Anticoagulant Citrate Dextrose A Prescribing Information

Package insert / product label
Generic name: anhydrous citric acid, dextrose monohydrate, and trisodium citrate dihydrate
Dosage form: solution

Anticoagulant Citrate Dextrose A 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 use Single patient use only, on a single occasion.

Anticoagulant Citrate Dextrose A - 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 for Anticoagulant Citrate Dextrose A

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/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).

Anticoagulant Citrate Dextrose A 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 is Anticoagulant Citrate Dextrose A 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:
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

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

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