Land: Indonesië
Taal: Indonesisch
Bron: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TENECTEPLASE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
TENECTEPLASE
10.000 U
SERBUK INJEKSI
DUS, 1 VIAL @ 10000 UNIT+1 PFS PELARUT @ 10 ML
BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG - Federal Republic of Germany
2019-07-29
PT. BOEHRINGER LNGELHEIM INDONESIA Medical and Regulatory Affairs PRODUCT INFORMATION No. 0245-06 METALYSE ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION COMPOSITION METALYSE" 8,000 units: 1 vial contains 8,000 units (4 0 mg) tenecteplase 1 pre-filled syringe contains 8 ml water for injections METALYSE" 10,000 units: 1 vial contains 10,000 units (50 mg) tenecteplase 1 pre-filled syringe contains 10 ml water for injections Excipients:•• L-arginine, phosphoric acid, polysorbate 20 trace residue: gentamicin from manufacturing process The reconstituted solution contains 1,000 units (5 mg) tenecteplase per ml. 1. December 09, 2013 Potency of tenecteplase is expressed in units (U) by using a reference standard which is specific for tenecteplase and is not comparable with units used for other thrombolytic agents. INDICATIONS METALYSE" is indicated for the thrombolytic treatment of acute myocardial infarction (AMI). Treatment should be initiated as soon as possible after symptom onset DOSAGE AND ADMINISTRATION METALYSE" should be administered on the basis of body weight , with a maximum dose of 10,000 units (50 mg tenecteplase). The volume required to administer the correct dose can be calculated from the following scheme: Patients' body weight category Tenecteplase Tenecteplase Corresponding volume of re-constituted (kg) (U) (mg) solution (ml) <60 6,000 3 0 6 �60to<70 7,000 35 7 �70to<80 8,000 4 0 8 � 80to < 90 9,000 45 9 �90 10,000 50 10 The required dose should be administered as a single intravenous bolus over 5 to 10 seconds. Remarks: BLACK (Current CCDS 0245-02); BLUE (Proses at BPOM CCDS 0245-03to 05) RED (Proposed as update CCDS 0245-06) Lees het volledige document