Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

jubilant hollisterstier general partnership - technetium tc-99m sestamibi (unii: 971z4w1s09) (technetium tc-99m sestamibi - unii:971z4w1s09) - tetrakis(2-methoxyisobutylisocyanide)copper(i) tetrafluoroborate 1 mg in 10 ml

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

jubilant draximage inc., dba jubilant radiopharma - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - exametazime 0.5 mg - drax exametazime is indicated for leukocyte (white blood cell) labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease. none. risk summary limited available data with technetium tc 99m exametazime use in pregnant women are insufficient to inform a drug associated risk for major birth defects and miscarriage. technetium tc 99m exametazime is transferred across the placenta [see data] . animal reproduction studies with technetium tc 99m exametazime have not been conducted. however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering technetium tc 99m exametazime administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from technetium tc 99m exametazime and the gestational timing of exposure. the estimated background risk of major birth defects and miscarriage for

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

northstar medical radioisotopes, llc - technetium tc-99m sodium pertechnetate (unii: a0730cx801) (technetium tc-99m pertechnetate - unii:ppp8783iq1) - molybdenum mo-99 6 ci in 6 ci - the radiogenix system is a technetium tc-99m generator used to produce sterile, non-pyrogenic sodium pertechnetate tc 99m injection. sodium pertechnetate tc 99m injection is indicated for use in the preparation of fda-approved diagnostic radiopharmaceuticals. sodium pertechnetate tc 99m injection is also indicated in: adults for : - thyroid imaging - salivary gland imaging - urinary bladder imaging (direct isotopic cystography) for detection of vesicoureteral reflux - nasolacrimal drainage system imaging (dacryoscintigraphy) pediatric patients for: - thyroid imaging - urinary bladder imaging (direct isotopic cystography) for the detection of vesicoureteral reflux. none. 8.1 pregnancy risk summary there are no available data with sodium pertechnetate tc-99m use in pregnant women to inform any drug-associated risks of developmental outcomes. animal reproductive studies have not been conducted with sodium pertechnetate tc-99m. all radiopharmaceuticals, including sodium pertechnetate tc-99m, have the potential to

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

cardinal health 414, llc - technetium tc-99m medronate (unii: x89xv46r07) (technetium tc-99m medronate - unii:x89xv46r07) - technetium tc 99m medronate may be used as a bone imaging agent to delineate areas of altered osteogenesis. none known.

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

lantheus mi australia pty ltd - bicisate dihydrochloride -

Austria - germană - AGES (Agentur für Gesundheit und Ernährungssicherheit)

lantheus eu limited - bicisat dihydrochlorid - [99mtc]technetiumbicisa

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

medi-physics inc. dba ge healthcare. - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - exametazime 0.5 mg in 5 ml - technetium tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. tc99m exametazime 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: 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. % bottom of saline strip – % bottom of mek strip (= % lipophilic exametazime complex) % top of saline strip (= % pertechnetate) % bottom of whatman no. 1 paper strip (= % reduced-hydrolyzed-tc) a radiochemical purity of >80% may be expected provided the measurement has been carried out within 4 hours of reconstitution for stabilized ceretec and 30 minutes for ceretec used for wbc labeling. 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.

Belgia - olandeză - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

monrol europe s.r.l. - technetium-tc 99m-natriumpertechnetaat (tc-99m) 8,3 gbq - 33,9 gbq; natriummolybdaat (mo-99) 10 gbq - 40 gbq - radionuclide generator - 10-40 gbq - natriummolybdaat (mo-99); technetium-tc 99m-natriumpertechnetaat (tc-99m) - technetium (99mtc) pertechnetate

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

curium us llc - technetium tc-99m sodium pertechnetate (unii: a0730cx801) (technetium tc-99m pertechnetate - unii:ppp8783iq1) - molybdenum mo-99 1 ci - the ultra-technekow™ v4 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 is used in adults as an agent for: thyroid imaging salivary gland imaging urinary bladder imaging (direct isotopic cystography) for detection of vesico-ureteral reflux nasolacrimal drainage system imaging (dacryoscintigraphy) sodium pertechnetate tc 99m is used in pediatric patients as an agent for: thyroid imaging urinary bladder imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux none.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

curium us llc - technetium tc-99m sodium pertechnetate (unii: a0730cx801) (technetium tc-99m pertechnetate - unii:ppp8783iq1) - molybdenum mo-99 1 ci - the ultra-technekow dte 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 is used in adults as an agent for:         thyroid imaging          salivary gland imaging urinary bladder imaging (direct isotopic cystography) for detection of vesico-ureteral reflux         nasolacrimal drainage system imaging (dacryoscintigraphy) sodium pertechnetate tc 99m is used in pediatric patients as an agent for:         thyroid imaging         urinary bladder imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux none. see indications and usage and dosage and administration sections. also see the description of additional risk under warnings .