Anticoagulant Citrate Dextrose A

Name: 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 patient use only, on a single occasion.

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

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 U.K. Ltd.
Waterton Industrial Estate
Bridgend, South Wales, CF31 3XA
Great Britain
United Kingdom
Phone 441.65.66.55.221

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