/m injection
(10/2x5/) ampoules 2ml in blister
Prescription
Registered
2019-12-25
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 Excipients with known effects Each soft capsule contains: sodium ethyl para-hydroxybenzoate (E215): 0.26 mg per capsule sodium propyl para-hydroxybenzoate: 0.13 mg per capsule 3. PHARMACEUTICAL FORM Soft capsules: brick-red, oval capsules containing a white to grey suspension. Solution for intravenous and intramuscular injection: clear not more intensely coloured than brownish-yellow sterile solution. pH: 5.5 – 7.5. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Chronic venous ulcers. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION VESSEL DUE F 250 ULS SOFT CAPSULES: 1 capsule twice a day away from meals. VESSEL DUE F 600 ULS/2ML SOLUTION FOR INJECTION: 1 ampoule a day for intramuscular or intravenous administration. It is recommended to start the treatment with the ampoules and after 15-20 days continue with the capsules for 30-40 days. The complete treatment course should be repeated at least 2 times a year. The dosage may be changed in amount and frequency on the judgement of the physician. _Paediatric population _ The safety and effectiveness of sulodexide in children and adolescents under 18 years of age have not yet been established. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any one of the excipients listed in section 6.1, or to heparin or heparinoids. Haemorrhagic diathesis and haemorrhagic diseases. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Tracebility In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Due to the pharmaco-toxicological properties of sulodexide, the product does not require special precautions for use. However, during treatment with anticoagulants, the haemocoagulative parameters should be monitored periodically. VESSEL DUE F soft capsules 250 LSU_ _contains s Lees het volledige document