Technescan Mag3
Technescan Tc 99m Mertiatide
Curium Us Llc
Human Prescription Drug
NDC 69945-096Technescan Mag3 also known as Technescan Tc 99m Mertiatide is a human prescription drug labeled by 'Curium Us Llc'. National Drug Code (NDC) number for Technescan Mag3 is 69945-096. This drug is available in dosage form of Injection, Powder, Lyophilized, For Solution. The names of the active, medicinal ingredients in Technescan Mag3 drug includes Betiatide - 1 mg/1 . The currest status of Technescan Mag3 drug is Active.
Drug Information:
| Drug NDC: | 69945-096 |
| 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: | Technescan Mag3 |
| 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: | Technescan Tc 99m Mertiatide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Curium Us Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Powder, Lyophilized, For 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: | BETIATIDE - 1 mg/1
|
| 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: | 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: | 15 Jun, 1990 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 02 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: | NDA019882 |
| 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: | Curium US 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: | 9NV2SR34P8
|
| 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 |
|---|
| 69945-096-20 | 5 VIAL in 1 CELLO PACK (69945-096-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 15 Jun, 1990 | 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:
Technescan mag3 technescan tc 99m mertiatide betiatide betiatide stannous chloride stannous chloride anhydrous sodium tartrate lactose monohydrate sodium hydroxide hydrochloric acid
Indications and Usage:
Indications and usage technetium tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (see pediatric use. ) it is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
Warnings:
Warnings none known.
General Precautions:
General the contents of this kit are not radioactive. however, after sodium pertechnetate tc 99m is added, adequate shielding of the final preparation must be maintained. contents of the reaction vial are intended only for use in the preparation of technetium tc 99m mertiatide and are not to be administered directly to the patient. to help reduce the radiation dose to the bladder, as well as other target organs, the patient should increase his or her fluid intake (unless medically contraindicated) and void as often as possible after the injection of technetium tc 99m mertiatide for six hours after the imaging procedure. technetium tc 99m mertiatide should not be used more than six hours after preparation. the components of the kit are sterile and nonpyrogenic. it is essential that the user follow the directions carefully and use aseptic procedures normally employed in making additions and withdrawals from sterile, nonpyrogenic containers during the addition of pertechnetate solution an
Read more...d the withdrawal of doses for patient administration. the technetium tc 99m labeling reactions involved in preparing technescan mag3 depend on maintaining the stannous ion in the reduced state. any oxidant present in the sodium pertechnetate tc 99m may adversely affect the quality of the radiopharmaceutical. therefore, sodium pertechnetate tc 99m containing oxidants should not be employed. as in the use of any other radioactive material, care should be taken to ensure minimum radiation exposure to the patient and to occupational workers. radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
Dosage and Administration:
Dosage and administration the suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 mbq (5 mci) to 370 mbq (10 mci). in pediatric patients the recommended dose range is 2.6 mbq/kg (70 μci/kg) to 5.2 mbq/kg (140 μci/kg) with a minimum dose of 37 mbq (1 mci). the patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. the user should wear waterproof gloves during the administration procedure.
Contraindications:
Contraindications none known.
Adverse Reactions:
Adverse reactions the following adverse reactions have been reported: nausea, vomiting, wheezing, dyspnea, itching, rash, tachycardia, hypertension, shaking chills, fever, and seizure.
Use in Pregnancy:
Pregnancy pregnancy category c. animal reproduction studies have not been conducted with technetium tc 99m mertiatide. it is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. technetium tc 99m mertiatide should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness in pediatric patients under the age of 30 days have not been established.
