Isoplate
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Uses
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).]
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Isoplate Manufacturers
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Terumo Bct Ltd.
![Isoplate (Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Phosphate, Monobasic) Solution [Terumo Bct Ltd.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isoplate | Terumo Bct Ltd.
2.1 General Dosing InformationISOPLATE 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.
2.2 Administration Ensure solution is the ISOPLATE SOLUTION and is within the expiration date. Inspect the bag. Do not use if the container is damaged, leaking or if there is any visible sign of deterioration. Use only if solution is clear and free of particulate matter. Protect from sharp objects.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:
Remove the overwrap by pulling down at notch, and remove the ISOPLATE SOLUTION bag. Before use, perform the following checks [See Warnings and Precautions (5).]: Check for leaks by squeezing the bag. If leaks are found, discard bag. Ensure the solution is the ISOPLATE SOLUTION and is within the expiration date. Inspect the solution in good light. Bags showing cloudiness, haze, or particulate matter should not be used. Remove the protective cap from the port on the bag. Connect the bag to the Trima Accel system tubing set using aseptic technique and hang the solution. Break the frangible connector. When you break frangible connectors, bend them in both directions to ensure that you break them completely. Failure to do so may result in restricted flow. Proceed per the Trima Accel system operator's manual.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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