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% ISOP...
ISOPLATE SOLUTION is added to hyperconcentrated platelets after the apheresis procedure is complete. It is not intended for direct intravenous infusion. ISOPLATE SOLUTION may only be used with the Trima Accel system for automated blood collection. For instructions on the use of the solution with the Trima Accel system, see the Trima Accel system operator's manual. Ensure solution is the ISOPLATE SOLUTION and is wi...
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. SIZE CATALOG NUMBER NDC NUMBER 500 mL 40850 14537-408-50 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...
www.fda.gov/medwatchISOPLATE 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).]
ISOPLATE SOLUTION is added to hyperconcentrated platelets after the apheresis procedure is complete. It is not intended for direct intravenous infusion.
ISOPLATE SOLUTION may only be used with the Trima Accel system for automated blood collection. For instructions on the use of the solution with the Trima Accel system, see the Trima Accel system operator's manual.
Directions for Connecting the ISOPLATE SOLUTION Bag to the Trima Accel System
At the prompt to connect the platelet additive solution to the Trima Accel system tubing set:
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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 Acetate Trihydrate 0.37 g; Potassium Chloride 0.037 g; Magnesium Chloride Hexahydrate 0.03 g; Dibasic Sodium Phosphate Dihydrate 0.008 g; Monobasic Potassium Phosphate 0.00082 g; in Water for Injection.
DO NOT INFUSE ISOPLATE SOLUTION DIRECTLY TO THE PATIENTS.
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 with platelet transfusion.
No adverse reactions were reported in the subjects infused with < 10 mL of radiolabeled platelets stored for 5 days in 65% ISOPLATE SOLUTION, and rinsed prior to infusion [See Clinical Studies (14).]
ISOPLATE SOLUTION has not been adequately studied in controlled clinical trials with specific populations.
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 products collected using a hyperconcentrated collection on Terumo BCT's Trima Accel system.
The solution is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents.
The formulas of the active ingredients are provided in Table 1.
| Ingredients | Molecular Formula | Molecular Weight |
|---|---|---|
| Sodium Chloride USP | NaCl | 58.44 |
| Sodium Acetate Trihydrate USP | CH3COONa∙3H2O | 136.08 |
| Potassium Chloride USP | KCl | 74.55 |
| Magnesium Chloride Hexahydrate USP | MgCl2∙6H2O | 203.30 |
| Dibasic Sodium Phosphate Dihydrate USP | Na2HPO4∙2H2O | 177.98 |
| Monobasic Potassium Phosphate NF | KH2PO4 | 136.09 |
| Sodium Gluconate USP | C6H11NaO7 | 218.14 |
Each 100 mL of ISOPLATE SOLUTION contains: Sodium Chloride USP 0.53 g; Sodium Gluconate USP 0.5 g; Sodium Acetate Trihydrate USP 0.37 g; Potassium Chloride USP 0.037 g; Magnesium Chloride Hexahydrate USP 0.03 g; Dibasic Sodium Phosphate Dihydrate USP 0.008 g; Monobasic Potassium Phosphate NF 0.00082 g; in Water for Injection USP.
pH may be adjusted with glacial Acetic Acid USP or Sodium Hydroxide NF pH: 7.4 (7.0-7.8).
Concentration of Electrolytes (mEq/liter): Sodium 141; Potassium 5; Magnesium 3; Chloride 98; Phosphate (HPO=4 ) 1 (0.5 mmole P/liter); Acetate (CH3COO–) 27; Gluconate (HOCH2(CHOH)4COO–) 23.
The polyolefin bag is not made with natural rubber latex or PVC. Di(2-ethylhexyl)phthalate (DEHP) is present only in sterile dock tube.
The bag is made from a multilayered film. It contains materials that have been tested to demonstrate the suitability of the container for storing pharmaceutical solutions. The solution contact layer is an elasticized polyolefin. The bag is nontoxic and biologically inert. The bag-solution unit is a closed system and is not dependent upon entry of external air during administration. The bag is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
ISOPLATE SOLUTION contains the following key components to maintain platelet function:
This solution has no pharmacological effect; the solution provides the appropriate components for platelet function while allowing for a lower volume of plasma in the platelet product during storage.
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 by apheresis on the Trima Accel system, diluted in ISOPLATE SOLUTION, and stored for five days (Test) meet FDA acceptance criteria in comparison with fresh autologous platelets (Control). Table 2 summarizes the in vivo radiolabeled platelet recovery and survival data.
| Recovery | Survival | |||||
|---|---|---|---|---|---|---|
| Test | Control | Test/Control | Test | Control | Test/Control | |
| % | % | % | Days | Days | % | |
| Average | 51.1 | 60.2 | 85 | 6.6 | 8.7 | 76 |
| St. Dev. | 10.9 | 10.2 | 10 | 1.2 | 0.9 | 12 |
| Min | 32.6 | 40.4 | 66 | 4.5 | 6.4 | 52 |
| Max | 84.1 | 82.8 | 102 | 8.8 | 10.0 | 104 |
The primary outcomes for this study were:
Recovery: Test minus 66% Control is equal to or greater than zero with one-sided 97.5% confidence limit
Survival: Test minus 58% Control is equal to or greater than zero with one-sided 97.5% confidence limit
Both primary outcomes were met for hyperconcentrated leukocyte reduced platelets collected on the Trima Accel system and stored in ISOPLATE SOLUTION.
