Land: Ísrael
Tungumál: enska
Heimild: Ministry of Health
UROKINASE
TZAMAL BIO-PHARMA LTD
B01AD04
POWDER FOR SOLUTION FOR INJECTION
UROKINASE 500000 IU
LOCAL INSTILLATION, INTRA-ARTERIAL, I.V
Required
MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE MBH, GERMANY
UROKINASE
UROKINASE
Peripheral arterial thrombosis ;Acute and subacute deep vein thrombosis ; Acute diagnostically confirmed pulmonary embolism, in particular when associated with unstable haemodynamic status ; Thrombosed arteriovenous shunt.
2015-06-30
The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in July 2010. UROKINASE MEDAC 10,000 I.U, 50,000 I.U, 100,000 I.U, 250,000 I.U, 500,000 I.U INFORMATION FOR HEALTH PROFESSIONALS 1. NAME OF THE MEDICINAL PRODUCT Urokinase medac 10,000 I.U. Urokinase medac 50,000 I.U. Urokinase medac 100,000 I.U. Urokinase medac 250,000 I.U. Urokinase medac 500,000 I.U. Powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial of Urokinase medac 10,000 I.U. with 24 mg of powder for solution for injection or infusion contains 10,000 IU of urokinase. 1 vial of Urokinase medac 50,000 I.U. with 38 mg of powder for solution for injection or infusion contains 50,000 IU of urokinase. 1 vial of Urokinase medac 100,000 I.U. with 39 mg of powder for solution for injection or infusion contains 100,000 IU of urokinase. 1 vial of Urokinase medac 250,000 I.U. with 63 mg of powder for solution for injection or infusion contains 250,000 IU of urokinase. 1 vial of Urokinase medac 500,000 I.U. with 125 mg of powder for solution for injection or infusion contains 500,000 IU of urokinase. For a complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for injection/infusion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Peripheral arterial thrombosis - Acute and subacute deep vein thrombosis - Acute diagnostically confirmed pulmonary embolism, in particular when associated with unstable haemodynamic status - Thrombosed arteriovenous shunt 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage: Dosages are determined in accordance with the respective indication. Peripheral arterial thrombosis Systemic lysis: For the treatment of arterial occlusion, the recommended initial dose of urokinase is 250,000 ‑ 600,000 IU given intravenously over 10 ‑ 20 minutes, with 80,000 ‑ 150,000 IU urokinase/h as a maintenance dose. Simultaneous administration of heparin is generally required to ensure adequate protection against recurre Lestu allt skjalið