FDA Label for Anticoagulant Citrate Dextrose A Acd-a
View Indications, Usage & Precautions
Anticoagulant Citrate Dextrose A Acd-a Product Label
The following document was submitted to the FDA by the labeler of this product Arteriocyte Medical Systems, Inc.. 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.
Caution
Not for preparation of blood products for transfusion or for direct intravenous infusion.
Recommended Storage
Room temperature (68° to 77°F, 20° to 25°C)
Avoid excessive heat. Protect from freezing.
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 |
Other
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 Ml Bag Label
Anticoagulant Citrate Dextrose Solution,
Solution A USP 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.
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
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