Australia - English - Department of Health (Therapeutic Goods Administration)

global medical solutions australia pty limited t/a radpharm scientific - tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate, quantity: 1 mg - injection, powder for - excipient ingredients: cysteine hydrochloride; stannous chloride dihydrate; sodium citrate dihydrate; mannitol - technetium (99mtc) sestamibi is indicated for use in conjunction with stress testing as an adjunct in the diagnosis of ischaemic heart disease. in these patients additional information about ventricular function may be derived by using the first pass technique. indications as at 23 november 1999: technetium [99mtc] sestamibi is indicated for use in conjunction with stress testing as an adjunct in the diagnosis of ischaemic heart disease. in these patients additional information about ventricular function may be derived by using the first pass technique. technetium [99mtc] sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive.

United States - English - NLM (National Library of Medicine)

jubilant draximage (usa) inc. - technetium tc-99m sestamibi (unii: 971z4w1s09) (technetium tc-99m sestamibi - unii:971z4w1s09) - tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate 1 mg in 1 ml - myocardial imaging: kit for the preparation of technetium tc 99m sestamibi injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. technetium tc 99m sestamibi 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 agents labeling). it is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. breast imaging: kit for the preparation of technetium tc 99m sestamibi injection is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. kit f

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - technetium tc-99m sestamibi (unii: 971z4w1s09) (technetium tc-99m sestamibi - unii:971z4w1s09) - technetium tc-99m sestamibi 1 mg in 10 ml - myocardial imaging: technetium tc 99m sestamibi injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. technetium tc 99m sestamibi 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). it is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. breast imaging: technetium tc 99m sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. technetium tc 99m sestamibi is not indicated for breast cancer scree

United States - English - NLM (National Library of Medicine)

cardinal health 414, llc - technetium tc-99m sestamibi (unii: 971z4w1s09) (technetium tc-99m sestamibi - unii:971z4w1s09) - technetium tc-99m sestamibi 1 mg in 5 ml - myocardial imaging: technetium tc 99m sestamibi injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. technetium tc 99m sestamibi 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). it is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. breast imaging: technetium tc 99m sestamibi is indicated for planar imaging as a second line diagnostic drug after mammography to assist in the evaluation of breast lesions in patients with an abnormal mammogram or a palpable breast mass. technetium tc 99m sestamibi is not indicated for breast cancer scree

United States - English - NLM (National Library of Medicine)

medi-physics inc. - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - technetium tc-99m exametazime 0.5 mg in 5 ml - technetium tc99m exametazime scintigraphy (with or without methylene blue stabilization) may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. tc99m exametazime without methylene blue stabilization is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. none known. the technetium tc99m labeling reaction involved in preparing technetium tc99m exametazime injection depends on maintaining tin in the divalent (reduced) state. any oxidant present in the sodium pertechnetate tc99m employed may adversely affect the quality of the preparation. sodium pertechnetate tc99m containing oxidants should not be used for the preparation of the labeled product. to meet the last requirement, a generator must be eluted within 24 hours prior to obtaining any elute for reconstitution with the ceretec kit. sodium chloride injection, usp must be used as the diluent. do not use bacteriostatic sodium chloride as a diluent for sodium pertechnetate tc99m injection because it will increase the oxidation products and adversely affect the biological distribution of ceretec. the contents of the ceretec vial are sterile and pyrogen free. the vial contains no bacteriostatic preservative. it is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation of the radiopharmaceutical. technetium tc99m exametazime injection, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. care should also be taken to minimize radiation exposure to the patient consistent with proper patient management. care should be taken when handling blood specimens to be labeled using this radiopharmaceutical. even if the subject has been tested, no method can offer complete assurance that hepatitis b virus, human immuno-deficiency virus (hiv) or other infectious agents are absent. all human blood samples should be considered potentially infectious. precautions for handling are as those for handling radioactive materials. note: do not use this procedure for leukocyte labeling. see procedure for the radiolabeling of autologous leukocytes with technetium tc99m exametazime injection. note: sterile technique must be used throughout. the user should wear waterproof gloves during the handling and administration procedure. note: sterile technique must be used throughout. the user should wear waterproof gloves during the handling and administration procedure. note: sterile technique must be used throughout. the user should wear waterproof gloves during the handling and administration procedure. radiochemical purity determination must be performed before administration to the patient. three potential radiochemical impurities may be present in the prepared injection of the lipophilic technetium tc99m exametazime complex. these are a secondary technetium tc99m exametazime complex, free pertechnetate, and reduced-hydrolyzed-technetium tc99m. a combination of 3 chromatographic systems is necessary for the complete definition of the radiochemical composition of the injection. the following protocol has been designed to enable analysis of the radiochemical purity of ceretec (99mtc-exametazime). it should be started within 2 minutes of reconstitution. the entire procedure takes approximately 15 minutes. secondary tc exametazime complex and reduced-hydrolyzed-tc remain at the origin. lipophilic tc exametazime complex and pertechnetate migrate at rf 0.8-1.0. lipophilic-tc exametazime complex, secondary tc exametazime complex and reduced-hydrolyzed-tc remain at the origin. pertechnetate migrates at rf 0.8-1.0. reduced-hydrolyzed-tc remains at the origin. lipophilic tc exametazime complex, secondary tc exametazime complex and pertechnetate migrate at rf 0.8-1.0.

