ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE AND AS-5 RED CELL PRESERVATIVE

Electrolyte / Mineral

Oral

Mechanism of Action

12.1. Mechanism of Action CPD Mechanism of Action CITRATE PHOSPHATE DEXTROSE acts as an extracorporeal anticoagulant by binding the free calcium in the blood. Calcium is a necessary co-factor to several steps in the clotting cascade. The following ingredients are key components of the solution: Citric Acid for pH regulation Sodium Citrate functions as an anticoagulant Dextrose for isotonicity Sodium Dihydrogen Phosphate for pH buffering This solution has no clinical effect in transfused patients. AS-5 Mechanism of Action ADDITIVE SOLUTION FORMULA 5 acts to preserve and extend the shelf life of packed RBC products for later transfusion to patients. The following ingredients are key components of the solution: Dextrose for RBC nutrition Sodium Chloride for isotonicity Mannitol to protect RBC membranes Adenine to support adenosine triphosphate (ATP) levels This solution has no clinical effect in transfused patients.

Indications

1 INDICATIONS AND USAGE The Reveos ® SELECT set is intended to collect a unit of whole blood and to process the whole blood unit on the Reveos Automated Blood Processing System

producing blood components. Rx only. The Reveos ® SELECT set is intended to collect a unit of whole blood and to process the whole blood unit on the Reveos Automated Blood Processing System

producing blood components. ( 1 ) Rx only. ( 1 )

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Single-use product
Reuse of a single-use disposable set may result in: Product performance issues due to loss of product integrity, including but not limited to the following: Fluid leaks Parts that are warped or deformed Plastics that are brittle and discolored Filters that have reduced filtration capabilities Viral infections such as hepatitis or human immunodeficiency virus (HIV) Bacterial infections Cross-contamination Any of these risks could result in serious injury or death
These risks are shared by product users, donors, patients, and recipients of the end product of the device

Known Side Effects

4 documented side effects by frequency

Nausea

1-10%

Vomiting

1-10%

Abdominal Pain

1-10%

Constipation

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral