Label: AS 3- dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine injection, solution
- NDC Code(s): 14537-966-10, 14537-966-20
- Packager: Terumo BCT Ltd
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 4, 2018
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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.
- SPL UNCLASSIFIED SECTION
- Recommended storage
- HOW SUPPLIED
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PRINCIPAL DISPLAY PANEL - 100 mL Label
Additive Solution Formula 3 AS-3
Catalog # 777965-000
6 x 6 x 100 mL unitsNDC 14537-966-10
Canada DIN 02324393Intended 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 L4Z1S1TERUMOBCT
777965-065Lot
Expiry Date
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INGREDIENTS AND APPEARANCE
AS 3
dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14537-966 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextrose Monohydrate (UNII: LX22YL083G) (Anhydrous Dextrose - UNII:5SL0G7R0OK) Dextrose Monohydrate 1.1 g in 100 mL SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) (Anhydrous Citric Acid - UNII:XF417D3PSL) SODIUM CITRATE, UNSPECIFIED FORM 0.588 g in 100 mL Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698) Sodium Chloride 0.41 g in 100 mL Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (Phosphate Ion - UNII:NK08V8K8HR) Sodium Phosphate, Monobasic, Monohydrate 0.276 g in 100 mL Citric Acid Monohydrate (UNII: 2968PHW8QP) (Anhydrous Citric Acid - UNII:XF417D3PSL) Anhydrous Citric Acid 0.042 g in 100 mL Adenine (UNII: JAC85A2161) (Adenine - UNII:JAC85A2161) Adenine 0.03 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14537-966-10 6 in 1 CASE 1 6 in 1 POUCH 1 100 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 2 NDC:14537-966-20 30 in 1 CASE 2 200 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN001214 05/29/2002 Labeler - Terumo BCT Ltd (233649834) Establishment Name Address ID/FEI Business Operations Terumo BCT Ltd. 233649834 MANUFACTURE(14537-966) , STERILIZE(14537-966) , LABEL(14537-966) , ANALYSIS(14537-966)
