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).]

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.

• 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 partially used solution bags.

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.

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.

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.

1. Gulliksson H. Platelet storage media. Transfus Apher Sci 2001;24:241-4.
2. Ringwald J, Zimmermann R, Eckstein R. The new generation of platelet additive solution for storage at 22 degrees C: development and current experience. Transfus Med Rev 2006;20:158-64.

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.

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