Megatope

Iodinated I-131 Albumin


Iso-tex Diagnostics, Inc.
Human Prescription Drug
NDC 50914-7731
Megatope also known as Iodinated I-131 Albumin is a human prescription drug labeled by 'Iso-tex Diagnostics, Inc.'. National Drug Code (NDC) number for Megatope is 50914-7731. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Megatope drug includes Iodinated I-131 Serum Albumin - 1 mCi/mL . The currest status of Megatope drug is Active.

Drug Information:

Drug NDC: 50914-7731
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: Megatope
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:IODINATED I-131 SERUM ALBUMIN - 1 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 Jun, 1990
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.
NUI:N0000000205
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
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 MOA:Radiopharmaceutical Activity [MoA]
Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`.
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
50914-7731-48 mL in 1 VIAL, MULTI-DOSE (50914-7731-4)01 Jun, 1990N/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:

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

Indications and Usage:

Indications and usage megatope (iodinated i 131 albumin injection) is indicated for use in determinations of total blood and plasma volumes, cardiac output, cardiac and pulmonary blood volumes and circulation times, and in protein turnover studies, heart and great vessel dilineation, localization of the placenta, and localization of celebral neospasms.

Warnings:

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

Dosage and Administration:

Dosage and administration megatope (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. megatope (iodinated i 131 albumin injection) may be colorless to very pale yellow. solutions with excessive colorations should not be used. when a procedure such as 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 megatope 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. 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 131 albumin total blood and plasma volumes dosage may range from 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. a. administration of dose 1. inject the dose into a large vein in patient's arm. measure the residual radioactivity in the syringe and needle. 2. destroy the 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 patient's other arm with a sterile heparinized syringe. b. 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 iof the graph is the sample withdrawal time and the logarithmic y ordinate is radioconcentration in net cpm/ml. 3. calculate the patient's blood volume (in ml) using the following formula: net cpm/ml reference solution × df = blood volume (in ml) net cpm/ml patient's blood sample 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 using the formula above 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: 1. withdraw background blood sample from large vein in patient's arm with a sterile heparinized syringe. 2. leaving needle in patient's vein, detach syringe containing blood sample. 3. attach syringe containing the dose of megatope to the indwelling needle 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 131 albumin. the formula for calculating each blood volume determination after the first one thus becomes: net cpm/ml reference solution × df = blood net cpm/ml net cpm/ml volume postinjection minus background blood sample blood sample (in ml) 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 × df = plasma volume net cpm/ml patient's plasma sample (in ml) cardiac output dosage generally ranges from 3 to 50 microcuries. cardiac and pulmonary blood volumes; circulation times dosages used have generally been 75 to 130 microcuries. 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. heart and great vessel delineation the suggested dosage is 5 microcuries per kg of body weight, although doses up to 750 microcuries have been used, depending on the instrumentation available and the scanning technique employed. localization of the placenta for localization of the placenta in the differential diagnosis of placenta praevia, a 3 to 5 microcurie dose is recommended; this dose has proved adequate for excellent localization, and the fetal total body radiation is a fraction of that received during x-ray placentography. while fetal thyroid irradiation is higher with iodinated i 131 albumin injection than with x-ray placentography, the administration of lugol's solution is reported to eliminate this hazard. localization of celebral neospasms the suggested dosage is 5 microcuries per kg of body weight. although doses as large as 500 microcuries of iodinated i 131 albumin injection have been used, the dose should be kept as small as possible. dosage is administered six hours before the initial examination, and scans are repeated at periodic intervals. 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. 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 megatope (iodinated i 131 albumin injection) is a diagonostic radiopharmaceutical containing iodinated i 131 albumin for intravenous use. each ml of sterile, nonpyro- genic, aqueous, colorless to very pale yellow solution provides approximate 10 mg protein (albumin human), 16 mg dibasic sodium phosphate, 1.6 mg monobasic sodium phosphate, not more than 0.4 guanidine hydrochloride, sodium chloride for isotonicity, and 9 mg benzyl alcohol as a preservative. the ph has been adjusted to 7.2 to 7.8 with sodium hydroxide or hydrochloric acid. megatope was prepared from blood that was nonreactive when tested for hepatitis b surface antigen (hbsag). 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 can also 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 studies have v
aried 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 biological half-life is the initial rate of excretion, and this depends in part on the quality of the iodinated i 131 albumin. with megatope, the biologic half-life in normal individuals has been reported to be approximately 14 days.`

How Supplied:

How supplied megatope (iodinated i 131 albumin injection usp) is available in multiple dose vials containing the following amounts of activity on the date of calibration: 500 microcuries and 1.0 millicurie. complete assay data for each vial are provided on the container. the maximum concentration of iodinated i 131 albumin injection does not exceed one millicurie per milliliter at a time of calibration.

Package Label Principal Display Panel:

Packaging megatope


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