Label:
ISOPLATE- sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, d...
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  • 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 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 ...
  • Table of Contents
    Table of Contents
  • 1 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    500 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 ...
  • 4 CONTRAINDICATIONS
    DO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS.
  • 5 WARNINGS AND PRECAUTIONS
    Verify 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 ...
  • 6 ADVERSE REACTIONS
    ISOPLATE 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 ...
  • 8 SPECIAL POPULATIONS
    ISOPLATE SOLUTION has not been adequately studied in controlled clinical trials with specific populations.
  • 11 DESCRIPTION
    ISOPLATE 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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 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 ...
  • 14 CLINICAL STUDIES
    In 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 ...
  • 15 REFERENCES
    Gulliksson 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    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 ...
  • SPL UNCLASSIFIED SECTION
    Issued: May 2015 - Manufactured by - Terumo BCT, Inc. Lakewood, CO 80215 USA
  • PRINCIPAL DISPLAY PANEL - 500 mL Bag Label
    Isoplate 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 ...
  • INGREDIENTS AND APPEARANCE
    Product Information