FDA.reportPublic FDA data

rejuvesol red blood cell processing solution

Manufacturer
Citra Labs, LLC | Grand River Aseptic Manufacturing Inc
Effective date
2023-02-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 20:47:16

Label at a glance#

ProductRejuvesol
Active ingredientSODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Label structure15 sections

Dosage and administration

NOTE: REJUVENATED RBC STORED IN ANY OTHER ANTICOAGULANT/ADDITIVE SOLUTION COMBINATION HAVE NOT BEEN APPROVED TO BE IMMEDIATELY WASHED AND TRANSFUSED. (As Suggested or Equivalent) An FDA cleared cell washer/washing system. Temperature-controlled (circulating) water bath (Blue-M MW-1140A, Helmer DH-4). Integral tubing sealer (Sebra 1100). Alcohol swabs (70%) (B-D 6894). One vial (50 mL) of rejuvesol ® Red Blood Cell...

Storage and handling

It is recommended that the product be stored at 15 - 25 °C (59 - 77 °F). Protect from freezing. Exposure to temperatures near or below freezing may produce a white precipitate in the solution; this precipitate will dissolve upon brief incubation at room temperature. Alternatively, the product may be warmed at 37 °C for up to one hour in a dry air incubator to dissolve the precipitate.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

For Use in the Extracorporeal Rejuvenation of Red Blood Cells

50 mL Glass Vial
NDC 23731-7000-5
PN 7012 12 Vials/Case

DESCRIPTION

DESCRIPTION SECTION

Rejuvesol ® Red Blood Cell Processing Solution ( rejuvesol ® Solution) is a sterile, non-pyrogenic solution of sodium pyruvate, inosine, adenine, dibasic sodium phosphate, and monobasic sodium phosphate in water for injection intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC). Each 50 mL of rejuvesol ® Solution contains sodium pyruvate 0.550 g, inosine 1.34 g, adenine 0.034 g, dibasic sodium phosphate (heptahydrate) 0.730 g, and monobasic sodium phosphate (monohydrate) 0.311 g, in water for injection, pH 6.7-7.4.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

A gradual depletion of red blood cell adenosine triphosphate (ATP) and 2,3 diphosphoglycerate (2,3-DPG) occurs with storage of RBC at 1-6 °C. 1 The level of 2,3-DPG in RBC stored for greater than 14 days is less than 10% of normal 1,2,12,17,18. Rejuvenation of RBC with rejuvesol ® Solution increases the levels of ATP and 2,3-DPG. 1-5,8,13,17-22,24, 25

An in vitro loss of red blood cells occurs with the preservation and processing of RBC. Thus, the effectiveness of a transfusion is influenced by both the total number of red blood cells transfused and the number of those cells which remain in circulation. Therefore, the "dose" of a transfusion is defined as the percentage of pre-transfusion recovered red blood cells multiplied by the 24 hour post-transfusion survival value.

Rejuvenation is accomplished by incubating the contents of one 50 mL vial of rejuvesol ® Solution with one unit of RBC (prepared from up to 550 mL of whole blood) for sixty (60) minutes at 37 °C. Citra recommends that the entire 50 mL of rejuvesol ® Solution be added to a "smaller than normal" RBC as long as the prerejuvenation net packed cell weight is greater than 110 grams. 1,9

INDICATION AND USAGE

INDICATIONS & USAGE SECTION

Rejuvesol ® Solution is intended only to be used as an in vitro processing solution for the rejuvenation of a unit of RBC. RBC may be rejuvenated after storage in CPD (non-leukocyte reduced), CPDA-1, (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), or CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced). The final concentration of ATP and 2,3-DPG achieved after rejuvenation will vary depending on the number of days of liquid storage at 1-6 °C prior to rejuvenation. NOTE: For simplicity, RBC stored in CPD (non-leukocyte reduced), CPDA-1 (non-leukocyte reduced), CPD/ADSOL ® (CPD/AS-1 leukocyte reduced), CP2D/Nutricel ® (CP2D/AS-3, leukocyte reduced) are referred to hereafter as CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3, respectively. Citra Labs, LLC, recommends that rejuvenation of RBC be performed after 14 days or longer of liquid storage. RBC (CPD, CPDA-1, CPD/AS-1, and CP2D/AS-3) rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal 5,6 (See Warning and Contraindications).

