国家: 约旦
语言: 英文
来源: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)
Heparin Sodium 5000 iu/ml
الشركة العربية للمستحضرات الطبية والزراعية - Arab Company for Medical & Agricultural Products
B01AB01
Heparin Sodium 5000 iu/ml
5000 iu/ml
50 Vial X 5ml
ليو فارما برودكتس (الدانمارك)
To be used together with CRT017 195 x 96,5 x 50 mm or CRT018 118 x 46 x 65 mm To be folded to 115 x 57 mm Creation Date: Revision Date: Sign: Sign: Scale: OMA 30/07/2012 Ref. No.: Size: Material: Type: 100% INS040-00 230 x 450 mm 45 g white Insert, 2 + 4 columns PACKAGING COMPONENT SPECIFICATION LEO Pharma Internal Market Access Industriparken 55 2750 Ballerup Denmark Heparin 10 x 10 ml and 50 x 5 ml Denmark Scale Get-up Matrial No Sent by e-mail Subject Date Colour Sign. Date Sign. Preparation Place of production Strength Packsize Comments: ▲ 100% E+S+A 056845 EBD OMA Black Heparin LEO Page 1 of 2 Pointsize: 6 pt 09/10/17 16/10/17 INS 230 x 450 mm HEPARIN LEO 1. NAME OF THE MEDICINAL PRODUCT Heparin Heparin sodium Carefully read this insert before administering this product. It contains information about your treatment. If you have any doubt or you are not sure about something, please ask your physician or Pharmacist. Keep this insert as you might need to read it again. Verify this product fully corresponds to the one prescribed by your physician. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Heparin sodium 1,000 IU/ml Pack sizes: 5 ml x 5 and 5 ml x 50. Excipients, which the clinician should be aware of: Benzyl alcohol, methyl- and propylparahydroxybenzoate Heparin sodium 5,000 IU/ml Pack sizes: 5 ml x 5 and 5 ml x 50. Excipients, which the clinician should be aware of: Benzyl alcohol, methyl- and propylparahydroxybenzoate All excipients are listed under section 6.1 Not all pack sizes and strengths may be marketed Sale under prescription 3. PHARMACEUTICAL FORM Solution for injection Vials with clear, colourless or yellow liquid, free of turbidity and visible particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Heparin is indicated for prophylaxis and treatment of venous thrombosis and pulmonary embolism; in the treatment of myocardial infarction and arterial embolism; for prevention of clotting in arterial and heart surgery and for prevention of cerebral thrombosis. Heparin may also be used as an anti 阅读完整的文件