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Search results for "VATC|DIAGNOSTIC RADIOPHARMACEUTICALS" in comments (approximate match)
Status:
US Approved Rx
(1982)
Source:
NDA017707
(1982)
Source URL:
First approved in 1982
Source:
NDA017707
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Indium In-111 pentetate disodium is a radioactive diagnostic indicated for use in radionuclide cisternography. Decay of In-111 by electron capture allows for detection with a gamma camera for visualization of the brain and spinal column. Indium In 111 pentetate ( 111In-DTPA) is indicated as an imaging agent in cisternography to study the flow of cerebrospinal fluid (CSF) in the brain, to diagnose abnormalities in CSF circulation, to assess and help localize the site of CSF leakage, and to test the patency of or localize blocks in CSF shunts.
Status:
US Approved Rx
(1979)
Source:
NDA018150
(1979)
Source URL:
First approved in 1977
Source:
THALLOUS CHLORIDE TL 201 by LANTHEUS MEDCL
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Thallous chloride (also known as Thallium(I) chloride) is a chemical compound with the formula TlCl. Thallous Chloride Tl 201 Injection is a diagnostic radiopharmaceutical indicated for:
Myocardial perfusion imaging with planar scintigraphy or single-photon emission computed tomography (SPECT) for the diagnosis of coronary artery disease by localization of:
Non-reversible defects (myocardial infarction) which may have prognostic value regarding survival.
Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress.
Localization of sites of parathyroid hyperactivity pre- and post-operatively in patients with elevated serum calcium and parathyroid hormone levels.
Status:
US Approved Rx
(1979)
Source:
NDA018058
(1979)
Source URL:
First approved in 1976
Source:
GALLIUM CITRATE GA 67 by LANTHEUS MEDCL
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Gallium citrate Ga 67 is the citrate salt of the radioisotope gallium Ga 67. Although the mechanism is unknown, gallium Ga 67 concentrates in lysosomes and is bound to a soluble intracellular protein in certain viable primary and metastatic tumors and focal sites of inflammation, allowing scintigraphic localization. Ga-67 scintigraphy (GS) cannot differentiate between tumor and acute inflammation. Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in the absence of prior symptoms warrants follow-up as an indication of a potential disease state.
Status:
US Approved Rx
(1989)
Source:
ANDA071910
(1989)
Source URL:
First approved in 1976
Source:
SODIUM IODIDE I 123 by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Iodide ion I-123 is the most suitable isotope of iodine for the diagnostic study of thyroid diseases. Sodium Iodide I 131 Capsules Diagnostic is indicated for use in adults for: Assessment of thyroid function using radioactive iodine (RAI) uptake test and Imaging the thyroid (scintigraphy). The following adverse reaction has been described elsewhere in the labeling: Hypersensitivity Reactions. The following adverse reactions have been identified during post-approval use from Sodium Iodide I 131 Capsules Diagnostic: Gastrointestinal disorders (vomiting, nausea, and diarrhea); General disorders and administration site conditions (local thyroid swelling); Immune system disorders (hypersensitivity reactions); Skin and subcutaneous tissue disorders (itching, rash, hives, and erythema). Certain drugs and iodine-containing foods interfere with the accumulation of radioiodide by the thyroid.
Status:
US Approved Rx
(1974)
Source:
NDA017279
(1974)
Source URL:
First approved in 1974
Source:
NDA017279
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Iothalamic acid is a Radiographic Contrast Agent. The mechanism of action of iothalamic acid is as a X-Ray Contrast Activity. GLOFIL-125 (Sodium Iothalamate I-125 Injection) is a sterile, nonpyrogenic aqueous injection containing approximately 1 mg sodium iothalamate per mL, and 0.9 percent benzyl alcohol as a preservative. The radioactive concentration of the material is 250-300 µCi/mL as of the calibration date. Sodium bicarbonate and hydrochloric acid are present for pH adjustment. GLOFIL-125 (Sodium Iothalamate I-125 Injection) is indicated for evaluation of glomerular filtration in the diagnosis or monitoring of patients with renal disease. The renal clearance of sodium iothalamate in man closely approximates that of inulin. The compound is cleared by glomerular filtration without tubular secretion or reabsorption. Following infusion administration of I-125 iothalamate, the effective half-life is about 0.07 days.
Status:
US Approved Rx
(1990)
Source:
NDA019785
(1990)
Source URL:
First approved in 1973
Source:
NDA017243
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Approved Rx
(1990)
Source:
NDA019785
(1990)
Source URL:
First approved in 1973
Source:
NDA017243
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Approved Rx
(1990)
Source:
NDA019785
(1990)
Source URL:
First approved in 1973
Source:
NDA017243
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Approved Rx
(1990)
Source:
NDA019785
(1990)
Source URL:
First approved in 1973
Source:
NDA017243
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.
Status:
US Approved Rx
(1990)
Source:
NDA019785
(1990)
Source URL:
First approved in 1973
Source:
NDA017243
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Molybdenum-99 (99Mo, half-life = 66 h) is a parent radionuclide of a diagnostic nuclear isotope. It decays in technetium-99 m (half-life = 6 h), which is used in over 30 million procedures per year around the world. Between 95 and 98 percent of Mo-99 is currently being produced using highly enriched uranium (HEU) targets. Other medical isotopes such as iodine-131 (I-131) and xenon-133 (Xe-133) are by-products of the Mo-99 production process and will be sufficiently available if Mo-99 is available.