Isoplate

Name: Isoplate

Manufacturer

  • Terumo BCT Ltd.

Isoplate Drug Class

Isoplate is part of the drug classes:

  • Electrolyte solutions

  • Magnesium

  • POTASSIUM

  • Salt solutions

  • Sodium

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 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.

Contraindications

DO NOT INFUSE Isoplate SOLUTION DIRECTLY TO THE PATIENTS.

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 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

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 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

Isoplate 
sodium chloride, sodium gluconate, sodium acetate, potassium chloride, magnesium chloride, sodium phosphate, dibasic, and potassium phosphate, monobasic solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:14537-408
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 0.53 g  in 100 mL
SODIUM GLUCONATE (GLUCONIC ACID and SODIUM CATION) SODIUM GLUCONATE 0.5 g  in 100 mL
SODIUM ACETATE (ACETATE ION and SODIUM CATION) SODIUM ACETATE 0.37 g  in 100 mL
POTASSIUM CHLORIDE (POTASSIUM CATION and CHLORIDE ION) POTASSIUM CHLORIDE 0.037 g  in 100 mL
MAGNESIUM CHLORIDE (MAGNESIUM CATION and CHLORIDE ION) MAGNESIUM CHLORIDE 0.03 g  in 100 mL
SODIUM PHOSPHATE, DIBASIC (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC 0.008 g  in 100 mL
POTASSIUM PHOSPHATE, MONOBASIC (PHOSPHATE ION and POTASSIUM CATION) POTASSIUM PHOSPHATE, MONOBASIC 0.00082 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:14537-408-50 18 CONTAINER in 1 CASE
1 500 mL in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA BN090067 03/05/2013
Labeler - Terumo BCT Ltd. (233649834)
Revised: 05/2015   Terumo BCT Ltd.
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