Rejuvenation of CPD or CPDA-1 RBC for Immediate use or for Cryopreservation

SPL UNCLASSIFIED SECTION

RBC which have been collected and stored in CPD or CPDA-1 anticoagulant may be rejuvenated up to three days after the expiration date of the RBC, as long as storage at 1-6 °C is not interrupted. 3,4 After rejuvenation, RBC (CPD and CPDA-1) must be either washed and stored at 1-6 °C for up to 24 hours prior to transfusion or glycerolized and frozen at –80 °C (below –65 °C). Red Blood Cells Frozen Rejuvenated which were collected and stored in CPD or CPDA-1 may be stored frozen up to 10 years. 10

When RBC are rejuvenated after maximum liquid storage, i.e., CPD RBC at 24 days or CPDA-1 RBC at 38 days, the concentrations of 2,3-DPG and ATP increase typically to above normal. 1,3-5,6

CAUTION: RBC collected in CPD or CPDA-1 cannot be leukocyte reduced prior to rejuvenation.

Rejuvenation of CPD/AS-1 RBC or CP2D/AS-3

SPL UNCLASSIFIED SECTION

Rejuvesol ® Solution has not been approved for the rejuvenation of RBC stored in any additive systems other than AS-1 or AS-3. RBC stored in CPD/AS-1 or CP2D/AS-3 at 1-6 °C may be rejuvenated up to, but not exceeding, 42 days of storage as long as storage at 1-6 °C is not interrupted. Rejuvenated CPD/AS-1 RBC must be either washed and stored at 1-6 °C for up to 24 hours prior to transfusion or glycerolized and frozen at –80 °C (below –65 °C). Red Blood Cells Frozen Rejuvenated which were collected and stored in CPD/AS-1 may be stored for up to 3 years. Rejuvenated CP2D/AS-3 RBC must be washed and stored at 1-6 °C for up to 24 hours prior to transfusion. Unlike rejuvenated CPD, CPDA-1, CPD/AS-1 RBC, and CP2D/AS-3, rejuvenated RBC collected and stored in any other anticoagulant/additive solution combination have not been approved to be immediately washed and transfused or for cryopreservation.

Rejuvenation of CPD/AS-1 RBC for Cryopreservation

SPL UNCLASSIFIED SECTION

When CPD/AS-1 RBC are rejuvenated at 42 days of liquid storage, frozen, deglycerolized, and stored for 24 hours, the concentration of 2,3-DPG and ATP increases to above normal. In a limited study, the average 24 hour post-transfusion survival value of these cells was statistically higher than the reported 12 survival value of CPD/AS-1 red blood cell concentrates which are stored for 42 days prior to transfusion. The "dose" may be equivalent for a CPD/AS-1 RBC whether the unit is stored for 42 days prior to transfusion or stored for 42 days, rejuvenated, frozen, deglycerolized, and stored for 24 hours prior to transfusion. Unlike rejuvenated CPD/AS-1 RBC, rejuvenated RBC (CP2D/AS-3) has not been approved for cryopreservation.

Rejuvenation of CPD/AS-1 RBC or CP2D/AS-3 for Immediate Use

SPL UNCLASSIFIED SECTION

When CPD/AS-1 RBC are rejuvenated at 42 days of liquid storage, washed, and stored for 24 hours, the concentration of ATP increases to day 0 values. For 2,3-DPG rejuvenation of RBCs stored in CPD/AS-1 for 42 days, the range of 2,3 DPG relative to day 0 value was 46%-172% with a mean of 98% ± 29%. For 66% of the RBC units (44/67, 33/33 in Site A and 11/34 in Site B) the concentration of 2,3-DPG reached at least 80% of the day 0 value.

When CP2D/AS-3 RBC are rejuvenated at 42 days of liquid storage, washed, and stored for 24 hours, the concentration of ATP increases to day 0 values. For 2,3-DPG rejuvenation of RBCs stored in CPD/AS-1 for 42 days, the range of 2,3 DPG relative to day 0 value was 48%-150% with a mean of 96% ± 23%. For 76% of the RBC units (52/68, 30/35 in Site A and 22/33 in Site B) the concentration of 2,3-DPG reached at least 80% of the day 0 value.

WARNING AND CONTRAINDICATIONS

WARNINGS SECTION

Rejuvesol ® Solution is intended only for the extracorporeal rejuvenation of a RBC. It should never be directly administered to Humans.

Rejuvesol ® Solution must not be added to whole blood because the additional plasma may reduce the effectiveness of the rejuvenation process. Immediately after rejuvenation, RBC must either be washed via an approved protocol prior to transfusion or glycerolized and frozen. RBC which have been rejuvenated, glycerolized, and frozen must be deglycerolized via an approved protocol prior to transfusion.

