Label: ISOPLATE- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, d...view full title
- NDC Code(s): 14537-408-50
- Packager: Terumo BCT Ltd.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 23, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEISOPLATE 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 General Dosing Information - ISOPLATE SOLUTION is added to hyperconcentrated platelets after the apheresis procedure is complete. It is not intended for direct intravenous infusion. ISOPLATE ...
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3 DOSAGE FORMS AND STRENGTHS500 mL ISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is a sterile isotonic solution in a polyolefin bag. Each 100 mL contains: Sodium Chloride 0.53 g; Sodium Gluconate 0.5 g; Sodium ...
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4 CONTRAINDICATIONSDO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS.
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5 WARNINGS AND PRECAUTIONSVerify that the solution bag has been securely attached to the platelet additive solution line on the Trima Accel system tubing set using aseptic technique. Do not reuse. Discard unused or ...
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6 ADVERSE REACTIONSISOPLATE SOLUTION is added to platelets after the apheresis procedure is complete. It is not for direct intravenous infusion. It is expected to cause adverse events that are normally associated ...
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8 SPECIAL POPULATIONSISOPLATE SOLUTION has not been adequately studied in controlled clinical trials with specific populations.
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11 DESCRIPTIONISOPLATE SOLUTION - Platelet Additive Solution [PAS-F] is an isotonic solution designed to replace a proportion of the plasma used in the storage of Platelet Pheresis, Leukocytes Reduced PAS ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - ISOPLATE SOLUTION contains the following key components to maintain platelet function: Sodium chloride for osmolarity - Acetate to fuel platelet metabolism - Gluconate or ...
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14 CLINICAL STUDIESIn Vivo radiolabeled recovery and survival - A paired study was completed to verify that in vivo radiolabeled recovery and survival of hyperconcentrated leukocyte reduced platelets collected ...
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15 REFERENCESGulliksson H. Platelet storage media. Transfus Apher Sci 2001;24:241-4. Ringwald J, Zimmermann R, Eckstein R. The new generation of platelet additive solution for storage at 22 degrees C ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGISOPLATE 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 ...
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SPL UNCLASSIFIED SECTIONIssued: May 2015 - Manufactured by - Terumo BCT, Inc. Lakewood, CO 80215 USA
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PRINCIPAL DISPLAY PANEL - 500 mL Bag LabelIsoplate Solution - Platelet Additive Solution [PAS-F] Catalog # 40850 - Polyolefin Bag - 500 mL - NDC 14537-408-50 - Sterile. Non-pyrogenic. Do not use unless the solution is clear and - the container is ...
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INGREDIENTS AND APPEARANCEProduct Information