In Vitro Platelet Quality Study
A paired study was completed to verify that in vitro platelet quality (functional assays) of hyperconcentrated leukocyte reduced platelets collected by apheresis on the Trima Accel system, diluted in ISOPLATE SOLUTION, and stored for five days (Test) meet FDA acceptance criteria in comparison to plasma-stored platelets (Control). Table 3 summarizes the in vitro platelet quality data.
| Functional Assay | Isoplate Stored Apheresis Platelets (Test) Average (Standard Deviation) | Plasma Stored Apheresis Platelets (Control) Average (Standard Deviation) |
|---|---|---|
| pH | 7.4 (0.2) | 7.5 (0.1) |
| CD62 Expression; P-Selectin (%) | 22.8 (15.6) | 15.0 (9.8) |
| Morphology Score (Max Score 400) | 289 (49) | 292 (47) |
| Hypotonic Shock Response (%) | 53.3 (12.4) | 55.9 (10.9) |
| Extent of Shape Change (%) | 23.2 (5.0) | 25.0 (6.0) |
The primary outcome for this study was:
pH: 95% or more of test units will have a pH (22 °C) greater than 6.2 with a one-sided confidence interval of 95%
All 66 platelet products collected in this study had pH > 6.2 therefore the primary outcome for pH was met for hyperconcetrated platelets collected on the Trima Accel system and stored in ISOPLATE SOLUTION.
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.
| SIZE | CATALOG NUMBER | NDC NUMBER |
|---|---|---|
| 500 mL | 40850 | 14537-408-50 |
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)].
Issued: May 2015
Manufactured by
Terumo BCT, Inc.
Lakewood, CO 80215 USA
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 intact. Rx only. Single use container.
Caution: Not for direct intravenous infusion.
Recommended storage: Store up to 25 °C (See USP Controlled Room
Temperature).
Each 100 mL contains:
Sodium Chloride USP 0.53 g
Sodium Gluconate USP 0.5 g
Sodium Acetate Trihydrate USP 0.37 g
Potassium Chloride USP 0.037 g
Magnesium Chloride Hexahydrate USP 0.03 g
Dibasic Sodium Phosphate Dihydrate USP 0.008 g
Monobasic Potassium Phosphate NF 0.00082 g
In Water for Injection USP
Manufactured by Terumo BCT, Inc.
10811 W. Collins Ave., Lakewood CO 80215, USA
777969-551
TERUMOBCT
Lot
Expiry Date
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 14537-408 | ISOPLATE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATE, MONOBASIC) SOLUTION [TERUMO BCT LTD.] | 7 | Legacy NDC | 20250125_37932532-4fbf-4485-abe6-d2c9f9fc3b80.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MAGNESIUM CHLORIDE | ACTIVE INGREDIENT | 02F3473H9O | 5 | |
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | 5 | |
| POTASSIUM PHOSPHATE, MONOBASIC | ACTIVE INGREDIENT | 4J9FJ0HL51 | 5 | |
| SODIUM ACETATE | ACTIVE INGREDIENT | 4550K0SC9B | 5 | |
| SODIUM CHLORIDE | ACTIVE INGREDIENT | 451W47IQ8X | 5 | |
| SODIUM GLUCONATE | ACTIVE INGREDIENT | R6Q3791S76 | 5 | |
| SODIUM PHOSPHATE, DIBASIC | ACTIVE INGREDIENT | GR686LBA74 | 5 | |
| CHLORIDE ION | ACTIVE MOIETY | Q32ZN48698 | 5 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 5 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 14537-408 | 14537-408-50 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| SODIUM GLUCONATE | R6Q3791S76 | ACTIB |
| SODIUM ACETATE | 4550K0SC9B | ACTIB |
| POTASSIUM CHLORIDE | 660YQ98I10 | ACTIB |
| MAGNESIUM CHLORIDE | 02F3473H9O | ACTIB |
| SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM | GR686LBA74 | ACTIB |
| MONOBASIC POTASSIUM PHOSPHATE | 4J9FJ0HL51 | ACTIB |
| WATER | 059QF0KO0R | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9aba3154-40ee-45f3-b9d1-42588be50c4b | 37932532-4fbf-4485-abe6-d2c9f9fc3b80 | 2025-07-09 | Warnings, Adverse reactions | 37932532-4fbf-4485-abe6-d2c9f9fc3b80 |
Adverse event summaries are temporarily unavailable. Other product information remains available.