RBC rejuvenated before 6 days of storage may achieve 2,3-DPG levels in excess of 2 times normal and ATP levels in excess of 1.5 times normal. 5,6 In patients with reduced arterial blood p0 2 of less than 40 torr, the use of RBC rejuvenated before 6 days of storage are contraindicated because their high 2,3-DPG levels and low oxygen affinity may impair proper oxygenation of the red blood cells in the lung. 7

Rejuvenated RBC are further processed prior to transfusion to remove the un-used portion of rejuvesol ® Solution, by-products of the rejuvenation process, and any other potential storage-related impurities in rejuvesol ® Solution. Based on the concentration of the residual inosine in rejuvenated RBC that are either washed or deglycerolized, the average washout of inosine was calculated to be > 97.4%. A literature search for potential toxicity associated with the ingredients that comprise rejuvesol ® Solution, including potential metabolites, was conducted. 23 This report concludes that no theoretical contraindications would be associated with the transfusion of a single unit of unwashed, rejuvenated RBC that would contain amounts of pyruvate, inosine, adenine, phosphate, hypoxanthine, uric acid, and lactate that exceed reference values (excluding lactate) as these substances are naturally metabolized and/or are excreted. 23

The maximum number of properly processed rejuvenated RBC that can be transfused to a single recipient over their entire lifetime has not been determined.

PRECAUTIONS

PRECAUTIONS SECTION

  • Aseptic technique must be maintained at all times.
  • Do not use unless solution is clear/colorless and seal is intact. Product that exhibits a slight yellow color should not be used. Product instability has been observed after continuous exposure at high temperature (after 6 months at 40 °C and after 9 months at >30 °C).
  • This product contains no bacteriostatic or antimicrobial agents and is intended for single use only.
  • Rx Only - Federal (USA) law prohibits dispensing without prescription.

STORAGE

STORAGE AND HANDLING SECTION

It is recommended that the product be stored at 15 - 25 °C (59 - 77 °F). Protect from freezing. Exposure to temperatures near or below freezing may produce a white precipitate in the solution; this precipitate will dissolve upon brief incubation at room temperature. Alternatively, the product may be warmed at 37 °C for up to one hour in a dry air incubator to dissolve the precipitate.

HOW SUPPLIED

HOW SUPPLIED SECTION

PN 7012: 50 mL vial; 12 vials per case

DIRECTIONS FOR REJUVENATION OF CPD, CPDA-1, CPD/AS-1, OR CP2D/AS-3 RBC PRIOR TO IMMEDIATE USE 3,11,25

INSTRUCTIONS FOR USE SECTION

NOTE: REJUVENATED RBC STORED IN ANY OTHER ANTICOAGULANT/ADDITIVE SOLUTION COMBINATION HAVE NOT BEEN APPROVED TO BE IMMEDIATELY WASHED AND TRANSFUSED.

MATERIALS AND EQUIPMENT

SPL UNCLASSIFIED SECTION

(As Suggested or Equivalent)

  1. An FDA cleared cell washer/washing system.
  2. Temperature-controlled (circulating) water bath (Blue-M MW-1140A, Helmer DH-4).
  3. Integral tubing sealer (Sebra 1100).
  4. Alcohol swabs (70%) (B-D 6894).
  5. One vial (50 mL) of rejuvesol ® Red Blood Cell Processing Solution, rejuvesol ® Solution (Citra PN 7012)
  6. Y-type Rejuvenation Set for the addition of rejuvesol ® Solution (Citra PN 7212) or equivalent.
  7. Two watertight plastic overwrap bags (Kapak, Scotchpack, 404).
  8. Waterproof tape (3M R202).
  9. Overwrap bag impulse sealer (Stericon 210X).

PROCEDURE

SPL UNCLASSIFIED SECTION

I. TO COMBINE rejuvesol ® Solution WITH THE RBC

SPL UNCLASSIFIED SECTION

  1. Remove the flip-off protective cap from the rejuvesol ® Solution vial and swab the exposed rubber stopper surface with an alcohol swab.
  2. Close all slide clamps of the Y-type Rejuvenation Set (Citra PN 7212). Heat seal the integral tubing between the 300 mL transfer bag and the Y connector, detach and discard the empty transfer bag.
  3. Aseptically, insert the vented spike of the Y-type Rejuvenation Set into the stopper of the vial of rejuvesol ® Solution.
  4. Join the tubing of the Y-type Rejuvenation Set to the integral tubing of the primary collection bag using a sterile docking device. Alternately, aseptically insert the bag spike of the Y-type Rejuvenation Set into one of the administration ports of the primary collection bag.
  5. Elevate the rejuvesol ® Solution vial approximately 28 inches above the primary collection bag.
  6. Squeeze the drip chamber to prime the system and open the slide clamp of the Y-type Rejuvenation Set.
  7. Allow the entire contents of the rejuvesol ® Solution vial to flow into the primary collection bag while gently agitating the mixture. This typically takes between 15 and 30 seconds.
  8. After all the rejuvesol ® Solution has been transferred, close the slide clamp and heat seal the tubing three times between the portion of the Y-type Rejuvenation Set that connects the rejuvesol ® Solution vial to the primary collection bag.
  9. Cut the middle heat seal and discard the used tubing and empty rejuvesol ® Solution vial.
  10. Proceed immediately to Section II.
II. TO INCUBATE THE RED BLOOD CELL/ rejuvesol ® Solution MIXTURE FOR 60 MINUTES AT 37 °C 3,11,25

