Active ingredientDEXTROSE MONOHYDRATE, ANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE
Label structure14 sections
Indications and uses
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.
Dosage and administration
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
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 use Single patient use only, on a single occasion.
Clinical Pharmacology
CLINICAL PHARMACOLOGY SECTION
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
INDICATIONS & USAGE SECTION
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
CONTRAINDICATIONS SECTION
NOT FOR DIRECT INTRAVENOUS INFUSION
Warnings
WARNINGS SECTION
NOT FOR DIRECT INTRAVENOUS INFUSION
Precautions
PRECAUTIONS SECTION
General
GENERAL PRECAUTIONS SECTION
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.
Information for Patients
INFORMATION FOR PATIENTS SECTION
None.
Carcinogenesis, mutagenesis, impairment of fertility
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.
Pregnancy
PREGNANCY SECTION
Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women.
Pediatric Use
PEDIATRIC USE SECTION
The safety and effectiveness of ACD-A in children have not been established.
Adverse Reactions
ADVERSE REACTIONS SECTION
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
OVERDOSAGE SECTION
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
DOSAGE & ADMINISTRATION SECTION
Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.
Rx Only
SPL UNCLASSIFIED SECTION
Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.
How Supplied
HOW SUPPLIED SECTION
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
STORAGE AND HANDLING SECTION
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.
Authorized Representative:
Biomet Global Supply Chain Center B.V.
Hazeldonk 6530
4836 LD Breda
The Netherlands
Principal Display Panel
PRINCIPAL DISPLAY PANEL - 10 Vial Case Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
symbols
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
label
PRINCIPAL DISPLAY PANEL - 25 Vial Case Label
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
symbols
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:
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.