Important Safety Information for TechneLite
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.
CONTRAINDICATIONS:
IMPORTANT SAFETY INFORMATION:
Allergic reactions including anaphylaxis have been reported infrequently following the administration of Sodium Pertechnetate Tc 99m Injection.
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.
PRECAUTIONS
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. As in the use of any radioactive material, care should be taken to minimize radiation exposure to patients and occupational workers. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience and who are licensed in the safe handling of radionuclides.
Important Safety Information for CardioLite
INDICATIONS AND USAGE
Myocardial Imaging: CardioLite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (nonreversible defects), in evaluating myocardial function and developing information for use in patient management decisions. CardioLite® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).
CONTRAINDICATIONS
IMPORTANT SAFETY INFORMATION
CardioLite® has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during CardioLite® imaging. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell.
Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.
WARNINGS AND PRECAUTIONS
In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure.
Caution should be exercised and emergency equipment should be available when administering CardioLite®.
Before administering CardioLite® patients should be asked about the possibility of allergic reactions to either CardioLite® or Miraluma®. Miraluma® is an identical compound used in breast imaging.
The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
Important Safety Information for NeuroLite
INDICATIONS
NEUROLITE® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed.
NEUROLITE® is not indicated for assessment of functional viability of brain tissue or for distinguishing between stroke and other brain lesions.
CONTRAINDICATIONS
IMPORTANT SAFETY INFORMATION
In clinical trials, NEUROLITE® has been administered to 1063 subjects (255 normals, 808 patients). In the 808 patients with neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to NEUROLITE®.
The following adverse effects were observed in ≤ 1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.
WARNINGS
PRECAUTIONS
USE WITH CAUTION IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT. TECHNETIUM Tc99m BICISATE IS ELIMINATED PRIMARILY BY RENAL EXCRETION. WHETHER TECHNETIUM Tc99m BICISATE IS DIALYZABLE IS NOT KNOWN. DOSE ADJUSTMENTS IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT HAVE NOT BEEN STUDIED.
Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs.
As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
Important Safety Information for Xenon
INDICATIONS AND USAGE
Inhalation of Xenon Xe-133 Gas has proved valuable for the evaluation of pulmonary function and for imaging the lungs. It may also be applied to assessment of cerebral flow.
CONTRAINDICATIONS
None known.
IMPORTANT SAFETY INFORMATION
Adverse reactions related to the use of this agent have not been reported to date.
WARNINGS
Xenon Xe-133 Gas delivery systems, i.e., respirators or spirometers, and associated tubing assemblies must be leak-proof to avoid loss of radioactivity into environs not specifically protected by exhaust systems. Xenon Xe-133 adheres to some plastics and rubber and should not be allowed in tubing or respirator containers. The unrecognized loss of radioactivity from the dose for administration may render the study non-diagnostic. The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.
PRECAUTIONS
General
Xenon Xe-133, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to patients and to clinical personnel. Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
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