SPL UNCLASSIFIED SECTION

NOTE: The timing of incubation is measured from the time the red blood cell/ rejuvesol ® Solution mixture is introduced into the water bath. The actual temperature of the red blood cell/ rejuvesol ® Solution mixture does not reach 37 °C (the final temperature is usually 29-31 °C).

  1. Place the primary collection bag containing the red blood cell/ rejuvesol ® Solution mixture into a plastic overwrap bag and flatten the overwrap bag to remove all air prior to sealing
  2. Seal the plastic overwrap bag with tape or heat seal.
  3. Place the sealed overwrapped unit inside a second overwrap bag containing lead weights (to keep the unit submerged during incubation); flatten and seal.
  4. Place the overwrapped unit in the water bath and secure the overwrapped unit to the inside wall of the water bath with waterproof tape.
  5. Incubate the overwrapped unit in a 37 °C water bath for 60 minutes with agitation.
  6. Remove the overwrapped bag from the water bath, dry the outer overwrap bag with clean, disposable toweling and carefully remove the plastic overwraps from the red blood cell/ rejuvesol ® Solution mixture assuring that the primary collection bag and mixture are not contaminated with any water from the water bath.
III. TO PROCESS THE RED BLOOD CELL/rejuvesol ® Solution MIXTURE AFTER INCUBATION 3,11

SPL UNCLASSIFIED SECTION

Remove the excess rejuvesol ® Solution after rejuvenation by use of an approved cell washing system and standard operating procedures for that system. 3 The rejuvenated, washed RBC may be stored at 1-6 °C for up to 24 hours prior to transfusion. 3,10,11

NOTES:

  • No more than four (4) hours should elapse between the time the unit is removed from the refrigerator and the time the cells are placed in the refrigerator. 11
  • Rejuvenated-washed RBC not intended for immediate use should be resuspended in 0.9% Sodium Chloride, 0.2% Dextrose for storage at 1-6 °C. Then, just prior to use, to ensure <1% hemolysis in the final product, concentrate the RBC according to local SOP proven to achieve a hematocrit of approximately 80%. 9,24

DIRECTIONS FOR REJUVENATION OF CPD OR CPDA-1 RBC PRIOR TO CRYOPRESERVATION IN AN 800 ML PRIMARY COLLECTION BAG

INSTRUCTIONS FOR USE SECTION

NOTE: One 50 mL vial of rejuvesol ® Solution can be used to rejuvenate one unit of RBC derived from 450 mL, or the volume as stated in the package insert for the 800 mL primary collection bag, of whole blood when collected in an 800 mL primary collection bag.

MATERIALS AND EQUIPMENT

SPL UNCLASSIFIED SECTION

(As Suggested or Equivalent)

  1. Temperature-controlled (circulating) water bath (Blue-M MW-1140A, Helmer DH-4).
  2. Integral tubing sealer (Sebra 1100).
  3. Alcohol swabs (70%) (B-D 6894).
  4. One vial (50 mL) of rejuvesol Red Blood Cell Processing Solution, rejuvesol ® Solution (Citra PN 7012).
  5. Tubing set for the addition of rejuvesol ® Solution and glycerol solution - Rejuvenation Harness 28" (71 cm), MedSep, Corp. Code #980-52 or Y-type transfer set, Baxter International #4C1921 or equivalent.
  6. Two watertight plastic overwrap bags (Kapak, Scotchpack, 404).
  7. Waterproof tape (3M R202).
  8. Overwrap bag impulse sealer (Stericon 210X).
  9. Filtered airway needle (BD 5200) (Used only with Baxter International #4C1921).

