European Union - English - EMA (European Medicines Agency)

advanced accelerator applications - l-arginine hydrochloride, l-lysine hydrochloride - radiation injuries - detoxifying agents for antineoplastic treatment - lysakare is indicated for reduction of renal radiation exposure during peptide-receptor radionuclide therapy (prrt) with lutetium (177lu) oxodotreotide in adults.

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)

advanced accelerator applications usa, inc - lutetium oxodotreotide lu-177 (unii: ae221im3bb) (lutetium oxodotreotide lu-177 - unii:ae221im3bb) - lutetium oxodotreotide lu-177 10 mci in 1 ml - lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (gep-nets), including foregut, midgut, and hindgut neuroendocrine tumors in adults. none. risk summary based on its mechanism of action, lutathera can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on lutathera use in pregnant women. no animal studies using lutetium lu 177 dotatate have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, radioactive emissions, including those from lutathera, can cause fetal harm. advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. risk summary there are no data on the presence of lutetium lu 177 dotatate in human milk, or its effects on the breastfed child or

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

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

advanced accelerator applications usa, inc - lutetium lu-177 vipivotide tetraxetan (unii: g6uf363ecx) (lutetium lu-177 vipivotide tetraxetan - unii:g6uf363ecx) - pluvicto is indicated for the treatment of adult patients with prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with androgen receptor (ar) pathway inhibition and taxane-based chemotherapy. none. risk summary the safety and efficacy of pluvicto have not been established in females. based on its mechanism of action, pluvicto can cause fetal harm [see clinical pharmacology (12.1)] . there are no available data on pluvicto use in pregnant females. no animal studies using lutetium lu 177 vipivotide tetraxetan have been conducted to evaluate its effect on female reproduction and embryo-fetal development; however, all radiopharmaceuticals, including pluvicto, have the potential to cause fetal harm. risk summary the safety and efficacy of pluvicto have not been established in females. there are no data on the presence of lutetium lu 177 vipivotide tetraxetan in human milk or its effects on the breastfed child or on milk production. contraception males based on its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment with pluvicto and for 14 weeks after the last dose [see clinical pharmacology (12.1), nonclinical toxicology (13.1)] . infertility the recommended cumulative dose of 44.4 gbq of pluvicto results in a radiation absorbed dose to the testes within the range where pluvicto may cause temporary or permanent infertility. the safety and effectiveness of pluvicto in pediatric patients have not been established. of the 529 patients who received at least one dose of pluvicto plus bsoc in the vision study, 387 patients (73%) were 65 years or older and 143 patients (27%) were 75 years or older. no overall differences in effectiveness were observed between patients ≥ 75 years of age and younger patients. serious adverse reactions occurred in 11% of patients ≥ 75 years of age and in 11% of younger patients. grade ≥ 3 adverse reactions occurred in 40% of patients ≥ 75 years of age and in 31% of younger patients. exposure of lutetium lu 177 vipivotide tetraxetan is expected to increase with the degree of renal impairment [see clinical pharmacology (12.3)] . no dose adjustment is recommended for patients with mild (baseline clcr 60 to 89 ml/min by cockcroft-gault) to moderate (clcr 30 to 59 ml/min) renal impairment; however, patients with mild or moderate renal impairment may be at greater risk of toxicity. frequently monitor renal function and adverse reactions in patients with mild to moderate renal impairment [see dosage and administration (2.4)] . the pharmacokinetics and safety of pluvicto have not been studied in patients with severe (clcr 15 to 29 ml/min) renal impairment or end-stage renal disease.

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

trigen laboratories, inc. - calcium carbonate (unii: h0g9379fgk) (calcium cation - unii:2m83c4r6zb), cholecalciferol (unii: 1c6v77qf41) (cholecalciferol - unii:1c6v77qf41), ascorbic acid (unii: pq6ck8pd0r) (ascorbic acid - unii:pq6ck8pd0r), folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8), pyridoxine hydrochloride (unii: 68y4cf58bv) (pyridoxine - unii:kv2jz1bi6z) - calcium carbonate 400 mg - advanced am/pm is indicated to provide calcium, essential fatty acids, folic acid and other vitamins and minerals for daily nutritional and health supplementation. advanced am/pm is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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

advanced first aid, inc. - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d), aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever/fever reducer with adjuvant uses: temporarily relieves minor aches and pains associated with: • headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

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

advanced first aid, inc. - bacitracin zinc (unii: 89y4m234es) (bacitracin - unii:58h6rwo52i) - first aid antibiotic uses: first aid to help prevent infection in: • minor cuts • scrapes • burns do not use : • in the eyes • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock • over large areas of the body • longer than 1 week unless directed by a doctor stop use and ask a doctor if: • before use in case of deep puncture wounds, animal bites or serious burns • if the condition persists or gets worse • if a rash or other allergic reaction develops

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

advanced first aid, inc. - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e) - pain reliever/fever reducer uses: temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis• muscle pain • pain and fever of colds • toothache • temporarily reduces fever