Anticoagulant Citrate Dextrose Solution,

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Citric Acid (0.08 g) Sodium Cation (0.220 g) Anhydrous Dextrose (0.245 g)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2011-05-11

Medication Information

Description

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.

Section 42229-5

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.

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

Recommended Storage

Room temperature (68° to 77°F, 20° to 25°C)

Avoid excessive heat. Protect from freezing.

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

Structured Label Content

Section 42229-5 (42229-5)

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.

Each 10ml Contains (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

Recommended Storage (Recommended storage)

Room temperature (68° to 77°F, 20° to 25°C)

Avoid excessive heat. Protect from freezing.

Principal Display Panel 50 Pouch Case Label (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

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "ACTIM", "strengthNumerator": "0.08", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "0.220", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS DEXTROSE", "unii": "5SL0G7R0OK", "classCode": "ACTIB", "strengthNumerator": "0.245", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "9.76", "strengthDenominator": "10", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"42229-5": "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.", "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", "Recommended storage": "Room temperature (68° to 77°F, 20° to 25°C) Avoid excessive heat. Protect from freezing.", "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"}

Anticoagulant Citrate Dextrose Solution,

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information