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 g |
| Sodium Citrate, dihydrate, USP | 0.220 g |
| Dextrose, monohydrate, USP | 0.245 g |
| 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.
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.
Precautions
General
- Aseptic technique must be maintained at all times.
- ACD-A solution is a clear and colorless solution. If the product shows any cloudiness or turbidity, the product should be discarded.
- The closure system provides a biological barrier and should be intact – discard product if system is compromised.
Carcinogenesis, mutagenesis, impairment of fertility
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.
Adverse Reactions
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)
| REF | SIZE | CASE | |
|---|---|---|---|
| PN 9350-10 | 30 mL | 10 Vials/Case | |
| PN 9350-25 | 30 mL | 25 Vials/Case |
Manufactured & Distributed by:
CitraLabs™
55 Messina Drive, Braintree, MA 02184
Phone Number: 1-800-299-3411
Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands
PRINCIPAL DISPLAY PANEL - 10 Vial Case Label
C E 0044
ACD-A
Anticoagulant Citrate Dextrose Solution,
10 Vials / Case Solution A, U.S.P., ACD-A, 30 mL
REF PN 9350-10
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:
CitraLabs
A Biomet Inc. Company.
Citra Labs, LLC.
55 Messina Drive, Braintree, MA 02184
1-800-299-3411
EC REP
Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands
STERILE • NON-PYROGENIC
Composition per 10 mL of Solution:
Citric Acid, (Anhydrous), U.S.P. 0.073 g.
Sodium Citrate, (Dihydrate), U.S.P. 0.220 g.
Dextrose, (Monohydrate), U.S.P. 0.245 g.
CAUTION: Single Procedure Use-Discard Unused Portion
Do Not Use Unless Solution is Clear and Seal is Intact.
Store Between 15 °C - 30 °C (59 °F - 86 °F).
RX Only:
EXP DATE
LOT
LA9350-10B 01/20
PRINCIPAL DISPLAY PANEL - 25 Vial Case Label
C E 0044
ACD-A
Anticoagulant Citrate Dextrose Solution,
25 Vials / Case Solution A, U.S.P., ACD-A, 30 mL
REF PN 9350-25
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:
CitraLabs
A Biomet Inc. Company.
Citra Labs, LLC.
55 Messina Drive, Braintree, MA 02184
1-800-299-3411
EC REP
Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands
STERILE • NON-PYROGENIC
Composition per 10 mL of Solution:
Citric Acid, (Anhydrous), U.S.P. 0.073 g.
Sodium Citrate, (Dihydrate), U.S.P. 0.220 g.
Dextrose, (Monohydrate), U.S.P. 0.245 g.
CAUTION: Single Procedure Use-Discard Unused Portion
Do Not Use Unless Solution is Clear and Seal is Intact.
Store Between 15 °C - 30 °C (59 °F - 86 °F).
RX Only:
EXP DATE
LOT
LA9350-25 01/20
