Jeanatope
Iodinated I-125 Albumin
Iso-tex Diagnostics, Inc.
Human Prescription Drug
NDC 50914-7733Jeanatope also known as Iodinated I-125 Albumin is a human prescription drug labeled by 'Iso-tex Diagnostics, Inc.'. National Drug Code (NDC) number for Jeanatope is 50914-7733. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Jeanatope drug includes Human Serum Albumin I-125 - 1000 uCi/mL . The currest status of Jeanatope drug is Active.
Drug Information:
| Drug NDC: | 50914-7733 |
| 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: | Jeanatope |
| 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: | Iodinated I-125 Albumin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Iso-tex Diagnostics, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, 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: | HUMAN SERUM ALBUMIN I-125 - 1000 uCi/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| 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: | BLA |
| 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: | 09 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 Jan, 2026 |
| 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: | BLA017836 |
| 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, 2023 |
| 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: | Iso-Tex Diagnostics, Inc.
|
| 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: | 68WQQ3N9TI
|
| 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. |
| Pharmacologic Class: | Radioactive Diagnostic Agent [EPC]
Radiopharmaceutical Activity [MoA]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50914-7733-5 | 1 VIAL, MULTI-DOSE in 1 CONTAINER (50914-7733-5) / 10 mL in 1 VIAL, MULTI-DOSE | 09 Mar, 2022 | 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:
Jeanatope iodinated i-125 albumin human serum albumin i-125 human serum albumin i-125 albumin human benzyl alcohol
Indications and Usage:
Indications and usage jeanatope i-125 is indicated for use in the determination of total blood and plasma volume.
Warnings:
Warnings a few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of this product in cisternography. this material is not approved for use in cisternography.
Dosage and Administration:
Dosage and administration radioiodinated serum albumin is administered intravenously. when a procedure such as a blood volume determination is to be repeated, the total dosage administered in any one week should not exceed 7.4 megabecquerels (200 microcuries). to minimize the uptake of radioactive iodine by the thyroid, prior administration of lugolâs solution (strong iodine solution usp) may be used. ten drops of lugolâs solution three times daily, beginning at least 24 hours before administration of iodinated serum albumin i-125 and continuing for one or two weeks thereafter, is a suitable dose. complete assay data for each vial are provided on the container. note: the expiration date given on the container pertains to the biologic properties of the material and not to the radioactivity level. it is important to make certain that the radioactivity in the dose at the time of administration is sufficient for the intended use. visual inspection: parenteral drug products should
Read more... be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. jeanatope (iodinated i-125 albumin injection) may be colorless to very pale yellow. solutions with excessive coloration should not be used. the patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. note: a shielded syringe should be used for withdrawing and injecting the iodinated i-125 albumin. total blood and plasma volumes dosage may range from .185 to 1.85 megabecquerels (5 to 50 microcuries). blood volume determination a. preparation of reference solution remove an aliquot of the contents of the vial to be used in the procedure identical in volume to the dose to be administered to the patient. prepare a reference solution using normal saline as a diluent. the recommended dilution is 1:4000 [dilution factor (df) = 4000]. determine the radioactivity concentration (net cpm/ml) of the reference solution. care must be taken to assure that the reference solution and the blood samples (step b3) are assayed using the same geometric configuration. b. administration of dose 1. inject the dose into a large vein in patientâs arm. measure the residual radioactivity in the syringe and needle. 2. destroy syringe after injecting. do not attempt to resterilize. caution: the syringe should be disposed of in accordance with the us nuclear regulatory commission or agreement state regulations pertaining to the disposal of radioactive waste. 