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rejuvesol red blood cell processing solution | Rejuvesol [Citra Labs LLC] | BioPortfolio

13:15 EST 27th January 2019 | BioPortfolio

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For Use in the Extracorporeal Rejuvenation of Red Blood Cells

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

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.

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. The level of 2,3-DPG in RBC stored for greater than 14 days is less than 10% of normal . Rejuvenation of RBC with rejuvesol Solution increases the levels of ATP and 2,3-DPG.

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.

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 (See Warning and Contraindications).

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. 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.

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.

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

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.

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 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.

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.

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. In patients with reduced arterial blood p0 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.

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. 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.

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

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.

PN 7012: 50 mL vial; 12 vials per case

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)

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).

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

NOTES:

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.

(As Suggested or Equivalent)

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).

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.

NOTES:

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

(As Suggested or Equivalent)

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).

Complete the glycerolization procedure per Standard Operating Procedure.

NOTES:

Rejuvesol Solution is a registered trademark of Citra Labs, LLC, a Biomet Biologics 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

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

Citra Labs

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

rejuvesol red blood cell processing solution

PN 7012 - 50 mL Vial Qty: 12

Citra Labs A Biomet Biologics 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 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

Manufacturer

Citra Labs LLC

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Clinical Trials [1 Associated Clinical Trials listed on BioPortfolio]

Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the org...

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