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NSN 6505-01-691-6941  ·  NIIN 016916941  ·  FSC 6505
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TENECTEPLASE FOR INJECTION KIT

Drugs and Biologicals

Technical characteristics

2 rows

Straight from the federal item record. Entries the record leaves empty are shown empty — nothing is filled in on its behalf.

Technical characteristics from the federal item record
MRCRequirementValue
CXCYPART NAME ASSIGNED BY CONTROLLING AGENCYTENECTEPLASE INTRAVENOUS KIT, 50MG
FEATSPECIAL FEATURESINDICATED FOR USE IN THE REDUCTION OF MORTALITY ASSOCIATED WITH ACUTE MYOCARDIAL INFARCTION (AMI); TISSUE PLASMINOGEN ACTIVATOR (TPA) PRODUCED BY RECOMBINANT DNA TECHNOLOGY USING AN ESTABLISHED MAMMALIAN CELL LINE (CHINESE HAMSTER OVARY CELLS); STORE LYOPHILIZED TNKASE AT CONTROLLED ROOM TEMPERATURE NOT TO EXCEED 30 C (86 F) OR UNDER REFRIGERATION 2 TO 8 C (36 TO 46 F); DO NOT USE BEYOND THE EXPIRATION DATE STAMPED ON THE VIAL; FOR USE IN MYOCARDIAL INFARCTION; FOR INTRAVENOUS ADMINISTRATION ONLY; EACH KIT CONTAINS ONE 50 MG VIAIAL OF TNKASE, ONE 10 ML VIAL OF PRESERVATIVE-FREE STERILE WATER FOR INJECTION, USP, ONE BD 10 ML SYRINGE WITH TWINPAK DUAL CANNULA DEVICE, AND PACKAGE INSERT CONTAINING FULL PRESCRIBING INFORMATION; VIAL CONTENTS: THE PRESERVATIVE-FREE SINGLE-USE VIAL OF TNKASE CONTAINS 52.5 MG TENECTEPLASE, 0.55 G L-ARGININE, 0.17 G PHOSPHORIC ACID, AND 4.3 MG POLYSORBATE 20, UNDER PARTIAL VACUUM. NO U.S. STANDARD OF POTENCY; 36 MONTHS SHELF LIFE.