3. at 5 and 15 minutes after injecting the dose, withdraw blood samples from the patientâs other arm with a sterile heparinized syringe. c. calculation of blood volume 1. take a known aliquot from each blood sample and determine radioconcentration in net cpm/ml. 2. plot the 5- and 15- minute sample counts (net cpm/ml) on semilog graph paper using the average count value of each sample and determine the radioconcentration at injection time (zero time) by drawing a straight line through the 15-and 5-minute points to zero time. the x ordinate of the graph is the sample withdrawal time and the logarithmic y ordinate is radioconcentration in net cpm/ml. 3. calculate patientâs blood volume (in ml) using the following formula: sample blood volume calculations volume of blood sample aliquot = 1.0 ml volume of reference solution aliquot = 1.0 ml net counts at zero time = 2500 net counts obtained from reference solution aliquot = 2725 serial blood volume determinations jeanatope (iodinated i-125 albumin injection) is administered in sufficiently low dosage to permit repetitions as often as required by clinical circumstances. it must be remembered that it is always necessary to correct for background radioactivity remaining in the blood from former determinations. therefore, for each determination after the first one, a background blood sample must be taken just before the iodinated i-125 albumin is injected. background blood sample: 1. prior to injecting jeanatope i-125, withdraw background blood sample from large vein in patientâs arm with a sterile heparinized syringe. 2. leaving needle in patientâs vein, detach syringe containing blood sample. 3. withdraw jeanatope i-125 from the vial and administer (see instructions under blood volume determination, administration of dose) . 4. determine radioconcentration in net cpm/ml of aliquots taken from background and postinjection blood samples, and from the reference solution. the radioconcentration (net cpm/ml) per aliquot of the background blood sample must be subtracted from the radioconcentration per aliquot of the blood sample obtained after the injection of iodinated i-125 albumin. the formula for calculating each blood volume determination after the first one thus becomes: plasma volume determination the procedure is essentially the same as that for blood volume determination, except that the blood sample drawn from the patient is centrifuged, the red blood cells are removed, and net cpm /ml of the plasma is determined. the formula for calculation of plasma volume, therefore is: radiation dosimetry the estimated absorbed radiation doses to an average patient (70 kg) from an intravenous injection of 1.85 megabecquerels (50 microcuries) of iodinated i-125 albumin usp are shown in table 4. method of calculation: hine gj, johnston re: absorbed doses from radionuclides, j. nucl med 11:468-469, 1970. for doses of 2.775, 5.55, 18.5 and 27.75 megabecquerels (75,150, 500 and 750 microcuries), the estimated absorbed doses are 1.5, 3, 10 and 15 times the number of rads given, respectively. formula1 formula2 formula3 formula4 table4
Contraindications:
Contraindications at present there are no known contraindications to the use of this preparation.
Adverse Reactions:
Adverse reactions although the immunological properties of serum albumin are believed to be virtually unaltered by the iodinated process, there is a theoretical possibility that allergic reactions may occur in patients receiving additional doses a number of weeks after an initial dose.
Description:
Description jeanatope i-125 (iodinated i-125 albumin injection) is a sterile, nonpyrogenic, aqueous solution for intravenous use. each milliliter provides approximately 10 mg protein (normal human serum albumin), 16 mg dibasic sodium phosphate, 1.6 mg monobasic sodium phosphate, not more than 0.4 mg guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. the ph has been adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid. jeanatope i-125 was prepared from blood that was nonreactive when tested for hepatitis b surface antigen (hbsag) and hiv antibody.
Clinical Pharmacology:
Clinical pharmacology following intravenous injection, radioiodinated serum albumin is uniformly distributed throughout the intravascular pool within 10 minutes; extravascular distribution takes place more slowly. labeled albumin also can be detected in the lymph and in certain body tissues within 10 minutes after injection, but maximum distribution of radioactivity throughout the extravascular space does not occur until two to four days after administration. the time at which extravascular activity is maximal has been designated as the âequilibrium time.â when this point has been reached, the radioactivity remaining in the intravascular and extravascular spaces decreases slowly and exponentially in parallel fashion. the administered radioactivity is eliminated almost entirely in the urine, only about 2 percent of the total dose ultimately appearing in the feces. the biologic half-life of labeled albumin is dependent upon a number of factors, and published studies have varied
Read more... considerably in their reporting of this figure. it has ranged, in the literature, from below 10 days to over 20 days. one important factor affecting the biologic half-life is the initial rate of excretion, and this depends in part on the quality of the labeled albumin. with jeanatope i-125, the biologic half-life in normal individuals has been reported to be approximately 14 days.
How Supplied:
How supplied jeanatope (iodinated i-125 albumin injection usp) is available in multiple dose vials containing the following amounts of activity on the date of calibration: 3.7 megabecquerels/10.0 ml (100 microcuries/10.0 ml), 18.5 megabecquerels/0.5 ml (500 microcuries/0.5 ml) and 37.0 megabecquerels/1.0 ml (1.0 millicuries/1.0 ml). complete assay data for each vial is provided on the container. the maximum concentration of iodinated i-125 injection does not exceed one millicurie per milliliter at time of calibration.
Package Label Principal Display Panel:
Packaging injection