PROCEDURE

SPL UNCLASSIFIED SECTION

I. TO COMBINE rejuvesol ® Solution WITH THE RBC 7

SPL UNCLASSIFIED SECTION

  1. Remove the flip-off protective cap from the rejuvesol ® Solution vial and swab the exposed rubber stopper surface with an alcohol swab.
  2. Close all clamps.
  3. Aseptically insert the appropriate spike or needle of the tubing set through the rubber stopper of the vial of rejuvesol ® Solution.
  4. Aseptically insert the bag spike of the tubing set into the adaptor port on the integral tubing of the primary collection bag.
  5. Elevate the rejuvesol ® Solution vial 28 inches above the primary collection bag.
  6. If a drip chamber is on the tubing set, squeeze the drip chamber to prime the system and open the clamp of the tubing set. If there is no drip chamber on the tubing set, open the clamp and aseptically insert a filtered airway needle through the rubber stopper of the vial of rejuvesol ® Solution.
  7. Allow the entire contents of the rejuvesol ® Solution to flow into the primary collection bag while gently agitating the mixture. This typically takes between 15 and 30 seconds.
  8. After all of the rejuvesol ® Solution has been transferred, close the clamp and heat seal the tubing three times between the portion of the tubing set that connects the rejuvesol ® Solution vial to the Y-connector so that the unused vented spike remains attached to the adaptor port.
  9. Cut the middle heat seal and discard the used tubing and empty rejuvesol ® Solution vial.
  10. Proceed immediately to Section II.
II. TO INCUBATE THE RED BLOOD CELL/rejuvesol ® Solution MIXTURE FOR 60 MINUTES AT 37 °C 1,7,10,11

SPL UNCLASSIFIED SECTION

NOTE: The timing of the incubation is measured from the time the red blood cell/ rejuvesol ® Solution mixture is introduced into the water bath. The actual temperature of the red blood cell/ rejuvesol ® Solution mixture does not reach 37 °C (the final temperature is usually 29-31 °C).

  1. Place the primary collection bag containing the red blood cell/ rejuvesol ® Solution mixture into a plastic overwrap bag with the unused portion of the Rejuvenation Harness or Y-type Transfer Set and flatten the overwrap to remove all air prior to sealing.
  2. Seal the plastic bag with tape or heat seal.
  3. Place the sealed overwrapped unit inside a second overwrap bag containing lead weights (to keep the unit submerged during incubation); flatten and seal.
  4. Place the overwrapped unit in the water bath. Secure the overwrap bag to the inside wall of the water bath with waterproof tape.
  5. Incubate the unit in a 37 °C water bath for 60 minutes.
  6. Remove the overwrapped unit from the water bath; dry the outer overwrap bag with clean, disposable toweling and carefully remove the plastic overwraps from the red blood cell/ rejuvesol ® Solution mixture assuring that the primary collection bag and mixture are not contaminated with any water from the water bath.

NOTE: Centrifugation after rejuvenation is not required for RBC intended to be frozen in the 800 mL Primary Collection Bag. Glycerolized RBC are centrifuged prior to freezing.

III. TO PROCESS THE RED BLOOD CELL/rejuvesol ® Solution MIXTURE AFTER INCUBATION 7

SPL UNCLASSIFIED SECTION

  1. After the 60 minute incubation at 37 °C, the red blood cell/ rejuvesol ® Solution mixture is ready for immediate glycerolization.
  2. Complete the glycerolization per Standard Operating Procedure. 7

NOTES:

  • Rejuvenated-glycerolized RBC to be frozen in the 800 mL primary collection bag must be concentrated to achieve a hematocrit of approximately 60 ± 5 % after glycerolization per Standard Operating Procedure. 7
  • No more than four (4) hours should elapse between the time the unit is removed from the refrigerator and the time the cells are placed in the freezer. 11
  • Rejuvenated-deglycerolized RBC not intended for immediate use should be resuspended in 0.9% Sodium Chloride, 0.2% Dextrose for storage at 1-6 °C. Then, just prior to use, to ensure < 1% hemolysis in the final product, concentrate the RBC following local SOP proven to achieve a hematocrit of approximately 85%. 7,9,24

DIRECTIONS FOR REJUVENATION OF CPD, CPDA-1, OR CPD/AS-1 RBC PRIOR TO CRYOPRESERVATION

INSTRUCTIONS FOR USE SECTION

NOTE: REJUVENATED RBC STORED IN ANY OTHER ANTICOAGULANT/ADDITIVE SOLUTION COMBINATION HAVE NOT BEEN APPROVED FOR CRYOPRESERVATION.

MATERIALS AND EQUIPMENT

SPL UNCLASSIFIED SECTION

(As Suggested or Equivalent)

  1. Temperature-controlled (circulating) water bath (Blue-M MW-1140A, Helmer DH-4).
  2. Integral tubing sealer (Sebra 1100)
  3. Alcohol swabs (70%) (B-D 6894).
  4. One vial (50 mL) of rejuvesol ® Red Blood Cell Processing Solution, rejuvesol ® Solution (Citra PN 7012).
  5. Y-type Rejuvenation Set for the addition of rejuvesol ® Solution (Citra PN 7212) or equivalent.
  6. Two watertight plastic overwrap bags (Kapak, Scotchpack, 404).
  7. Waterproof tape (3M R202).
  8. Overwrap bag impulse sealer (Stericon 210X).

