European Union - English - EMA (European Medicines Agency)

advanced accelerator applications - edotreotide - neuroendocrine tumors; radionuclide imaging - diagnostic radiopharmaceuticals - this medicinal product is for diagnostic use only.after radiolabelling with gallium (68ga) chloride solution, the solution of gallium (68ga) edotreotide obtained is indicated for positron emission tomography (pet) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (gep-net) for localizing primary tumours and their metastases.

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

uihc – p e t imaging center - edotreotide gallium ga-68 (unii: y68179sy2l) (edotreotide gallium ga-68 - unii:y68179sy2l) - ga 68 dotatoc injection is indicated for use with positron emission tomography (pet) for the localization of somatostatin receptor positive neuroendocrine tumors (nets) in adult and pediatric patients. none risk summary there are no available data on the use of ga 68 dotatoc injection in pregnant women to identify a risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with ga 68 dotatoc. however, all radiopharmaceuticals, including ga 68 dotatoc injection have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. if considering ga 68 dotatoc injection administration to a pregnant woman, inform the patient of the potential for adverse pregnancy outcomes based on the radiation dose from ga 68 dotatoc injection and the gestational timing of exposure. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregn

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

fresenius kabi usa, llc - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration) . in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials p

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

fresenius kabi usa, llc - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration) . in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trial

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

mylan institutional llc - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration). in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials pe

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

wockhardt limited - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone and igf-i (somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of growth hormone and igf-i (somatomedin c) levels (see dosage and administration). in patients with acromegaly, octreotide acetate reduces growth hormone to within normal ranges in 50% of patients and reduces igf-i (somatomedin c) to within normal ranges in 50%-60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate to reduce blood levels of growth hormone and igf-i (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with octre

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

wockhardt usa llc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone and igf-i (somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of growth hormone and igf-i (somatomedin c) levels (see dosage and administration). in patients with acromegaly, octreotide acetate reduces growth hormone to within normal ranges in 50% of patients and reduces igf-i (somatomedin c) to within normal ranges in 50%-60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate to reduce blood levels of growth hormone and igf-i (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with octre

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

hikma pharmaceuticals usa inc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration ). in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested. improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials p

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

teva parenteral medicines, inc. - octreotide acetate (unii: 75r0u2568i) (octreotide - unii:rwm8ccw8gp) - octreotide 50 ug in 1 ml - octreotide acetate injection is indicated to reduce blood levels of growth hormone (gh) and insulin growth factor-1 (igf-1; somatomedin c) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. the goal is to achieve normalization of gh and igf-1 (somatomedin c) levels (see dosage and administration ). in patients with acromegaly, octreotide acetate injection reduces gh to within normal ranges in 50% of patients and reduces igf-1 (somatomedin c) to within normal ranges in 50% to 60% of patients. since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of gh and igf-1 (somatomedin c) offers potential benefit before the effects of irradiation are manifested.  improvement in clinical signs and symptoms, or reduction in tumor size or rate of growth, were not shown in clinical trials