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FDA Drug information

Anticoagulant Citrate Dextrose A ACD-A

Read time: 1 mins
Marketing start date: 18 Nov 2024
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Summary of product characteristics


Description

Each 10mL contains Citric Acid Monohydrate USP 0.08 g Sodium Citrate Dihydrate USP 0.220 g Dextrose Monohydrate USP 0.245 g In Water for Injection USP

Effective Time

20181217

Version

3

Description Table

Citric Acid Monohydrate USP 0.08 g
Sodium Citrate Dihydrate USP 0.220 g
Dextrose Monohydrate USP 0.245 g
In Water for Injection USP

Spl Product Data Elements

Anticoagulant Citrate Dextrose A ACD-A Anticoagulant Citrate Dextrose A ACD-A CITRIC ACID MONOHYDRATE ANHYDROUS CITRIC ACID SODIUM CITRATE, UNSPECIFIED FORM SODIUM CATION DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE Water

Application Number

BA110057

Brand Name

Anticoagulant Citrate Dextrose A ACD-A

Generic Name

Anticoagulant Citrate Dextrose A ACD-A

Product Ndc

43203-852

Product Type

HUMAN PRESCRIPTION DRUG

Route

EXTRACORPOREAL

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label Anticoagulant Citrate Dextrose Solution, Solution A USP ACD-A 50 mL 50 x 50 mL Catalog # AMSACD-A Anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. 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 and undamaged. Rx only. Single use container. Caution: Not for preparation of blood products for transfusion or for direct intravenous infusion. Storage Conditions: Room temperature (68° to 77°F, 20° to 25°C) Avoid excessive heat. Protect from freezing. Protect from direct sunlight. Each 10mL contains: Citric Acid Monohydrate USP 0.08 g Sodium Citrate Dihydrate USP 0.220 g Dextrose Monohydrate USP 0.245 g In Water for Injection USP Manufactured for Arteriocyte Medical Systems, Inc. 45 South Street, Hopkinton, MA., 01748 by Ivex Pharmaceuticals, Larne, BT40 2SH, UK. ARTERIOCYTE CELLULAR THERAPIES MEDICAL SYSTEMS Lot Expiry Date PRINCIPAL DISPLAY PANEL - 50 Pouch Case Label

Spl Unclassified Section

ACD-A 50 mL Catalog # AMSACD-A Anticoagulant intended for use only with devices that prepare Platelet Rich Plasma (PRP) products for extracorporeal use. 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 and undamaged. Rx only. Single use container.

Storage And Handling

Recommended storage Room temperature (68° to 77°F, 20° to 25°C) Avoid excessive heat. Protect from freezing.

Precautions

Caution Not for preparation of blood products for transfusion or for direct intravenous infusion.

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