Label: REJUVESOL- sodium pyruvate, inosine, adenine, sodium phosphate, dibasic, and sodium phosphate, monobasic, monohydrate so...view full title
- NDC Code(s): 23731-7000-5
- Packager: Citra Labs, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated February 14, 2023
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SPL UNCLASSIFIED SECTIONFor Use in the Extracorporeal Rejuvenation of Red Blood Cells - 50 mL Glass Vial - NDC 23731-7000-5 - PN 7012 12 Vials/Case
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DESCRIPTIONRejuvesol - ® Red Blood Cell Processing Solution ( rejuvesol - ® Solution) is a sterile, non-pyrogenic solution of sodium pyruvate, inosine, adenine, dibasic ...
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CLINICAL PHARMACOLOGYA 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 ...
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INDICATION AND USAGERejuvesol - ® 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 ...
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WARNING AND CONTRAINDICATIONSRejuvesol - ® Solution is intended only for the extracorporeal rejuvenation of a RBC. It should never be directly administered to Humans. Rejuvesol - ...
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PRECAUTIONSAseptic 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 ...
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STORAGEIt 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 ...
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HOW SUPPLIEDPN 7012: 50 mL vial; 12 vials per case
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DIRECTIONS FOR REJUVENATION OF CPD, CPDA-1, CPD/AS-1, OR CP2D/AS-3 RBC PRIOR TO IMMEDIATE USE
3,11,25
NOTE: REJUVENATED RBC STORED IN ANY OTHER ANTICOAGULANT/ADDITIVE SOLUTION COMBINATION HAVE NOT BEEN APPROVED TO BE IMMEDIATELY WASHED AND TRANSFUSED. MATERIALS AND EQUIPMENT - (As ...
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DIRECTIONS FOR REJUVENATION OF CPD OR CPDA-1 RBC PRIOR TO CRYOPRESERVATION IN AN 800 ML PRIMARY COLLECTION BAGNOTE: 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 ...
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DIRECTIONS FOR REJUVENATION OF CPD, CPDA-1, OR CPD/AS-1 RBC PRIOR TO CRYOPRESERVATIONNOTE: REJUVENATED RBC STORED IN ANY OTHER ANTICOAGULANT/ADDITIVE SOLUTION COMBINATION HAVE NOT BEEN APPROVED FOR CRYOPRESERVATION. MATERIALS AND EQUIPMENT - (As Suggested or ...
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REFERENCESValeri CR, CG Zaroulis, Rejuvenation and Freezing of Outdated Stored Human Red Blood Cells; NEJMED 1972;287:1307-1313. Valeri CR. Unpublished Data. Valeri CR, AD ...
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SPL UNCLASSIFIED SECTIONRejuvesol® 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 ...
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PRINCIPAL DISPLAY PANEL - 50 mL Vial Labelrejuvesol - red blood cell processing solution - STERILE - 15°C - 25°C - Not for direct - administration to patients ...
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PRINCIPAL DISPLAY PANEL - 50 mL Vial Case Labelrejuvesol - red blood cell processing solution - PN 7012 - 50 mL Vial Qty: 12 - CitraLabs - A Biomet Inc. Company. Fragile: Handle with ...
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INGREDIENTS AND APPEARANCEProduct Information