FDA Label for Technelite
View Indications, Usage & Precautions
- INDICATIONS AND USAGE:
- GENERAL
- CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
- PREGNANCY CATEGORY C
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- RADIATION DOSIMETRY
- ASSAY INSTRUCTIONS FOR THE TECHNELITE®, TECHNETIUM TC 99M GENERATOR ELUATE
- RADIOMETRIC MOLYBDENUM TEST PROCEDURE
- COLORIMETRIC ALUMINUM ION TEST PROCEDURE
- PRINCIPAL DISPLAY PANEL - VIAL CARTON
Technelite Product Label
The following document was submitted to the FDA by the labeler of this product Lantheus Medical Imaging, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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:
Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for:
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.
| Organ | Absorbed Radiation Dose (mGy) for a 1110 MBq (30mCi) dose |
|---|---|
| To 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). | |
| Adrenals | 4.1 |
| Urinary Bladder Wall | 20 |
| Bone Surfaces | 6.2 |
| Brain | 2.2 |
| Breasts | 2 |
| Gallbladder Wall | 8.3 |
| Stomach Wall | 29 |
| Small Intestine | 18 |
| ULI Wall | 63 |
| LLI Wall | 23 |
| Heart Wall | 3.5 |
| Kidneys | 6 |
| Liver | 4.7 |
| Lungs | 2.9 |
| Muscle | 3.6 |
| Ovaries | 11 |
| Pancreas | 6.3 |
| Red Marrow | 4.1 |
| Skin | 2 |
| Spleen | 4.8 |
| Testes | 3.1 |
| Thymus | 2.7 |
| Thyroid | 24 |
| Uterus | 9 |
| Remaining Tissues | 3.9 |
| Effective Dose (mSv) | 14 |
| Age | 15 years | 10 years | 5 years | 1 year |
|---|---|---|---|---|
| To 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) |
| Organ | ||||
| Adrenals | 5.3 | 5.4 | 6.2 | 7.1 |
| Urinary Bladder Wall | 26 | 22 | 18 | 22 |
| Bone Surfaces | 7.6 | 7.5 | 8.1 | 10 |
| Brain | 2.8 | 3.1 | 3.7 | 4.5 |
| Breasts | 2.6 | 2.6 | 3.2 | 4.1 |
| Gallbladder Wall | 11 | 12 | 13 | 13 |
| Stomach Wall | 38 | 36 | 43 | 59 |
| Small Intestine | 22 | 23 | 26 | 30 |
| ULI Wall | 81 | 89 | 110 | 140 |
| LLI Wall | 31 | 33 | 40 | 48 |
| Heart Wall | 4.5 | 4.6 | 5.2 | 6.4 |
| Kidneys | 7.2 | 6.9 | 7.8 | 8.5 |
| Liver | 6 | 6.7 | 8 | 9.1 |
| Lungs | 3.8 | 3.8 | 4.4 | 5.3 |
| Muscle | 4.5 | 4.5 | 5 | 6 |
| Ovaries | 14 | 13 | 14 | 17 |
| Pancreas | 8.1 | 8.2 | 8.9 | 10 |
| Red Marrow | 5.1 | 5 | 5.2 | 6 |
| Skin | 2.5 | 2.6 | 3.2 | 3.8 |
| Spleen | 6 | 6 | 6.7 | 7.8 |
| Testes | 4.1 | 4.3 | 4.9 | 6 |
| Thymus | 3.6 | 3.5 | 4.2 | 5.3 |
| Thyroid | 40 | 41 | 67 | 81 |
| Uterus | 11 | 11 | 12 | 14 |
| Remaining Tissues | 4.8 | 4.8 | 5.4 | 6.4 |
| Effective Dose (mSv) | 19 | 19 | 23 | 29 |
The 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.
| Absorbed Dose | ||
|---|---|---|
| Target Organ | mGy/ 3.7MBq | (rad/ 100µCi) |
| * Assuming no blockage of drainage system | ||
| Eye 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 0.130 | 0.014 0.002 0.402 0.001 0.003 0.001 0.013 |
In 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.
| Age | Bladder wall dose, mGy (rad) | Gonadal dose, mGy (rad) |
|---|---|---|
| 1 year | 3.6 (0.36) | 0.15 (0.015) |
| 5 years | 2.0 (0.2) | 0.095 (0.0095) |
| 10 years | 1.3 (0.13) | 0.066 (0.0066) |
| 15 years | 0.92 (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 source
Divide 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.
Principal Display Panel - Vial Carton
515128-0811
Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection
TechneLite®
Molybdenum Mo 99-Technetium Tc 99m Generator
Rx only.
See Package Insert for dosing information.
Canadian Est. Lic. No. 101647-A AUSTR R 130301
Store at controlled room temperature 20° to 25°C
(68° to 77°F) [See USP]. Eluate must be used within
12 hours of elution.
CAUTION: This generator should not be dismantled.
Manufacturer:
Lantheus
Medical Imaging®
N. Billerica, Massachusetts 01862 USA
Canadian License Holder:
Lantheus MI Canada, Inc.
Montréal, Canada
Australian Sponsor:
Lantheus MI Australia Pty Ltd.
CAUTION:
RADIOACTIVE MATERIAL
515128-0811
Sterile, Non-Pyrogenic Diagnostic Agent for Intravenous Injection
TechneLite®
Molybdenum Mo 99-Technetium Tc 99m Generator
Rx only.
See Package Insert for dosing information.
Canadian Est. Lic. No. 101647-A AUSTR R 130301
Store at controlled room temperature 20° to 25°C
(68° to 77°F) [See USP]. Eluate must be used within
12 hours of elution.
CAUTION: This generator should not be dismantled.
Manufacturer:
Lantheus
Medical Imaging®
N. Billerica, Massachusetts 01862 USA
Canadian License Holder:
Lantheus MI Canada, Inc.
Montréal, Canada
Australian Sponsor:
Lantheus MI Australia Pty Ltd.
CAUTION:
RADIOACTIVE MATERIAL
* Please review the disclaimer below.