Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative
Generic Name: anticoagulant citrate phosphate dextrose (cpd) and as-5 red cell preservative
Brand Names:
Reveos Select Cpd With As-5 Red Cell Preservative Solution For Collection Of 500ml Of Blood
11 DESCRIPTION The Reveos SELECT set has been evaluated for use with the Reveos system. The blood and fluid pathways of the blood bag set are steam-sterilized and are non-pyrogenic. The blood bag set is intended for use by appropriately trained phlebotomists who collect whole blood and by blood center personnel who process whole blood using the Reveos system. The formulas of the active ingredients are provided in Tables 1 and 2.
Overview
11 DESCRIPTION The Reveos SELECT set has been evaluated for use with the Reveos system. The blood and fluid pathways of the blood bag set are steam-sterilized and are non-pyrogenic. The blood bag set is intended for use by appropriately trained phlebotomists who collect whole blood and by blood center personnel who process whole blood using the Reveos system. The formulas of the active ingredients are provided in Tables 1 and 2.
Uses
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 )
Dosage
2 DOSAGE AND ADMINISTRATION Follow the instructions for collecting blood with the Reveos SELECT set. ( 2 ) Follow the instructions for post-processing and red blood cell leukoreduction with the Reveos SELECT set. ( 2 ) Set Diagram 1 Whole blood bag 7 Sample/diversion bag A, C: Y connector 2 Interim platelet unit (IPU) bag 8 Needle B, G: Blue clamp 3 Plasma bag 9 Needle injury protector (NIP) D, F, H, J: CLIKTIP frangible connector 4 Plasma cryoprecipitate reduced bag 10 Sample tube holder/luer adapter E: White clamp 5 Red blood cell (RBC) bag 11 Cross-connector 6 Residual leukocyte bag 12 RBC leukoreduction filter This document provides blood collection and post-processing instructions specific to the Reveos SELECT set.
Side Effects
6. ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )
Warnings
5 WARNINGS AND PRECAUTIONS Single-use product. Do not reuse. This product is intended to be single use only and is not intended to be reused or re-sterilized in any manner. Terumo Blood and Cell Technologies cannot ensure the functionality or sterility of the product if it is reused or re-sterilized. 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. 4 CONTRAINDICATIONS None. None. ( 4 )
Storage
STORAGE Long-term storage temperature: 1 °C to 30 °C Permitted temperature excursions: –20 °C to 1 °C for up to 2 weeks Up to 50 °C for up to 1 week Use blood bag sets within 28 days after you open the outer aluminum foil pouch. To store unused blood bag sets, return them to the outer aluminum foil pouch and reclose the pouch with tape or a clip.
Frequently Asked Questions
What is Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative used for?▼
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 )
What are the side effects of Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative?▼
6. ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. To report SUSPECTED ADVERSE REACTIONS, contact Terumo BCT, Inc. at 1-877-339-4228 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )
What are the important warnings for Anticoagulant Citrate Phosphate Dextrose (cpd) And As-5 Red Cell Preservative?▼
5 WARNINGS AND PRECAUTIONS Single-use product. Do not reuse. This product is intended to be single use only and is not intended to be reused or re-sterilized in any manner. Terumo Blood and Cell Technologies cannot ensure the functionality or sterility of the product if it is reused or re-sterilized. 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. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.