Reveos Select CPD/AS-5 Red Cell Preservative For Collection Of Blood

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 )

4 CONTRAINDICATIONS None. None. ( 4 )

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. Table 1: CPD Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose (anhydrous) C 6 H 12 O 6 180.16 g/mol Trisodium Citrate (dihydrate) C 6 H 5 Na 3 O 7 2H 2 O 294.10 g/mol Citric Acid (monohydrate) C 6 H 8 O 7 H 2 O 210.14 g/mol Sodium Dihydrogen Phosphate (dihydrate) NaH 2 PO 4 2H 2 O 156.01 g/mol Water for Injection H 2 O 18.02 g/mol Each 70 mL of CPD contains: Dextrose (anhydrous) 1.624 g, Trisodium Citrate (dihydrate) 1.841 g, Citric Acid (monohydrate) 0.229 g, Sodium Dihydrogen Phosphate (dihydrate) 0.176 g, and water for injection up to 70 mL. Table 2: AS-5 Active Ingredients Ingredients Molecular Formula Molecular Weight Dextrose (anhydrous) C 6 H 12 O 6 180.16 g/ mol Sodium Chloride NaCl 58.44 g/mol Mannitol C 6 H 14 O 6 182.17 g/mol Adenine C 5 H 5 N 5 135.13 g/mol Water for injection H 2 O 18.02 g/mol Each 111 mL of AS-5 contains: Dextrose (anhydrous) 0.908 g, Sodium Chloride 0.973 g, Mannitol 0.583 g, Adenine 0.035 g, and water for injection up to 111 mL. The PVC plasticized with DEHP bags are not made with natural rubber latex. The bags contain materials that have been tested to demonstrate the suitability of the containers for storing pharmaceutical solutions. The bags are nontoxic and biologically inert. The blood bag set is a closed system and is not dependent upon entry of external air during administration. The blood bag set is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

