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

memorial sloan kettering 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. 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 a

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

essential isotopes llc - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 300 mci in 1 ml - fludeoxyglucose f18 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 d

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

uihc-p e t imaging 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 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 a

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

pharmalogic south carolina, llc - 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 diagnoses 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 ventriclar 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 a pregnant woman; administer fludeoxyglucose f 18 injection only if clearly needed. it is not known whether fludeoxyglucose f 18 injection is excreted in human milk. consider alternative diagnostic tests in women who are breast-feeding. use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if fludeoxyglucose f 18 injection is administered to a woman who is breast-feeding. 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..

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

the feinstein institute for medical research - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 400 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 fludeoxyglucose 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.

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

hot shots nm, llc dba midwest positron technology, lc - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 500 mci in 1 ml - fludeoxyglucose f18 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 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 i

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

brigham and women`s hospital, inc., the - 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 8.1 pregnancy 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

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

mayo clinic - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 240 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 pregnancy category c animal reproduction studies have not been conducted with fludeoxyglucose f 18 injection usp. it is also not known whether fludeoxyglucose f 18 injection usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. consider alternative diagnostic tests in a pregnant woman; administer fludeoxyglucose f 18 injection usp only if clearly needed. it is not known whether fludeoxyglucose f 18 injection usp is excreted in human milk. consider alternative diagnostic tests in women who are breast-feeding. use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if fludeoxyglucose f 18 injection usp is administered to a woman who is breast-feeding. the safety and effectiveness of fludeoxyglucose f 18 injection usp 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 usp have not been established in pediatric patients.

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

mips cyclotron & radiochemistry facility - 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 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 a pregnant woman; administer fludeoxyglucose f 18 injection only if clearly needed. it is not known whether fludeoxyglucose f 18 injection is excreted in human milk. consider alternative diagnostic tests in women who are breast-feeding. use alternatives to breast feeding (e.g., stored breast milk or infant formula) for at least 10 half-lives of radioactive decay, if fludeoxyglucose f 18 injection is administered to a woman who is breast-feeding. 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.

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

university of california, los angeles - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 40 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 a p