PROCEDURE

SPL UNCLASSIFIED SECTION

I. TO COMBINE rejuvesol ® Solution WITH THE RBC

SPL UNCLASSIFIED SECTION

  1. Remove the flip-off protective cap from the rejuvesol ® Solution vial and swab the exposed rubber stopper surface with an alcohol swab.
  2. Close all slide clamps of the Y-type Rejuvenation Set (Citra PN 7212).
  3. Aseptically, insert the vented spike of the Y-type Rejuvenation Set into the stopper of the vial of rejuvesol ® Solution.
  4. Join the tubing of the Y-type Rejuvenation Set to the integral tubing of the primary collection bag using a sterile docking device. Alternately, aseptically insert the bag spike of the Y-type Rejuvenation Set into one of the administration ports of the primary collection bag.
  5. Elevate the rejuvesol ® Solution vial approximately 28 inches above the primary collection bag.
  6. Squeeze the drip chamber to prime the system and open the slide clamp of the Y-type Rejuvenation Set.
  7. Allow the entire contents of the rejuvesol ® Solution vial to flow into the primary bag while gently agitating the mixture. This typically takes between 15 and 30 seconds.
  8. After all of the rejuvesol ® Solution has been transferred, close the slide clamp and heat seal the tubing three times between the portion of the Y-type Rejuvenation Set that connects the rejuvesol ® Solution vial to the primary collection bag.
  9. Cut the middle heat seal and discard the used tubing and empty rejuvesol ® Solution vial.
  10. Proceed immediately to Section II.
II. TO INCUBATE THE RED BLOOD CELL/rejuvesol ® Solution MIXTURE FOR 60 MINUTES AT 37 °C 1,8,9,11,13

SPL UNCLASSIFIED SECTION

NOTE: The timing of the incubation is measured from the time the red blood cell/ rejuvesol ® Solution mixture is introduced into the water bath. The actual temperature of the red blood cell/ rejuvesol ® Solution mixture does not reach 37 °C (the final temperature is usually 29-31 °C).

  1. Place the primary collection bag containing the red blood cell/ rejuvesol ® Solution mixture with the attached transfer bag of the Y-type Rejuvenation Set in a plastic overwrap bag and flatten the overwrap to remove all air prior to sealing.
  2. Seal the plastic overwrap with tape or heat seal.
  3. Place the sealed overwrapped unit inside a second overwrap bag containing lead weights (to keep the unit submerged during incubation); flatten and seal.
  4. Place the overwrapped unit in the water bath and secure the overwrap to the inside wall of the water bath with waterproof tape.
  5. Incubate the unit in a 37 °C water bath for 60 minutes with agitation.
  6. Remove the overwrapped unit from the water bath; dry the outer overwrap with clean, disposable toweling and carefully remove the overwraps from the red blood cell/ rejuvesol ® Solution mixture assuring that the primary collection bag and mixture are not contaminated with any water from the water bath.
III. TO PROCESS THE RED BLOOD CELL/rejuvesol ® Solution MIXTURE AFTER INCUBATION 1,9,11,13

SPL UNCLASSIFIED SECTION

Complete the glycerolization procedure per Standard Operating Procedure. 1,10,11

NOTES:

  • After incubation, the red blood cell/ rejuvesol ® Solution mixture may need to be concentrated prior to the addition of glycerol solution to insure proper glycerolization. 1,9,11,13
  • No more than four (4) hours should elapse between the time the unit is removed from the refrigerator and the time the cells are placed in the freezer. 11

