Rejuvesol
Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, And Sodium Phosphate, Monobasic, Monohydrate
Citra Labs, Llc
Human Prescription Drug
NDC 23731-7000Rejuvesol also known as Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, And Sodium Phosphate, Monobasic, Monohydrate is a human prescription drug labeled by 'Citra Labs, Llc'. National Drug Code (NDC) number for Rejuvesol is 23731-7000. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Rejuvesol drug includes Adenine - .034 g/50mL Inosine - 1.34 g/50mL Sodium Phosphate, Dibasic - .73 g/50mL Sodium Phosphate, Monobasic, Monohydrate - .311 g/50mL Sodium Pyruvate - .55 g/50mL . The currest status of Rejuvesol drug is Active.
Drug Information:
| Drug NDC: | 23731-7000 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Rejuvesol |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Sodium Pyruvate, Inosine, Adenine, Sodium Phosphate, Dibasic, And Sodium Phosphate, Monobasic, Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Citra Labs, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ADENINE - .034 g/50mL INOSINE - 1.34 g/50mL SODIUM PHOSPHATE, DIBASIC - .73 g/50mL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - .311 g/50mL SODIUM PYRUVATE - .55 g/50mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | EXTRACORPOREAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 26 Feb, 1997 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | BN950522 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Citra Labs, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | JAC85A2161 5A614L51CT GR686LBA74 593YOG76RN POD38AIF08
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 23731-7000-5 | 12 VIAL, SINGLE-USE in 1 CASE (23731-7000-5) / 50 mL in 1 VIAL, SINGLE-USE | 26 Feb, 1997 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Rejuvesol sodium pyruvate, inosine, adenine, sodium phosphate, dibasic, and sodium phosphate, monobasic, monohydrate sodium pyruvate pyruvic acid inosine inosine adenine adenine sodium phosphate, dibasic phosphate ion sodium cation sodium phosphate, monobasic, monohydrate phosphate ion sodium cation
Indications and Usage:
Indication and usage 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 lev
Read more...els 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 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 â80 °c (below â65 °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 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 â80 °c (below â65 °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 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 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.
Warnings:
Warning and contraindications 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
Read more... 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.
Description:
Description 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 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
Read more... 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
How Supplied:
How supplied pn 7012: 50 ml vial; 12 vials per case
Package Label Principal Display Panel:
Principal display panel - 50 ml vial label 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 a biomet inc. company. la7012 02/15 manufactured for: citra labs, llc. 55 messina drive â braintree, ma 02184 â usa 1-800-299-3411 â fax 781-848-6781 manufactured by: grand river aseptic manufacturing, inc. 140 front ave. sw, suite 3 â grand rapids, mi 49504 â usa principal display panel - 50 ml vial label
Principal display panel - 50 ml vial case label rejuvesol red blood cell processing solution pn 7012 - 50 ml vial qty: 12 citra labs 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