Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

jubilant draximage inc., dba jubilant radiopharma - 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 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 to 4% and 15 to 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 10 mgy with first trimester exposure to pet alone and 20 mgy 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 50 mgy, which represents less than 20 mgy 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.

Malta - Englisch - Medicines Authority

curium austria gmbh grazer strasse 18 a-8071 hausmanstaetten , austria - solution for injection - fludeoxyglucose 1 gbq/ml - diagnostic radiopharmaceuticals

Malta - Englisch - Medicines Authority

curium austria gmbh grazer strasse 18 a-8071 hausmanstaetten , austria - solution for injection - fludeoxyglucose 1 gbq/ml - diagnostic radiopharmaceuticals

Kanada - Englisch - Health Canada

thunder bay regional health sciences centre - fludeoxyglucose 18f - solution - 0.5gbq - fludeoxyglucose 18f 0.5gbq - roentgenography

Kanada - Englisch - Health Canada

thunder bay regional health sciences centre - fludeoxyglucose 18f - solution - 0.5gbq - fludeoxyglucose 18f 0.5gbq - roentgenography

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

hamamatsu/queen’s pet imaging center, llc - fludeoxyglucose f-18 (unii: 0z5b2cjx4d) (fludeoxyglucose f-18 - unii:0z5b2cjx4d) - fludeoxyglucose f-18 100 mci in 1 ml - fludeoxyglucose f 18 injection, usp is indicated in positron emission tomography (pet) imaging 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. fludeoxyglucose f 18 injection, usp is indicated in positron emission tomography (pet) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function. fludeoxyglucose f 18 injection, usp is indicated in positron emission tomography (pet) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. none known

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

massachusetts general hospital - 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.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

wisconsin medical cyclotron llc - 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 f18 injection, usp. it is also not known whether fludeoxyglucose f18 injection, usp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. consider alternative diagnost

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

children's hospital 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 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

biomedical research foundation of northwest louisiana - 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 d