TechneLite 250 mCi/mL
Technetium Tc99m Generator · INJECTION, SOLUTION · Lantheus Medical Imaging, Inc.
TechneLite is a injection, solution containing technetium tc99m generator at 250 mCi/mL, taken intravenous. Manufactured by Lantheus Medical Imaging, Inc..
Key Facts
- Brand Name
- TechneLite
- Generic Name
- Technetium Tc99m Generator
- NDC Code (Product)
11994-090- Manufacturer
- Lantheus Medical Imaging, Inc.
- Strength
- 250 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA017771
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 11/01/1975
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 Imaging Sodium 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Sodium Pertechnetate Tc 99m Injection is usually administered by intravascular injection. For imaging the urinary bladder and ureters (direct isotopic cystography), the Sodium Pertechnetate Tc 99m Injection is administered by direct instillation aseptically into the bladder via a urethral catheter, following which the catheter is flushed with approximately 200 mL of 0.9% Sodium Chloride Injection, USP directly into the bladder. The dosage employed varies with each diagnostic procedure. When imaging the nasolacrimal drainage system, instill the Sodium Pertechnetate Tc 99m Injection by the use of a device such as a micropipette or similar method which will ensure the accuracy of the dose. The suggested dose range employed for various diagnostic indications in the average ADULT PATIENT (70kg) is: Vesico-ureteral Imaging 18.5 to 37MBq (0.5 to 1mCi) Thyroid Gland Imaging 37 to 370MBq (1 to 10mCi) Salivary Gland Imaging 37 to 185MBq (1 to 5mCi) Nasolacrimal Drainage System Maximum 3.7MBq (100µCi) The recommended dosage range in PEDIATRIC PATIENTS is: Vesico-ureteral Imaging 18.5 to 37MBq (0.5 to 1mCi) Thyroid Gland Imaging 2.22 to 2.96MBq (60 to 80µCi)/kg body …
Warnings
WARNINGS: Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life-expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Contraindications
CONTRAINDICATIONS: None known.
Adverse Reactions
ADVERSE REACTIONS: Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.
Frequently Asked Questions
What is TechneLite used for?
TechneLite contains Technetium Tc99m Generator. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is TechneLite a controlled substance?
TechneLite is not classified as a controlled substance by the DEA.
What is the generic name for TechneLite?
The generic name for TechneLite is Technetium Tc99m Generator. There are no other listed brand versions of Technetium Tc99m Generator.
What is the NDC code for TechneLite 250 mCi/mL?
The NDC (National Drug Code) for TechneLite 250 mCi/mL is 11994-090, listed by Lantheus Medical Imaging, Inc..
Other TechneLite Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)