Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B, SODIUM CATION - UNII:LYR4M0NH37), SODIUM ACETATE (UNII: 4550K0SC9B) (ACETATE ION - UNII:569DQM74SC, SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNI
Terumo BCT Ltd.
SODIUM CHLORIDE
SODIUM CHLORIDE 0.53 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system [See Dosage and Administration (2).] Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106 /µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)] [See Clinical Studies (14).] DO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS.
ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is a clear solution supplied in sterile and nonpyrogenic polyolefin bags. The ISOPLATE SOLUTION bags are packaged 18 bags per case. STORAGE Store up to 25 °C [See USP Controlled Room Temperature]. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% ISOPLATE SOLUTION and 35% plasma. Platelets in the solution can be stored at a concentration range of 0.7 to 2.1 × 106/µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)].
New Drug Application
ISOPLATE- SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC SOLUTION TERUMO BCT LTD. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ISOPLATE SOLUTION - PLATELET ADDITIVE SOLUTION [PAS-F] SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ISOPLATE SOLUTION - PLATELET ADDITIVE SOLUTION [PAS-F]. ISOPLATE SOLUTION PLATELET ADDITIVE SOLUTION [PAS-F] STERILE FLUID POLYOLEFIN BAG INITIAL U.S. APPROVAL: 2013 RECENT MAJOR CHANGES Dosage and Administration (2.2) 5/2015 INDICATIONS AND USAGE ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution to replace a portion of the plasma to store Platelets Pheresis Platelet Additive Solution (PAS) Added Leukocytes Reduced products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system. Platelets Pheresis PAS Added Leukocytes Reduced products are stored in a mix of 65% Isoplate and 35% plasma. Platelets in ISOPLATE SOLUTION can be stored at a concentration range of 0.7 to 2.1 × 10 /µL for up to 5 days at 20-24 °C with continuous agitation in the Terumo BCT ELP bag [citrated polyvinyl chloride (PVC)]. (1) DOSAGE AND ADMINISTRATION ISOPLATE SOLUTION is added to hyperconcentrated platelets after the apheresis procedure is complete. (2) ISOPLATE SOLUTION may only be used with the Trima Accel system. For instructions on the use of the solution with the Trima Accel system, see the Trima Accel system operator's manual. (2.1) Follow the directions for connecting the ISOPLATE SOLUTION bag to the Trima Accel System. (2.2) DOSAGE FORMS AND STRENGTHS 500 mL sterile fluid in polyolefin bag (3) CONTRAINDICATIONS DO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS. (4) WARNINGS AND PRECAUTIONS Verify that the ISOPLATE SOLUTION has been securely attached to the platelet additive solution line on the Trima Accel system tubing set using aseptic technique. (5) ADVER Leggi il documento completo