Volumex

Iodinated I-131 Albumin


Iso-tex Diagnostics, Inc.
Human Prescription Drug
NDC 50914-7720
Volumex also known as Iodinated I-131 Albumin is a human prescription drug labeled by 'Iso-tex Diagnostics, Inc.'. National Drug Code (NDC) number for Volumex is 50914-7720. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Volumex drug includes Human Serum Albumin I-131 - .025 mCi/mL . The currest status of Volumex drug is Active.

Drug Information:

Drug NDC: 50914-7720
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: Volumex
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-131 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-131 - .025 mCi/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: 01 Aug, 1993
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 01 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: BLA017837
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:ACH35131L1
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:Radiopharmaceutical Activity [MoA]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
50914-7720-81 mL in 1 SYRINGE, PLASTIC (50914-7720-8)01 Aug, 1993N/ANo
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:

Volumex iodinated i-131 albumin human serum albumin i-131 human serum albumin i-131 albumin human benzyl alcohol

Indications and Usage:

Indications and usage volumex (iodinated i 131 allbumin injection) is indicated for use in determinations of total blood and plasma volumes and in protein turnover studies

Warnings:

Warnings a few instances of hyperpyrexia and aseptic (chemical) meningeal irritation have been reported with the use of iodinated i 131 albumin in cisternography. iodinated i 131 albumin injection is not approved for use in cisternography.

Dosage and Administration:

Dosage and administration volumex (iodinated i 131 albumin injection) is administered intravenously. parenteral drug products should be inspected visually for particulate matter and abnormal coloration prior to administration whenever solution and container permit. volumex (iodinated i 131 albumin injection) may be colorless to very pale yellow. solutions with excessive coloration should not be used. when a procedure such as a blood volume or a circulation time determination is to be repeated, the total dosage administered in any one week should not exceed 200 microcuries. to minimize the uptake of radioactive iodine by the thyroid, prior administration of lugol’s solution (strong iodine solution usp) may be used. ten drops of lugol’s solution three times daily, beginning at least 24 hours before administration of volumex and continuing for one or two weeks thereafter, is a suitable dose. complete assay data for each single unit dose are provided on the container. note: the e
xpiration 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. the patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. note: a shielded syringe may be used for withdrawing and injecting the iodinated i 131 albumin. total blood and plasma volumes dosage may range from 5 to 50 microcuries. blood volume determination a. reference solution reference solution is provided with each single unit dose of volumex. 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 after withdrawing a background blood sample as described below, insert an intravenous (iv) line into a large vein in patient’s arm. inject the entire volumex dose (one milliliter) through the iv line for immediate delivery.measure the residual radioactivity in the syringe and needle. 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. at 12, 18, 24, 30 and 36 minutes after injecting the dose, withdraw blood samples from the patient with a sterile syringe or evacuated sample tube containing anti-coagulant. c. calculation of blood volume 1. take a known aliquot from each blood sample and determine radioconcentration in net cpm/ml. 2. plot the 12, 18, 24, 30 and 36 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 12, 18, 24, 30 and 36 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 patient’s blood volume (in ml) using the following formula: net cpm/ml reference solution blood net cpm/ml patient’s blood sample x df = volume (in ml) 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 = 48,100 net counts obtained from reference solution aliquot = 52, 430 if, for example, df, dilution factor of the reference solution = 4000 using the above formula gives = 52,430 x 4000 = 4360 ml 48,100 serial blood volume determinations iodinated i 131 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 131 albumin is injected. background blood sample withdraw background blood sample from large vein in patient’s sampling arm with a sterile syringe or evacuated sampling tube containing anti-coagulant. leaving needle in patient’s vein, detach syringe containing blood sample. attached syringe containing the dose of volumex to the indwelling iv line and administer (see instructions under blood volume determination, administration of dose ). 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 bloodsample must be subtracted from the radioconcentration per aliquot of the blood sample obtained after the injection of iodinated i 131 albumin. the formula for calculating each blood volume determination after the first one thus becomes: net cpm/ml reference solution blood x df = blood net cpm/ml net cpm/ml volume postinjection minus background (in ml) blood sample blood sample 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: net cpm/ml reference solution x df = plasma net cpm/ml patient’s plasma sample volume (in ml) protein turnover studies dosages used have ranged from 10 to 150 microcuries. after injection, a period of seven days should be allowed before determinations are made to permit the elimination of any degraded protein in the dose. radiation dosimetry the estimated absorbed radiation doses to an average patient (70 kg) from an intravenous injection of 50 microcuries of iodinated i 131 albumin injection usp are shown in table 4. for doses of 10, 25, 75, 150, 500 and 750 microcuries, the estimated absorbed doses are 0.2, 0.5, 1.5, 3, 10 and 15 times the number of rads given, respectively. table 4

Contraindications:

Contraindications none known.

Adverse Reactions:

Adverse reactions although the immunological properties of albumin human are believed to be virtually unaltered by the iodination 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 volumex (iodinated i 131 albumin injection) is a diagnostic radiopharmaceutical containing iodinated i 131 albumin for intravenous use. each ml of sterile, nonpyrogenic, aqueous, colorless to very pale yellow solution provides approximately 10 mg protein (albumin human), 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 stabilizer acetyltryptophanate and sodium caprylate have a concentration of less than 0.0089m. the ph has been adjusted to 7.2-7.8 with sodium hydroxide or hydrochloric acid. volumex was prepared from blood that was nonreactive when tested for hepatitis b surface antigen (hb s ag). the structure of the complex is unknown.

Clinical Pharmacology:

Clinical pharmacology following intravenous injection, radioiodinated albumin human is uniformly distributed throughout the intravascular pool within 10 minutes; extravascular distribution takes place more slowly. iodinated i 131 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 “equilibrium time.” 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 iodinated i 131 albumin is dependent upon a number of factors, and published stu
dies have varied 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 iodinated i 131 albumin. with volumex, the biologic half-life in normal individuals has been reported to be approximately 14 days.

How Supplied:

How supplied volumex (iodinated i 131 albumin injection usp) is available in single unit dose syringes containing 25 microcuries of activity in one milliliter per syringe on the date of calibration. each single unit dose syringe is supplied with reference solution. complete assay data for each single unit dose syringe and reference solution are provided on their respective containers. the maximum concentration of a single unit dose syringe of volumex does not exceed 26.3 microcuries per milliliter at time of calibration

Package Label Principal Display Panel:

Packaging volumex


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