Australia - English - Department of Health (Therapeutic Goods Administration)

telix pharmaceuticals (anz) pty ltd - glu-urea-lys(ahx)-hbed-cc, quantity: 25 microgram - injection, diluent for - excipient ingredients: hydrochloric acid; sodium acetate; water for injections - illuccix, after radiolabelling with ga-68, is a radioactive diagnostic agent indicated for use with positron emission tomography (pet) imaging combined with computerised tomography (ct) in patients with prostate cancer: who are at risk of metastasis and who are suitable for initial definitive therapy; who have suspected recurrence based on elevated serum prostate specific antigen (psa) level.

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

bryant ranch prepack - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. - cardiogenic shock. - sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker. - known hypersensitivity to the drug or to any of its components, including iodine. risk summary available data from postmarketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. amiodarone and its metabolite, desethylamiodarone (dea), cross the placenta. untreated underlying arrhythmias, including ventricular arrh

Ireland - English - HPRA (Health Products Regulatory Authority)

ge healthcare limited - gallium (67 ga) citrate - solution for injection - 37 mbq/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

cis bio international - gallium (67 ga) citrate - solution for injection

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

hahnemann laboratories, inc. - gallium oxide (unii: 46f059v66a) (gallium oxide - unii:46f059v66a) -

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

hahnemann laboratories, inc. - gallium chloride (unii: 4y6gqd4915) (gallium cation - unii:f7k5mp217w) -

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

hahnemann laboratories, inc. - gallium phosphide (unii: 3j421f73dv) (gallium cation - unii:f7k5mp217w) -

Canada - English - Health Canada

novartis pharmaceuticals canada inc - gallium (68ga) gozetotide - kit - 25mcg - gallium (68ga) gozetotide 25mcg

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

advanced accelerator applications usa, inc - dotatate (unii: mrl3739g66) (dotatate gallium ga-68 - unii:9l17y0h71p) - dotatate 40 ug - netspot, after radiolabeling with gallium-68, is indicated for use with positron emission tomography (pet) for localization of somatostatin receptor positive neuroendocrine tumors (nets) in adult and pediatric patients. none. risk summary there are no studies with gallium ga 68 dotatate in pregnant women to inform any drug-associated risks; however, radioactive emissions, including those from gallium ga 68 dotatate, can cause fetal harm. animal reproduction studies have not been conducted with gallium ga 68 dotatate. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. risk summary there is no information on the presence of gallium ga 68 dotatate in human milk, the effect on the breastfed child, or the effect on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gallium ga 68 dotatate injection and a

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

advanced accelerator applications usa, inc - gozetotide (unii: 9ag41l3aoq) (gozetotide - unii:9ag41l3aoq) - locametz, after radiolabeling with gallium-68, is indicated for positron emission tomography (pet) of prostate-specific membrane antigen (psma)-positive lesions in men with prostate cancer: - with suspected metastasis who are candidates for initial definitive therapy. - with suspected recurrence based on elevated serum prostate-specific antigen (psa) level. - for selection of patients with metastatic prostate cancer, for whom lutetium lu 177 vipivotide tetraxetan psma-directed therapy is indicated. none. risk summary locametz is not indicated for use in females. there are no available data with gallium ga 68 gozetotide use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. all radiopharmaceuticals, including locametz, have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of radiation dose. animal reproduction studies have not been conducted with gallium ga 68 gozetotide. risk summar