미국 - 영어 - NLM (National Library of Medicine)

the johns hopkins university - ammonia n-13 (unii: 9oqo0e343z) (ammonia n-13 - unii:9oqo0e343z) - ammonia n-13 37.5 mci in 1 ml - ammonia n 13 injection usp is indicated for diagnostic positron emission tomography (pet) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. none pregnancy category c animal reproduction studies have not been conducted with ammonia n 13 injection. it is also not known whether ammonia n 13 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ammonia n 13 injection should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for radiation exposure to nursing infants from ammonia n 13 injection, use alternative infant nutrition sources (e.g. stored breast milk or infant formula) for 2 hours (>10 half-lives of radioactive decay for n 13 isotope) after administration of the drug or avoid use of the drug, taking in

미국 - 영어 - NLM (National Library of Medicine)

the regents of the university of michigan - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f 18 injection is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none. risk summary - data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. however, published studies that describe fludeoxyglucose f 18 injection use in pregnant women have not identified a risk of drug-associated major birth defects, miscarriage, or adverse maternal or fetal outcomes. if considering fludeoxyglucose f 18 injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from fludeoxyglucose f 18 injection 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 are 2-4% and 15-20%, respectively. data human data data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placental barrier and visualization of radioactivity throughout the body of the fetus. the estimated fetal absorbed radiation dose from the maximum labeled dose (370 mbq) of fludeoxyglucose f 18 was 10mgy with first trimester exposure to pet alone and 20mgy with first trimester exposure to pet/ct scan combination. long-term adverse radiation effects to a child exposed to fludeoyxglucose f 18 injection in utero are unknown. no adverse fetal effects or radiation-related risks have been identified for diagnostic procedures involving less than 50mgy, which represents less than 20mgy fetal doses. risk summary a published case report and case series show the presence of fludeoxyglucose f 18 injection in human milk following administration. there are no data on the effects of fludeoxyglucose f 18 injection on the breastfed infant or the effects on milk production. exposure of fludeoxyglucose f 18 injection to a breastfed 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 fludeoxyglucose f 18 injection, any potential adverse effects on the breastfed child from fludeoxyglucose f 18 injection or from the underlying maternal condition. clinical considerations to decrease radiation exposure to the breastfed infant, advise a lactating woman to pump and discard breastmilk and avoid close (breast) contact with the infant for at least 9 hours after the administration of fludeoxyglucose f 18 injection. the safety and effectiveness of fludeoxyglucose f 18 injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. in pediatric patients with epilepsy, the recommended dose is 2.6 mci. the optimal dose adjustment on the basis of body size or weight has not been determined. in the oncology or cardiology settings, the safety and effectiveness of fludeoxyglucose f 18 injection have not been established in pediatric patients.

미국 - 영어 - NLM (National Library of Medicine)

the university of texas md anderson cancer center - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f18 injection is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none risk summary data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.

미국 - 영어 - NLM (National Library of Medicine)

washington university school of medicine - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f 18 injection usp is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none. risk summary - data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiatio

미국 - 영어 - NLM (National Library of Medicine)

the university of utah dba cyclotron radiochemistry lab huntsman cancer institute - sodium fluoride f-18 (unii: 9l75099x6r) (fluoride ion f-18 - unii:4m4we5n2ge) - fluoride ion f-18 200 mci in 1 ml - sodium fluoride f 18 injection, usp is indicated for diagnostic positron emission tomography (pet) imaging of bone to define areas of altered osteogenic activity. none. pregnancy category c any radiopharmaceutical including sodium fluoride f 18 injection has a potential to cause fetal harm. the likelihood of fetal harm depends on the stage of fetal development, and the radionuclide dose. animal reproductive and developmental toxicity studies have not been conducted with sodium fluoride f 18 injection. prior to the administration of sodium fluoride f 18 injection to women of childbearing potential, assess for presence of pregnancy. sodium fluoride f 18 injection should be given to a pregnant woman only if clearly needed. it is not known whether sodium fluoride f 18 injection is excreted into human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of sodi

미국 - 영어 - NLM (National Library of Medicine)

the university of utah dba cyclotron radiochemistry lab / huntsman cancer institute - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f-18 injection, usp is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none risk summary data from published case series and case reports describe fludeoxyglucose f 18 injection crossing the placenta with uptake by the fetus (see data). all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation

미국 - 영어 - NLM (National Library of Medicine)

trustees of the university of pennsylvania - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 200 mci in 1 ml - fludeoxyglucose f18 injection is indicated for positron emission tomography (pet) imaging in the following settings: for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none. pregnancy category c. animal reproduction studies have not been conducted with fludeoxyglucose f 18 injection. it is also not known whether fludeoxyglucose f 18 injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. consider alternative diagnostic tests in

미국 - 영어 - NLM (National Library of Medicine)

duke university school of medicine, carolinas cord blood bank - human cord blood hematopoietic progenitor cell (unii: xu53vk93mc) (human cord blood hematopoietic progenitor cell - unii:xu53vk93mc) - human cord blood hematopoietic progenitor cell 900000000 in 25 ml - ducord, hpc (hematopoietic progenitor cell), cord blood, is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. the risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells. none. risk summary there are no data with ducord use in pregnant women to inform a product-associated risk. animal reproduction studies have not been conducted with ducord. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in

미국 - 영어 - NLM (National Library of Medicine)

clinimmune labs, university of colorado blood bank - human cord blood hematopoietic progenitor cell (unii: xu53vk93mc) (human cord blood hematopoietic progenitor cell - unii:xu53vk93mc) - human cord blood hematopoietic progenitor cell 500000000 in 30 ml - hpc (hematopoietic progenitor cells), cord blood is an allogeneic cord blood hematopoietic progenitor cell therapy indicated for use in unrelated donor hematopoietic progenitor stem cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment. the risk benefit assessment for an individual patient depends on the patient characteristics, including disease, stage, risk factors, and specific manifestations of the disease, on characteristics of the graft, and on other available treatments or types of hematopoietic progenitor cells. hpc, cord blood is contraindicated in patients with known hypersensitivity to dimethyl sulfoxide (dmso), dextran 40 or plasma proteins. [see description (11) and dosage and administration (2.2)] pregnancy category c. animal reproduction studies have not been conducted with hpc, cord

미국 - 영어 - NLM (National Library of Medicine)

the university of texas md anderson cancer center - ammonia n-13 (unii: 9oqo0e343z) (ammonia n-13 - unii:9oqo0e343z) - ammonia n-13 37.5 mci in 1 ml