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FDA Drug information

AS 3

Read time: 1 mins
Marketing start date: 28 Apr 2024
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Summary of product characteristics


Description

Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator's Manuals for additional information and complete usage instructions. Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact. Rx only. Single use container.

Effective Time

20181204

Version

3

Spl Product Data Elements

AS 3 Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine Dextrose Monohydrate Anhydrous Dextrose SODIUM CITRATE, UNSPECIFIED FORM Anhydrous Citric Acid Sodium Chloride Chloride Ion Sodium Phosphate, Monobasic, Monohydrate Phosphate Ion Citric Acid Monohydrate Anhydrous Citric Acid Adenine Adenine

Application Number

BN001214

Brand Name

AS 3

Generic Name

Dextrose Monohydrate, Sodium Citrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate and Adenine

Product Ndc

14537-966

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL - 100 mL Label Additive Solution Formula 3 AS-3 Catalog # 777965-000 6 x 6 x 100 mL units NDC 14537-966-10 Canada DIN 02324393 Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator's Manuals for additional information and complete usage instructions. 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: Room temperature. Avoid excessive heat. Protect from freezing. Each 100 mL contains: Dextrose Monohydrate USP 1.10 g Sodium Citrate Dihydrate USP 0.588 g Sodium Chloride USP 0.410 g Monobasic Sodium Phosphate Monohydrate USP 0.276 g Citric Acid Monohydrate USP 0.042 g Adenine USP 0.030 g In Water for Injection USP Manufactured by Terumo BCT, Inc. 10811 W. Collins Ave., Lakewood CO 80215, USA Dist in Canada: Terumo BCT (Canada), Inc., 4 Robert Speck Pkwy, Ste. 1500, Mississauga, ON, Canada L4Z1S1 TERUMO BCT 777965-065 Lot Expiry Date Principal Display Panel - 100 mL Label

Package Label Principal Display Panel Table

Dextrose Monohydrate USP 1.10 g
Sodium Citrate Dihydrate USP 0.588 g
Sodium Chloride USP 0.410 g
Monobasic Sodium Phosphate Monohydrate USP 0.276 g
Citric Acid Monohydrate USP 0.042 g
Adenine USP 0.030 g
In Water for Injection USP

Spl Unclassified Section

Catalog # 777965-000 6 x 6 x 100 mL units NDC 14537-966-10 Canada DIN 02324393

How Supplied

Each 100 mL contains: Dextrose Monohydrate USP 1.10 g Sodium Citrate Dihydrate USP 0.588 g Sodium Chloride USP 0.410 g Monobasic Sodium Phosphate Monohydrate USP 0.276 g Citric Acid Monohydrate USP 0.042 g Adenine USP 0.030 g In Water for Injection USP

How Supplied Table

Dextrose Monohydrate USP 1.10 g
Sodium Citrate Dihydrate USP 0.588 g
Sodium Chloride USP 0.410 g
Monobasic Sodium Phosphate Monohydrate USP 0.276 g
Citric Acid Monohydrate USP 0.042 g
Adenine USP 0.030 g
In Water for Injection USP

Storage And Handling

Recommended storage Room temperature. Avoid excessive heat. Protect from freezing.

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