REFERENCES

REFERENCES SECTION

  1. Valeri CR, CG Zaroulis, Rejuvenation and Freezing of Outdated Stored Human Red Blood Cells; NEJMED 1972;287:1307-1313.
  2. Valeri CR. Unpublished Data.
  3. Valeri CR, AD Gray, GP Cassidy, et al.; The 24-hour posttransfusion survival, oxygen transport function, and residual hemolysis of human outdated-rejuvenated red cell concentrates after washing and storage at 4 °C for 24 to 72 hours. Transfusion 1984; 24:323-6.
  4. Valeri CR, CG Zaroulis, JJ Vecchione, et al.; Therapeutic effectiveness and safety of outdated human red blood cells rejuvenated to restore oxygen transport function to normal, frozen for 3 to 4 years at –80 °C, washed, and stored at 4 °C for 24 hours prior to rapid infusion. Transfusion 1980; 20:159-70.
  5. Valeri, CR, DA Valeri, JJ Vecchione, and CP Emerson; Biochemical modification and freeze preservation of red blood cells, Critical Care Med. 7 (9):439-477, 1979.
  6. Valeri CR; Status report on rejuvenation and freezing of red blood cells. Plasma Therapy 2 (3): 155-170, 1981.
  7. Boston University School of Medicine/Naval Blood Research Laboratory, Boston, MA Standard Operating Procedure—Red Blood Cells Collected in the CPDA-1 800 mL Primary PVC Plastic Collection Bag System and Stored for 3 to 35 Days (Indated-Rejuvenated) or for 36 to 38 Days (Outdated-Rejuvenated), Biochemically Modified with PIPA Solution Prior to Glycerolization in the Primary 800 mL Bag with the Special Adaptor Port Using 40% W/V Glycerol and Storage at –80 °C, Washed in the Haemonetics Blood Processor 115, and Stored at 4 °C for 24 Hours Prior to Transfusion (Revised 5/91).
  8. Whitely, PH, et al; Improved recovery of ATP and 2,3-DPG with agitation during incubation at 37 °C in rejuvesol ® Solution treated CPD/AS-1 RBC. Transfusion 53 (supp), SP81, 2013.
  9. Valeri CR; Simplification of the Methods for Adding and Removing Glycerol During Freeze-Preservation of Human Red Blood Cells with the High or Low Glycerol Methods: Biochemical Modification Prior to Freezing . Transfusion 15(3): 195-218, 1975.
  10. AABB Standards for Blood Banks and Transfusion Services, 27th Edition.
  11. American Association of Blood Banks Technical Manual, pages 946-953, 17th Edition, 2011.
  12. Valeri CR, LE Pivacek, M Palter, RC Dennis, N Yeston, CP Emerson, and MD Altschule; A clinical experience with ADSOL ® preserved erythrocytes. Surgery, Gynecology, and Obstetrics 166:33-46, 1988.
  13. Szymanski IO, Teno RA, Lockwood WB, Hudgens, R, and Johnson, GS; Effect of rejuvenation and frozen storage on 42-day-old AS-1 RBCs. Transfusion 41: 550-555, 2001.
  14. Gelderman MP and Vostal JG; Rejuvenation Improves Roller Pump-Induces Stress resistance of Fresh and Stored Red Blood Cells. Transfusion 51:1096-1104, 2011.
  15. Meyer EK, et al; Rejuvenation Capacity of Red Blood Cells in Additive Solutions Over Long-Term Storage. Transfusion, 51(7):1574-1579, 2011.
  16. Koshkaryev A, et al; Rejuvenation Treatment of Stored Red Blood Cells Reverses Storage-Induced Adhesion to Vascular Endothelial Cells. Transfusion, 49:2136-2143, 2009.
  17. Dennis RC, et al; Transfusion of 2,3-DPG-Enriched Red Blood Cells to Improve Cardiac Function. Ann. Thor. Surg., 26:16-17, 1978.
  18. Valeri CR, et al; Improved Oxygen Delivery to the Myocardium During Hypothermia by Perfusion with 2,3-DPG Enriched Red Blood Cells. Ann. Thorac. Surg., 30(6): 527-535, 1980.
  19. Valeri CR, et al; Human Red Blood Cells with Normal or Improved Oxygen Transport Function Prepared and Frozen in the Primary Polyvinyl Chloride Plastic Blood Collection Container. Transfusion and Immunohaematology, 22:467-486, 1979.
  20. Ragno G and Valeri, CR, Salvaging of Liquid-Preserved O-Positive and O-Negative Red Blood Cells by Rejuvenation and Freezing. Transfus. Apher. Sci., 35(2): 137-143, 2006.
  21. Valeri CR, et al; Automation of the Glycerolization of Red Blood Cells with the High-Separation Bowl in the Haemonetics ACP 215 Instrument. Transfusion 45: 1621-1627, 2005
  22. Lockwood WB, et al; Effects of Rejuvenation and Frozen Storage on 42-Day-Old AS-3 RBCs. Transfusion 43(11): 1527-153, 2003.
  23. Loeb, WF, V.M.D, Ph.D; A Literature Review to Investigate the Feasibility of Modifying the Current Protocol for Use and Developing New Applications. unpublished communication, 19 Oct 2000.
  24. Valeri CR, et al; The Survival, Function, and Hemolysis of Human RBCs Stored at 4 °C in Additive Solution (AS-1, AS-3, and AS-5) for 42 Days and then Biochemically Modified, Frozen, Thawed, Washed, and Stored at 4 °C in Sodium Chloride and Glucose for 24 Hours. Transfusion 40: 1341-1345, 2000.
  25. Whitely, PH, et al; Improved ATP and 2,3-DPG recovery using the Sahara III dry-air blood warmer in CPD/AS-1 RBC treated with rejuvesol ® Solution. Transfusion 54 (supp), SP69, 2014.
  26. Whitely PH, et al; Restoration of morphology following rejuvenation of stored red blood cells (RBC), Transfusion 55 (supp 3), 74A-75A, 2015.
  27. Gray AD, et al; Extended Storage (>24 Hours) of Rejuvenated and Washed RBC, Transfusion 55 (supp 3), 68A-69A, 2015.

