ACD-A Anticoagulant Solution Good Buffer Solutions Anticoagulant Citrate Dextrose Solution

ACD-A Anticoagulant Solution Good Buffer Solutions Anticoagulant Citrate Dextrose Solution

Anticoagulant Citrate Dextrose Solution,

Solution A, U.S.P., PN 9350, 30 mL

NDC 23731-6051-3

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.

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.

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

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