NDC 11994-091 Technelite

Technetium Tc99m Generator

NDC Product Code 11994-091

NDC 11994-091-01

Package Description: 1 VIAL in 1 CARTON > 12 mL in 1 VIAL

NDC 11994-091-03

Package Description: 1 VIAL in 1 CARTON > 16 mL in 1 VIAL

NDC 11994-091-04

Package Description: 1 VIAL in 1 CARTON > 18 mL in 1 VIAL

NDC 11994-091-05

Package Description: 1 VIAL in 1 CARTON > 20 mL in 1 VIAL

NDC 11994-091-06

Package Description: 1 VIAL in 1 CARTON > 24 mL in 1 VIAL

NDC 11994-091-07

Package Description: 1 VIAL in 1 CARTON > 30 mL in 1 VIAL

NDC 11994-091-09

Package Description: 1 VIAL in 1 CARTON > 40 mL in 1 VIAL

NDC 11994-091-10

Package Description: 1 VIAL in 1 CARTON > 50 mL in 1 VIAL

NDC 11994-091-11

Package Description: 1 VIAL in 1 CARTON > 60 mL in 1 VIAL

NDC 11994-091-12

Package Description: 1 VIAL in 1 CARTON > 72 mL in 1 VIAL

NDC 11994-091-13

Package Description: 1 VIAL in 1 CARTON > 80 mL in 1 VIAL

NDC 11994-091-36

Package Description: 1 VIAL in 1 CARTON > 4 mL in 1 VIAL

NDC 11994-091-73

Package Description: 1 VIAL in 1 CARTON > 8 mL in 1 VIAL

NDC 11994-091-92

Package Description: 1 VIAL in 1 CARTON > 10 mL in 1 VIAL

NDC Product Information

Technelite with NDC 11994-091 is a a human prescription drug product labeled by Lantheus Medical Imaging, Inc.. The generic name of Technelite is technetium tc99m generator. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Lantheus Medical Imaging, Inc.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Technelite Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TECHNETIUM TC-99M SODIUM PERTECHNETATE 250 mCi/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Lantheus Medical Imaging, Inc.
Labeler Code: 11994
FDA Application Number: NDA017771 What is the FDA Application Number?
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.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 11-01-1975 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Technelite Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Indications And Usage:

  • The Technelite generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Thyroid Imaging Salivary Gland Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux. Nasolacrimal Drainage System ImagingSodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Thyroid Imaging Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

General

As in the use of any radioactive material, care should be taken to minimize radiation exposure to the patient consistent with proper patient management and to ensure minimum radiation exposure to occupational workers.Since the eluate does not contain an antimicrobial agent, it should not be used after 12 hours from the time of TECHNELITE®, Technetium Tc 99m Generator elution.After the termination of the nasolacrimal imaging procedure, blowing the nose and washing the eyes with sterile distilled water or an isotonic sodium chloride solution will further minimize the radiation dose.Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No animal studies have been performed to evaluate carcinogenic potential or whether Sodium Pertechnetate Tc 99m affects fertility in males or females.

Pregnancy Category C

Animal reproductive studies have not been conducted with Sodium Pertechnetate Tc 99m. It is also not known whether Sodium Pertechnetate Tc 99m can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Pertechnetate Tc 99m Injection should be given to a pregnant woman only if clearly needed.Ideally examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

Sodium Pertechnetate Tc 99m is excreted in human milk during lactation; therefore formula feedings should be substituted for breast feeding.This radiopharmaceutical preparation should not be administered to pregnant or lactating women unless expected benefits to be gained outweigh the potential risks.

Pediatric Use

See INDICATIONS and DOSAGE AND ADMINISTRATION sections. Also see the description of additional risks under WARNINGS.

Geriatric Use

Clinical studies of TechneLite® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Radiation Dosimetry

