Anticoagulant Citrate Dextrose A

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).

Contraindications NOT FOR DIRECT INTRAVENOUS INFUSION

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. single use

Dosage and Administration Refer to the manufacturer's Operator's Manual of the Autologous PRP System for the Directions for Use.

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.

Warnings NOT FOR DIRECT INTRAVENOUS INFUSION

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).

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.

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Anticoagulant Citrate Dextrose A Anhydrous Citric Acid, Dextrose Monohydrate, and Trisodium Citrate Dihydrate DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE ANHYDROUS CITRIC ACID ANHYDROUS CITRIC ACID TRISODIUM CITRATE DIHYDRATE ANHYDROUS CITRIC ACID

Carcinogenesis, mutagenesis, impairment of fertility Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ACD-A.

BN020037

Anticoagulant Citrate Dextrose A

Anhydrous Citric Acid, Dextrose Monohydrate, and Trisodium Citrate Dihydrate

23731-6051

HUMAN PRESCRIPTION DRUG

EXTRACORPOREAL

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: Citra Labs 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 symbols label

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

Information for Patients None.

Pediatric Use The safety and effectiveness of ACD-A in children have not been established.

Pregnancy Long-term studies in animals have not been performed to evaluate the effects of ACD- A on pregnant women.

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.

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.

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.

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.