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. For warnings, cautions, and instructions on processing whole blood with the Reveos system, see the Reveos system operator's manual. Note : Refer to the instructions for use provided by the manufacturer of your tubing sealer to ensure that the tubing sealer is appropriate for the tubing on the blood bag set. Note : You must validate the process for producing, storing, and handling Cryoprecipitated Antihemophilic Factor within your institution's standard operating procedure (SOP), including procedures for using the plasma cryoprecipitate reduced bag. Blood Collection Required Supplies: • Scale and/or blood mixing device • Tubing sealer • Evacuated blood collection tubes 1. If it is part of your institution's SOP, make a loose knot in the collection tubing between white clamp E and the whole blood bag. 2. Separate the sample/diversion bag from the other bags. 3. Load the bags onto a scale and/or blood mixing device according to your institution's SOP. Ensure that the whole blood bag and the sample bag are lower than the donor's arm. 4. Close blue clamp B. 5. Apply a blood pressure cuff or a tourniquet to the donor's arm. 6. Prepare the venipuncture site. 7. Twist the needle cap until the resistance stops and then pull the needle cap straight off. 8. Perform the venipuncture according to your institution's SOP. 9. Open blue clamp B. 10. Position the sample/diversion bag with blue clamp B at the top and the sample tube holder/luer adapter at the bottom (see Figure 1 ). Allow the desired volume of whole blood to flow into the sample/diversion bag. The nominal volume of the sample bag is 60 mL. When the volume reaches the marking, approximately 40 mL has been collected. 11. Close blue clamp B. 12. Break CLIKTIP D to allow the whole blood to flow into the whole blood bag. Bend the CLIKTIP in both directions to ensure that you break it completely. 13. Seal the sample/diversion tubing as near as possible to Y connector A. Seal the tubing according to your institution's SOP. 14. Invert the sample/diversion bag and transfer donor blood samples from the sample/diversion bag, using evacuated blood collection tubes. Transfer samples as soon as possible after venipuncture to avoid possible clot formation in the sample/diversion bag. a. Hold the sample/diversion bag and sample tube holder/luer adapter in one hand with blue clamp B positioned at the bottom (see Figure 2 ). b. Using the other hand, insert a blood collection tube firmly into the sample tube holder/luer adapter. After filling the blood collection tube, remove the tube from the sample tube holder. Repeat the process to take additional samples. 15. Mix the whole blood and the anticoagulant during collection according to your institution's SOP. 16. Collect the target volume of blood ± 10%, as specified on the whole blood bag label. 17. Close white clamp E and perform one of the following steps: If you made a knot in the collection tubing in step 1, tighten the knot firmly. If you did not make a knot in step 1, seal the collection tubing near CLIKTIP D. 18. Hold the needle hub and then slide the NIP partially over the needle hub (see Figure 3 ). 19. Gently pull on the tubing to withdraw the needle from the donor's arm and into the NIP until the needle locks securely (see Figure 4 ). 20. Seal the collection tubing near CLIKTIP D if you did not do so in step 17. Disconnect the sealed tubing that includes the needle and the sampling assembly. Dispose of the needle, the NIP, and the sample tube holder safely according to your institution's SOP and/or local regulations. 21. Immediately after collection is complete, invert the whole blood bag several times to thoroughly mix the whole blood and the anticoagulant. 22. If required, strip the blood in the collection tubing into the whole blood bag according to your institution's SOP. 23. Seal and disconnect the collection tubing between 1 in and 2 in (2.5 cm and 5.0 cm) away from the whole blood bag. Dispose of the collection tubing safely according to your institution's SOP and/or local regulations. 24. Place the whole blood unit into a temperature-controlled environment according to your institution's SOP. 25. Pack and transport the whole blood unit to the processing laboratory according to your institution's SOP. Figure 1: Sample/diversion bag Figure 2: Collecting a whole blood sample Figure 3: Sliding the NIP over the needle hub Figure 4: Withdrawing the needle into the NIP Post-Processing and Red Blood Cell Leukoreduction Required Supplies: • Leukoreduction rack • Tubing sealer 1. After processing, remove the plasma bag, the plasma cryoprecipitate reduced bag, the residual leukocyte bag, and the IPU bag from the organizer and handle them according to your institution's SOP. Note : You must rest and agitate the IPU prior to platelet pooling. For conditions for resting and agitating the IPU, see the platelet pooling set instructions for use. 2. Prepare a leukoreduction rack with a head height of at least 43½ in (110 cm). 3. Remove the RBC bag from the organizer. 4. Hang the RBC bag from the leukoreduction rack so that the filter hangs vertically. 5. Open blue clamp G. 6. Break CLIKTIP H. 7. Break CLIKTIP J. 8. Drain all of the additive solution through the filter and into the whole blood bag. 9. Close blue clamp G. 10. Gently mix the additive solution with the RBC unit in the whole blood bag. 11. Hang the whole blood bag on the leukoreduction rack. 12. Ensure that the tubing is free of kinks or other obstructions. 13. Open blue clamp G and allow the mixture of red blood cells and additive solution to flow through the leukoreduction filter. Do not squeeze the whole blood bag to increase the draining rate. Filtration is complete when the inlet side of the leukoreduction filter collapses and the red blood cells drain from the inlet side of the filter. 14. Seal the RBC tubing below the leukoreduction filter and disconnect the RBC bag. Ensure that the filter remains in a vertical position while you seal the tubing, as this prevents the loss of red blood cells. 15. Dispose of the whole blood bag and filter assembly safely according to your institution's SOP and/or local regulations. 16. Seal the line for sampling segments according to your institution's SOP. 17. Store the RBC product according to your institution's SOP. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Set Diagram Figure 1 Figure 2 Figure 3 Figure 4

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 )

12 CLINICAL PHARMACOLOGY 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.

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.