The estimated absorbed radiation doses to an average ADULT and Pediatric patient from an intravenous injection of a maximum dose of 1110MBq (30 millicuries) of Sodium Pertechnetate Tc 99m Injection distributed uniformly in the total body are shown in Tables 5 and 6.Table 5. Adult Absorbed Radiation Doses (mGy) from Intravenous InjectionOrganAbsorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) doseTo obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).Adrenals4.1Urinary Bladder Wall20Bone Surfaces6.2Brain2.2Breasts2Gallbladder Wall8.3Stomach Wall29Small Intestine18ULI Wall63LLI Wall23Heart Wall3.5Kidneys6Liver4.7Lungs2.9Muscle3.6Ovaries11Pancreas6.3Red Marrow4.1Skin2Spleen4.8Testes3.1Thymus2.7Thyroid24Uterus9Remaining Tissues3.9Effective Dose (mSv)14Table 6. Pediatric Absorbed Radiation Doses (mGy) from Intravenous InjectionAge15 years10 years5 years1 yearTo obtain radiation absorbed dose in rads (30 mCi dose) from the above table, divide individual organ values by a factor of 10 (does not apply for effective dose).Administered activity in MBq (mCi)1110(30)740(20)555(15)370(10)OrganAdrenals5.35.46.27.1Urinary Bladder Wall26221822Bone Surfaces7.67.58.110Brain2.83.13.74.5Breasts2.62.63.24.1Gallbladder Wall11121313Stomach Wall38364359Small Intestine22232630ULI Wall8189110140LLI Wall31334048Heart Wall4.54.65.26.4Kidneys7.26.97.88.5Liver66.789.1Lungs3.83.84.45.3Muscle4.54.556Ovaries14131417Pancreas8.18.28.910Red Marrow5.155.26Skin2.52.63.23.8Spleen666.77.8Testes4.14.34.96Thymus3.63.54.25.3Thyroid40416781Uterus11111214Remaining Tissues4.84.85.46.4Effective Dose (mSv)19192329The estimated absorbed radiation doses to an average ADULT from the instillation of Sodium Pertechnetate Tc 99m Injection for imaging the nasolacrimal drainage system are shown in Table 7.Table 7. Absorbed Radiation Dose from Dacryoscintigraphy Using Sodium Pertechnetate Tc 99mAbsorbed Dose Target OrganmGy/ 3.7MBq(rad/ 100µCi)* Assuming no blockage of drainage systemEye Lens:  If lacrimal fluid turnover is 16%/min  If lacrimal fluid turnover is 100%/min  If drainage system is blocked Total Body* Ovaries* Testes* Thyroid*0.140 0.022 4.020 0.011 0.030 0.009 0.1300.014 0.002 0.402 0.001 0.003 0.001 0.013In pediatric patients, an average 30 minute exposure to 37MBq (1 millicurie) of Sodium Pertechnetate Tc 99m Injection following instillation for direct cystography, results in an estimated absorbed radiation dose shown in Table 8.Table 8. Pediatric Absorbed Radiation Dose from CystographyAgeBladder wall dose, mGy (rad)Gonadal dose,mGy (rad)1 year3.6 (0.36)0.15 (0.015)5 years2.0 (0.2)0.095 (0.0095)10 years1.3 (0.13)0.066 (0.0066)15 years0.92 (0.092)0.046 (0.0046)

Assay Instructions For The Technelite®, Technetium Tc 99M Generator Eluate

The TECHNELITE®, Technetium Tc 99m Generator Eluate may be assayed using an ionization chamber dose calibrator. The manufacturer's instructions for operation of the dose calibrator should be followed for measurement of Technetium Tc 99m and Molybdenum Mo99 activity in the generator eluate. The Molybdenum 99/Technetium 99m ratio should be determined at the time of elution prior to administration, and from that ratio, the expiration time (up to 12 hours) of the eluate mathematically determined. Each eluate should meet or exceed the purity requirements of the current United States Pharmacopeia; that is, not more than 0.0056MBq (0.15 microcurie) of Molybdenum 99 per 37MBq (1 millicurie) of Technetium 99m per administered dose at the time of administration.

Radiometric Molybdenum Test Procedure

  • This method is based on the fact that most Technetium Tc 99m radiation can be readily shielded and only the more energetic gamma rays from Molybdenum Mo99 (739KeV and 778KeV) are counted in the 550-850KeV energy range. The entire eluate may be assayed for Molybdenum Mo99 activity as follows:A Cesium Cs 137 reference source which has the same geometry as the generator eluate must be used to standardize the well counter.Determine the background after setting the window to the 550-850KeV energy range.Count the Technetium Tc 99m eluate in its lead shield (thereby shielding out Technetium Tc 99m) by placing over the well or probe.Count the Cs 137 reference source in the same shield geometry for the same time period.Compute Molybdenum Mo99 activity in the eluate as follows:µCi Molybdenum      =        µCi simulated Mo99 x net cpm Eluate  Mo99 (total)                        net cpm simulated Mo99 reference sourceDivide this number by the mCi of Technetium Tc 99m. This result (µCi Mo99/mCi Tc 99m) can be converted to MBq Mo99/MBq Tc 99m by multiplying by 10-3. The U.S. Pharmacopeia and the U.S. Nuclear Regulatory Commission or equivalent Agreement State regulations specify a limit of 0.00015MBq Molybdenum Mo99 per MBq of Technetium Tc 99m (0.15µCi Mo99/mCi Tc 99m) at the time of administration to each patient.

Colorimetric Aluminum Ion Test Procedure

Obtain an aluminum ion indicator kit and determine the aluminum ion concentration of the eluate per the manufacturer's instructions. The concentration must not exceed 10 micrograms per milliliter of eluate.

* Please review the disclaimer below.