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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).]
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.