Anticoagulant Citrate Dextrose A

ANTICOAGULANT CITRATE DEXTROSE A- dextrose monohydrate, anhydrous citric acid and trisodium citrate dihydrate solution
Citra Labs LLC

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.

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

NOT FOR DIRECT INTRAVENOUS INFUSION

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.

Information for Patients

None.

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.

Adverse Reactions to Anticoagulant Citrate Dextrose A

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.

Rx Only

Caution: Federal Law (US) restricts this devise to sale by or on the order of a Physician.

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

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.

Manufactured & Distributed by:
Citra Labs™
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

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

ANTICOAGULANT CITRATE DEXTROSE A anhydrous citric acid, dextrose monohydrate, and trisodium citrate dihydrate solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23731-6051 Route of Administration EXTRACORPOREAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROSE MONOHYDRATE (ANHYDROUS DEXTROSE) DEXTROSE MONOHYDRATE 0.245 g in 10 mL ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 0.073 g in 10 mL TRISODIUM CITRATE DIHYDRATE (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 0.22 g in 10 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:23731-6051-3 30 mL in 1 VIAL, SINGLE-USE None 2 NDC:23731-6051-1 10 VIAL, SINGLE-USE in 1 CASE contains a VIAL, SINGLE-USE (23731-6051-3) 2 NDC:23731-6051-3 30 mL in 1 VIAL, SINGLE-USE This package is contained within the CASE (23731-6051-1) 3 NDC:23731-6051-2 25 VIAL, SINGLE-USE in 1 CASE contains a VIAL, SINGLE-USE (23731-6051-3) 3 NDC:23731-6051-3 30 mL in 1 VIAL, SINGLE-USE This package is contained within the CASE (23731-6051-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA BN020037 08/26/2003

Labeler — Citra Labs LLC (962863838)

Establishment
Name	Address	ID/FEI	Operations
Citra Labs LLC		962863838	MANUFACTURE (23731-6051)

Revised: 02/2023 Citra Labs LLC