Anticoagulant Citrate Dextrose A
ACD-A Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., PN 6053, 50mL
FULL PRESCRIBING INFORMATION: CONTENTS*
- Description
- Clinical Pharmacology
- Anticoagulant Citrate Dextrose A Indications and Usage
- Contraindications
- Warnings
- Precautions
- Side Effects
- Overdosage
- Dosage and Administration
- How Supplied
- PRINCIPAL DISPLAY PANEL - 50mL Bottle Label
FULL PRESCRIBING INFORMATION
Description
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A), is a sterile, non-pyrogenic solution of citric acid, sodium citrate, and dextrose, in water for injection. Each 10 mL of solution contains:
| Citric Acid, anhydrous, USP | 0.073 grams |
| Sodium Citrate, dihydrate, USP | 0.220 grams |
| Dextrose, monohydrate, USP | 0.245 grams |
| Water for Injection, USP | q.s. |
| pH: 4.5 – 5.5 |
Single patient use only, on a single occasion.
Clinical Pharmacology
ACD-A acts as an anticoagulant by the action of the citrate ion chelating free ionized calcium, thus making calcium unavailable to the coagulation system.
Anticoagulant Citrate Dextrose A Indications and Usage
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P. (ACD-A), is intended for use as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP). Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
Contraindications
NOT FOR DIRECT INTRAVENOUS INFUSION.
Warnings
None.
Precautions
General
Aseptic technique must be maintained at all times. ACD-A solution is a clear solution. If the product shows any cloudiness or turbidity, the product should be discarded. The ACD-A solution may exhibit a slight "yellow" color, which is acceptable and in no way impairs the safe use of the product. The closure system provides a biological barrier and should be intact – discard product if system is compromised.
Information for Patients
None.
Laboratory Tests
There are no laboratory tests for the drug product at this time.
Drug Interactions
ACD-A is added to whole blood without any other drug products, and therefore, there are no drug interaction concerns.
Carcinogenesis, mutagenesis, impairment of fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.
Pregnancy
Long-term studies in animals have not been performed to evaluate the effects of ACD-A on pregnant women.
Pediatric Use
The safety and effectiveness of ACD-A in children have not been established.
Side Effects
Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP Systems in production of platelet rich plasma (PRP).
Overdosage
Not applicable. This product is used as an anticoagulant in the extracorporeal blood processing with Autologous PRP systems in production of platelet rich plasma (PRP).
Dosage and Administration
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
How Supplied
Anticoagulant Citrate Dextrose Solution, Solution A, U.S.P., (ACD-A),
| NDC | REF | SIZE | CASE |
|---|---|---|---|
| 23731-6051-5 | 6053 | 50 mL Vial | 12 Vials/Case |
It is recommended that the product be stored at ambient room temperature, 24°C (75°F); however, the product can be stored between 15°C (59°F) and 30°C (86°F). Protect from freezing and exposure to excessive heat should be minimized.
Rx Only
Manufactured & Distributed by:
Citra Labs™
55 Messina Drive, Braintree, MA 02184
Phone Number: 1-800-299-3411
Authorized Representative:
Biomet U.K. Ltd.
Waterton Industrial Estate
Bridgend, South Wales, CF31 3XA
Great Britain
United Kingdom
Phone 441.65.66.55.221
FL6053 08/11
PRINCIPAL DISPLAY PANEL - 50mL Bottle Label
C E 0044
ACD-A
Anticoagulant Citrate Dextrose Solution,
Solution A, U.S.P., 50mL
REF 6053
NDC 23731-6051-5
WARNING: NOT FOR DIRECT INTRAVENOUS INFUSION.
Used as an anticoagulant in the extracorporeal blood processing with
Autologous PRP Systems in production of platelet rich plasma (PRP).
Refer to PRP Systems manufacturer's Directions for Use.
Manufactured & Distributed by:
Citra Labs™
55 Messina Drive, Braintree, MA 02184
Phone Number: 1-800-299-3411
EC REP
Authorized Representative:
Biomet U.K. Ltd.
Waterton Industrial Estate
Bridgend, South Wales, CF31 3XA
Great Britain
United Kingdom
Phone 441.65.66.55.221
Anticoagulant Citrate Dextrose AANHYDROUS CITRIC ACID, DEXTROSE MONOHYDRATE, and TRISODIUM CITRATE DIHYDRATE SOLUTION
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
