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

anazaohealth corporation - exametazime (unii: g29272nckl) (exametazime - unii:g29272nckl) - exametazime 1 mg - exametazime is a diagnostic agent used as an adjunct in the detection of altered cerebral perfusion in stroke patients and is also indicated for white blood cell labeling as an adjunct in the localization of abdominal infections and inflammatory bowel disease there are no known contraindications for this preparation.

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)

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

United States - English - 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.

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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

radiopharmacy laboratory ltd. - exametazime 500 µg - kit for radiopharmaceutical preparation - 0,5 mg - exametazime 500 µg - technetium (99mtc) exametazime; v09ha02 technetium (99mtc) exametazime labelled cells

Malta - English - Medicines Authority

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

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

medi-physics, inc. dba ge healthcare - technetium tc-99m exametazime (unii: 3b744ag22n) (technetium tc-99m exametazime - unii:3b744ag22n) - ceretec, when reconstituted with technetium tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ceretec, when reconstituted with technetium tc 99m exametazime (with or without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for cerebral scintigraphy as an adjunct in the detection of altered regional cerebral perfusion in stroke. none risk summary limited available data with technetium tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks 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 the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data human data limited published literature describes tc 99m exametazime crossing the placental barrier and visualization of radioactivity in the fetal liver. no adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50 mgy, which represents less than 10 mgy fetal doses. risk summary there are limited data available in the scientific literature on the presence of technetium tc 99m exametazime in human milk. there are no data available regarding the effects of technetium tc 99m exametazime on the breastfed infant or on milk production. exposure of technetium tc 99m exametazime to a breast fed infant can be minimized by temporary discontinuation of breastfeeding [see clinical considerations ]. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ceretec and any potential adverse effects on the breastfed child from ceretec or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breast milk after the administration of technetium tc 99m exametazime injection or technetium tc 99m exametazime-labeled leukocytes for 12 to 24 hours, where the duration corresponds to the typical range of administered activity, 259 mbq to 925 mbq (7 mci to 25 mci). ceretec is indicated for use in pediatric patients from 2 to 17 years of age for leukocyte labelled scintigraphy and brain scintigraphy. the use of ceretec for leukocyte labelled scintigraphy and brain scintigraphy is supported by extrapolation from clinical effectiveness in adults. the safety and dosing recommendations are based on clinical experience. safety and effectiveness in pediatric patients less than 2 years of age have not been established. clinical studies of ceretec did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and radiation exposure may be greater in patients with impaired renal function. a reduction in administered tc 99m can be considered provided an adequate number of leukocytes are administered.

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

ge healthcare limited - exametazime - kit for radiopharmaceutical preparation - 500 microgram - technetium (99mtc) exametazime