FDA Label for As 3
View Indications, Usage & Precautions
As 3 Product Label
The following document was submitted to the FDA by the labeler of this product Terumo Bct Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Catalog # 777965-000
6 x 6 x 100 mL units
NDC 14537-966-10
Canada DIN 02324393
Caution: Not for direct intravenous infusion.
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
777965-065
Lot
Expiry Date
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.
Recommended Storage
Room temperature.
Avoid excessive heat. Protect from freezing.
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 |
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
TERUMOBCT
777965-065
Lot
Expiry Date
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