United States - English - NLM (National Library of Medicine)

pharmalucence, inc. - technetium tc-99m disofenin (unii: qtj2viw97t) (technetium tc-99m disofenin - unii:qtj2viw97t) - disofenin 20 mg in 10 ml - technetium tc99m disofenin is indicated as a hepatobiliary imaging agent. hepatolite is indicated in the diagnosis of acute cholecystitis as well as to rule out the occurrence of acute cholecystitis in suspected patients with right upper quadrant pain, fever, jaundice, right upper quadrant tenderness and mass or rebound tenderness, but not limited to these signs and symptoms. in otherwise healthy individuals, non-visualization of the gallbladder 4 hours after administration of hepatolite following a 2-6 hour fast and in the presence of activity in the small intestine is indicative of a diagnosis of acute cholecystitis. under the same conditions in an otherwise healthy person, visualization of the gallbladder during a 1 hour scintigraphy is effective in excluding a diagnosis of acute cholecystitis. if the gallbladder is not visualized by 1 hour, scanning must continue for four hours or until the gallbladder is visualized. when the gall bladder fails to appear within the first 60 minutes of imaging after th

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - technetium tc-99m sulfur colloid (unii: 556q0p6pb1) (technetium tc-99m sulfur colloid - unii:556q0p6pb1) - gelatin 18.1 mg in 10 ml - technetium tc 99m sulfur colloid injection is indicated: in adults, to assist in the:  in adults and pediatric patients, for imaging: none risk summary limited available data with technetium tc 99m sulfur colloid injection use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; technetium tc 99m crosses the placenta (see data) . animal reproduction studies have not been conducted with technetium tc 99m sulfur colloid injection. all radiopharmaceuticals, including technetium tc 99m sulfur colloid injection, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. if considering technetium tc 99m sulfur colloid injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. the estimated background risk of major birth def

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - technetium tc-99m pyrophosphate (unii: 5l76i61h2b) (technetium tc-99m pyrophosphate - unii:5l76i61h2b) - sodium pyrophosphate 12 mg in 10 ml - technetium tc 99m pyrophosphate injection is a bone imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction. kit for the preparation of technetium tc 99m pyrophosphate injection is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. when reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of sodium pertechnetate tc 99m injection, approximately 76% of the injected radioactivity remains in the blood pool. none known.

United States - English - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - technetium tc-99m medronate (unii: x89xv46r07) (technetium tc-99m medronate - unii:x89xv46r07) - medronic acid 20 mg in 10 ml - technetium tc 99m medronate injection may be used as a bone imaging agent to delineate areas of altered osteogenesis. none known.

United States - English - NLM (National Library of Medicine)

navidea biopharmaceuticals, inc. - technetium tc-99m tilmanocept (unii: 8ihi69pqtc) (technetium tc-99m tilmanocept - unii:8ihi69pqtc) - tilmanocept 250 ug - lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for: - lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management. - guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma. none. pregnancy category c there are no adequate or well-controlled studies of lymphoseek in pregnant women. additionally, animal reproduction studies have not been conducted with technetium tc 99m tilmanocept. however, all radiopharmaceuticals, including lymphoseek, have a potential to cause fetal harm. lymphoseek should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. it is not known whether technetium tc 99m tilmanocept is present in human milk.  based on the half-life of technetiu