Description:
Description technescan mag3⢠is a kit for the preparation of technetium tc 99m mertiatide, a diagnostic radiopharmaceutical. it is supplied as a sterile, nonpyrogenic, lyophilized powder. each vial contains betiatide (n-[n-[n-[(benzoylthio) acetyl]glycyl]glycyl]-glycine). after reconstitution with sterile sodium pertechnetate tc 99m injection, the technetium tc 99m mertiatide (disodium[n-[n-[n-(mercaptoacetyl) glycyl]glycyl] glycinato (2-) - n,nâ²,nâ³,sâ²]oxotechnetate (2-)) which is formed is suitable for intravenous administration. each 10 milliliter vial contains 1 milligram betiatide, 0.05 milligram (minimum) stannous chloride dihydrate (sncl 2 â¢2h 2 o) and 0.2 milligram (maximum) total tin expressed as stannous chloride dihydrate (sncl 2 â¢2h 2 o), 40 milligrams sodium tartrate dihydrate (na 2 c 4 h 2 o 6 â¢2h 2 o), and 20 milligrams lactose monohydrate. prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for ph adjustment. the ph of the reconstituted drug is between 5.0 and 6.0. no bacteriostatic preservative is present. the contents are sealed under argon. betiatide is light sensitive and must be protected from light. betiatide and technetium tc 99m mertiatide have the following structural formulas: chemical structure chemical structure
Clinical Pharmacology:
Clinical pharmacology following intravenous injection of technetium tc 99m mertiatide, the appearance, concentration, and excretion of the tracer in the kidney can be monitored to assess renal function. although technetium tc 99m mertiatide is highly plasma protein bound following intravenous injection, the protein binding is reversible and the tracer is rapidly excreted by the kidneys via active tubular secretion and glomerular filtration. following intravenous injection of technetium tc 99m mertiatide in normal volunteers, 89% of the tracer was plasma protein bound. in healthy subjects with normal renal function (mean serum creatinine 1.2 mg/dl) technetium tc 99m mertiatide was rapidly cleared from the blood. the plasma clearance was approximately 0.3 liters/minute and the amount of technetium tc 99m mertiatide excreted in the urine in three hours was nearly 90% of the dose. in a study performed in three patients with renal impairment (serum creatinine greater than 6.3 mg/dl), there
Read more...was decreased blood clearance and a decrease in the amount excreted in the urine over three hours. in these patients, 78% of the tracer was plasma protein bound after intravenous injection. the mean plasma clearance of technetium tc 99m mertiatide was 0.03 liters/minute and 21.3% was excreted in three hours on average. in both healthy subjects and patients with renal impairment, the plasma concentration-time profile showed a biexponential decline.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females.
How Supplied:
How supplied catalog number 096. technescan mag3 is supplied as a lyophilized powder packaged in vials. each reaction vial contains 1 mg betiatide, 0.05 mg (minimum) stannous chloride dihydrate (sncl 2 â¢2h 2 o), 0.2 mg (maximum) total tin expressed as stannous chloride dihydrate (sncl 2 â¢2h 2 o), 40 mg sodium tartrate dihydrate (na 2 c 4 h 2 o 6 â¢2h 2 o), and 20 mg lactose monohydrate. the ph of the reconstituted drug is between 5.0 and 6.0. no bacteriostatic preservative is present. packages containing 5 reaction vials (ndc 69945-096-20) are available.
Package Label Principal Display Panel:
Principal panel display - a096v0 technescan mag3 ⢠kit for the preparation of technetium tc 99m mertiatide diagnostic vial contains: 1 mg betiatide 0.05 mg (minimum) stannous chloride dihydrate (sncl 2 â 2h 2 o) 40 mg sodium tartrate dihydrate 0.2 mg (maximum) total tin as stannous chloride dihydrate (sncl 2 â 2h 2 o) 20 mg lactose monohydrate prior to lyophilization, sodium hydroxide or hydrochloric acid may be added for ph adjustment. the ph of the reconstituted drug is between 5.0 and 6.0. the contents are sealed under argon. sterile, non-pyrogenic. for intravenous use after drug preparation. see package insert for directions for use. store at 20Ë to 25Ëc (68Ë to77Ëf) and protect from light. do not use sodium pertechnetate tc 99m solutions containing an oxidizing agent. rx only manufactured by: curium us llc maryland heights, mo 63043 made in usa curium tm a096v0 r12/2018 panel display a096vo