Malta - English - Medicines Authority

ge healthcare as nycoveien 1, no-0485 oslo, norway - exametazime - powder for solution for injection - exametazime 0.5 mg - diagnostic radiopharmaceuticals

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

landauer radiopharmaceuticals pty ltd - tetrakis(2-methoxyisobutylisonitrile) copper(1) tetrafluoroborate, quantity: 1 mg - injection, powder for - excipient ingredients: stannous chloride dihydrate; cysteine hydrochloride monohydrate; sodium citrate dihydrate; mannitol; hydrochloric acid; sodium hydroxide - technetium [99m tc] 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 [99m tc] sestamibi is indicated as a second line diagnostic aid to assist in the evaluation of patients for whom mammography is inconclusive.

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

global medical solutions australia pty limited t/a radpharm scientific - sodium oxidronate, quantity: 3.15 mg - injection, powder for - excipient ingredients: sodium chloride; stannous chloride dihydrate; dilute hydrochloric acid; gentisic acid; sodium hydroxide - technetium [99m tc] sodium oxidronate is a diagnostic skeletal imaging agent to demonstrate areas of altered osteogenesis in adult patients.

Malta - English - Medicines Authority

ge healthcare limited - exametazime - powder for solution for injection - exametazime 0.5 mg - diagnostic radiopharmaceuticals

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

ge healthcare australia pty ltd - exametazime, quantity: 0.5 mg - injection, powder for - excipient ingredients: sodium chloride; stannous chloride dihydrate - for use in the preparation of technetium tc 99m exametazime for intravenous administration in specialised units for scintigraphic localisation of seizure foci in patients with temporal lobe epilepsy.

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

global medical solutions australia pty limited - sodium pertechnetate(99mtc), quantity: 18.5 gbq - injection, solution - excipient ingredients: water for injections; sodium chloride - technetium [99mtc] generator is used for the preparation of sodium pertechnetate 99m tc injection. sodium pertechnetate 99mtc is used as an agent for: brain imaging, thyroid imaging, salivary gland imaging, blood pool imaging.

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)

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.

Israel - English - Ministry of Health

isorad ltd, israel - molybdate (containing mo-99) - radio-pharma generator - molybdate (containing mo-99) 400 mg - technetium (99m-tc) compounds - diagnostic agent for iv injection producer of tc-99 for imaging of different organs.

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

australian nuclear science and technology organisation t/a ansto - sodium pertechnetate(99mtc), quantity: 370 gbq - injection - excipient ingredients: water for injections; sodium chloride - sodium pertechnetate [99mtc] is used for scintigraphy, principally of the brain and thyroid. it can also be used to prepare various technetium-99m labelled injections for selective organ imaging especially of the liver, lung, bone and kidney.