20230828

2

3 DOSAGE FORMS AND STRENGTHS 70 mL Citrate Phosphate Dextrose (CPD) anticoagulant is a sterile solution in a PVC plasticized with DEHP bag. Each 70 mL of CPD contains: Dextrose (anhydrous) 1.624 g, Trisodium Citrate (dihydrate) 1.841 g, Citric Acid (monohydrate) 0.229 g, Sodium Dihydrogen Phosphate (dihydrate) 0.176 g, and water for injection up to 70 mL. 111 mL Additive Solution 5 (AS-5) red cell preservative solution is a sterile solution in a PVC plasticized with DEHP bag. Each 111 mL of AS-5 contains: Dextrose (anhydrous) 0.908 g, Sodium Chloride 0.973 g, Mannitol 0.583 g, Adenine 0.035 g, and water for injection up to 111 mL. 70 mL Citrate Phosphate Dextrose (CPD) anticoagulant sterile fluid in a PVC plasticized with DEHP bag. ( 3 ) 111 mL Additive Solution 5 (AS-5) red cell preservative solution sterile fluid in a PVC plasticized with DEHP bag. ( 3 )

Reveos Select CPD/AS-5 Red Cell Preservative For Collection Of Blood Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, and Sodium Phosphate, Monobasic, Unspecified Form Dextrose Monohydrate Anhydrous Dextrose Trisodium Citrate Dihydrate ANHYDROUS CITRIC ACID Anhydrous Citric Acid ANHYDROUS CITRIC ACID Sodium Phosphate, Monobasic, Unspecified Form PHOSPHATE ION SODIUM CATION Water

BN880217

Reveos Select CPD/AS-5 Red Cell Preservative For Collection Of Blood

Dextrose Monohydrate, Trisodium Citrate Dihydrate, Anhydrous Citric Acid, and Sodium Phosphate, Monobasic, Unspecified Form

82906-506

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

PRINCIPAL DISPLAY PANEL - 70 mL Bag Pouch Case Label TERUMO Reveos ® SELECT CPD/AS-5 RED CELL PRESERVATIVE SOLUTION FOR COLLECTION OF 500mL OF BLOOD CAUTIONS: For single use only. Sterile fluid path, sterilized using steam. Non-pyrogenic fluid path. Do not re-sterilize. Read the instructions carefully before use. Do not use if package is damaged. Store between 1°C and 30°C Manufactured by : TERUMO BCT Vietnam Co., Ltd. Long Duc Industrial Park, Long Duc Commune, Long Thanh District, Dong Nai Province, Vietnam For : TERUMO BCT, Inc. 10811 W. Collins ave. Lakewood, CO 80215 Rx ONLY D0000036575-A XXXX LOT : LOT # MFG DATE : Date of Mfg. EXPIRY DATE : Exp. Date CAT. NO. : 6FO506A0 UNITS : 016 NDC : 82906-506-16 NDC (ISBT 128) PRINCIPAL DISPLAY PANEL - 70 mL Bag Pouch Case Label

Issued: February 2023 Manufactured by: TERUMO BCT Vietnam CO., Ltd. Long Duc Industrial Park, Long Duc Commune, Long Thanh District, Dong Nai Province, Vietnam For: Terumo BCT, Inc. 10811 W. Collins Ave. Lakewood, CO 80215

8 USE IN SPECIFIC POPULATIONS The Reveos SELECT set has not been adequately studied in controlled clinical trials with specific populations. The Reveos SELECT set has not been studied in controlled clinical trials with specific populations. ( 8 )

16 HOW SUPPLIED/STORAGE AND HANDLING The blood bag sets are packaged in outer aluminum foil pouches. Each outer aluminum foil pouch contains 2 blood bag sets. Each case contains 8 outer aluminum foil pouches. CATALOG NUMBER NDC NUMBER 6FO506A0 Carton: 82906-506-16 Aluminum foil: 82906-506-02 Primary Collect Bag: 82906-506-01 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. Once you open the transparent packing wrap, you must use the blood bag set within 7 days, not exceeding 28 days from when you opened the outer aluminum foil pouch. Each outer aluminum foil pouch contains sachets that absorb oxygen. Dispose of the sachets and the outer aluminum foil pouch with normal waste.

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. Once you open the transparent packing wrap, you must use the blood bag set within 7 days, not exceeding 28 days from when you opened the outer aluminum foil pouch. Each outer aluminum foil pouch contains sachets that absorb oxygen. Dispose of the sachets and the outer aluminum foil pouch with normal waste.