SPL UNCLASSIFIED SECTION

Rejuvesol® Solution is a registered trademark of Citra Labs, LLC, A Biomet Inc. Company.

ADSOL® is a registered trademark of Fenwal, Inc.

Nutricel® is a registered trademark of Haemonetics, Corp

Manufactured for: Citra Labs, LLC
55 Messina Drive, Braintree, MA 02184 ● USA
1-800-299-3411 ● Fax 781-848-6781
Manufactured by: Grand River Aseptic Manufacturing, Inc.
140 Front Ave SW, Suite 3 Grand Rapids, MI 49504 USA

©2013 CitraLabs
12/15

FL7000
Printed in USA

PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rejuvesol
red blood cell processing solution

STERILE
15°C - 25°C

Not for direct
administration to patients.
To be used only for
extracorporeal processing
of red blood cells.

PN 7012 50 mL

CitraLabs
A Biomet Inc. Company.

LA7012
02/15

Manufactured for: Citra Labs, LLC.
55 Messina Drive ● Braintree, MA 02184 ● USA
1-800-299-3411 ● Fax 781-848-6781
Manufactured by: Grand River Aseptic Manufacturing, Inc.
140 Front Ave. SW, Suite 3 ● Grand Rapids, MI 49504 ● USA

PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
PRINCIPAL DISPLAY PANEL - 50 mL Vial Label

PRINCIPAL DISPLAY PANEL - 50 mL Vial Case Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

rejuvesol
red blood cell processing solution

PN 7012 - 50 mL Vial Qty: 12

CitraLabs
A Biomet Inc. Company.

Fragile: Handle with care.
Protect from freezing
Store Between 15°C - 25°C (59°F - 77°F)

Manufactured for:
Citra Labs, LLC
55 Messina Drive
Braintree, MA 02184
Phone: 1-800-299-3411
Fax: 781-848-6781

Manufactured by:
Grand River Aseptic Manufacturing, Inc.
140 Front Ave SW Suite 3
Grand Rapids, MI 49504, USA

STERILE
15°C - 25°C

LA7012B
02/15

LOT X-XX-XXXX
EXP DATE YYYY/MM

PRINCIPAL DISPLAY PANEL - 50 mL Vial Case Label
PRINCIPAL DISPLAY PANEL - 50 mL Vial Case Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23731-7000-52023-02-14C16284748780-1f386c64a-0be2-0266-e053-dadaa90a7c1arejuvesol red blood cell processing solution
23731-7000-52023-01-30C16284748780-1f386c64a-0be2-0266-e053-dadaa90a7c1arejuvesol red blood cell processing solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23731-7000-5Rejuvesol50 mL in 1 VIAL, SINGLE-USESOLUTION507
23731-7000-5Rejuvesol12 in 1 CASESOLUTION127

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23731-7000REJUVESOL (SODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) SOLUTION [CITRA LABS, LLC]7Current NDC, Legacy NDC, 2 package rows20230215_bc06c40f-81a0-45e5-80b6-61f67d445068.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AdenineACTIVE INGREDIENTJAC85A21612
InosineACTIVE INGREDIENT5A614L51CT2
Sodium Phosphate, DibasicACTIVE INGREDIENTGR686LBA742
Sodium Phosphate, Monobasic, MonohydrateACTIVE INGREDIENT593YOG76RN2
Sodium PyruvateACTIVE INGREDIENTPOD38AIF082
AdenineACTIVE MOIETYJAC85A21612
InosineACTIVE MOIETY5A614L51CT2
Pyruvic AcidACTIVE MOIETY8558G7RUTR2
Sodium CationACTIVE MOIETYLYR4M0NH372

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
23731-700023731-7000-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PYRUVATEPOD38AIF08ACTIB
INOSINE5A614L51CTACTIB
ADENINEJAC85A2161ACTIB
SODIUM PHOSPHATE, DIBASICGR686LBA74ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RejuvesolSODIUM PYRUVATE, INOSINE, ADENINE, SODIUM PHOSPHATE, DIBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATECitra Labs, LLCbc06c40f-81a0-45e5-80b6-61f67d4450682023-02-14WarningsExact identifier
ndc (package): 23731-7000-5
ndc (product): 23731-7000
ndc11 (package): 23731700005
spl id: f07bc3c3-29f0-4f71-9696-47a1c2ec5bf2
spl set id: bc06c40f-81a0-45e5-80b6-61f67d445068

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.