Canada - English - Health Canada

laboratoires charton laboratories - magnesium pidolate - powder - 1.5g - magnesium pidolate 1.5g - minerals

New Zealand - English - Ministry for Primary Industries

elanco new zealand - potassium glycerophosphate; cobalt (ii) sulphate; sodium glycerophosphate; magnesium glycerophosphate; ferric glycerophosphate; magnesium pidolate; ethylenediamine dihydroiodide; acetic acid; choline chloride; propylene glycol; calcium glycerophosphate - potassium glycerophosphate 0.07 g/litre; cobalt (ii) sulphate 1.1 g/litre; sodium glycerophosphate 0.04 g/litre; magnesium glycerophosphate 0.03 g/litre; ferric glycerophosphate 0.03 g/litre; magnesium pidolate 20 g/litre; ethylenediamine dihydroiodide 0.01 g/litre; acetic acid 0.39 g/litre; choline chloride 20.6 g/litre; propylene glycol 828.8 g/litre; calcium glycerophosphate 0.14 g/litre - oral nutrient/electrolyte

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

lange sas - zinc pidolate (unii: c32pq86dh4) (zinc pidolate - unii:c32pq86dh4), salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz), iris germanica var. florentina root (unii: m30xo5x4xd) (iris germanica var. florentina root - unii:m30xo5x4xd) - - purifying with an astingent activity, - anti-inflammatory, - antiseptic

Singapore - English - HSA (Health Sciences Authority)

quantum technologies global pte. ltd. - sodium iodide na131i, solution - capsule - sodium iodide na131i, solution 37-5500 mbq

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

merck sharp & dohme llc - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip) - ertugliflozin 5 mg - steglatro® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)] . - hypersensitivity to ertugliflozin or any excipient in steglatro, reactions such as angioedema have occurred [see adverse reactions (6.2)]. risk summary based on animal data showing adverse renal effects, steglatro is not recommended during the second and third trimesters of pregnancy. the limited available data with steglatro in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and t

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

merck sharp & dohme llc - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), sitagliptin phosphate (unii: ts63ew8x6f) (sitagliptin - unii:qfp0p1dv7z) - ertugliflozin 5 mg - steglujan® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)]. - has not been studied in patients with a history of pancreatitis. it is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using steglujan [see warnings and precautions (5.2)] . - patients with severe renal impairment (<30 ml/min/1.73 m2 ), end-stage renal disease (esrd), or on dialysis [see warnings and precautions (5.4) and use in specific populations (8.6)] . - hypersensitivity to sitagliptin, ertugliflozin, or any excipient, in steglujan, reactions such as anaphylaxis or angioedema have occurred [see warnings and precautions (5.11) and adverse reactions (6.2)]. risk summary based on animal data showing adverse renal effects, from ertugliflozin, steglujan is

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

merck sharp & dohme llc - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - ertugliflozin 2.5 mg - segluromet® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.2)]. - hypersensitivity to ertugliflozin, metformin, or any excipient in segluromet, reactions such as angioedema or anaphylaxis have occurred [see adverse reactions (6.2)]. - patients with severe renal impairment (egfr less than 30 ml/min/1.73 m2 ), end stage-renal disease (esrd), or on dialysis [see use in specific populations (8.6)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary based on animal data showing adverse renal effects, from ertugliflozin, segluromet is not recommended during the second and third trimesters of pregnancy. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage r

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

a-s medication solutions - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip) - steglatro® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)] . - hypersensitivity to ertugliflozin or any excipient in steglatro, reactions such as angioedema have occurred [see adverse reactions (6.2)]. risk summary based on animal data showing adverse renal effects, steglatro is not recommended during the second and third trimesters of pregnancy. the limited available data with steglatro in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. doses approximately 13 times the maximum clinical dose caused renal pelvic and tubule dilatations and renal mineralization that were not fully reversible. there was no evidence of fetal harm in rats or rabbits at exposures of ertugliflozin approximately 300 times higher than the maximal clinical dose of 15 mg/day when administered during organogenesis (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data when ertugliflozin was orally administered to juvenile rats from pnd 21 to pnd 90, increased kidney weight, renal tubule and renal pelvis dilatation, and renal mineralization occurred at doses greater than or equal to 5 mg/kg (13-fold human exposures, based on auc). these effects occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development, and did not fully reverse within a 1-month recovery period. in embryo-fetal development studies, ertugliflozin (50, 100 and 250 mg/kg/day) was administered orally to rats on gestation days 6 to 17 and to rabbits on gestation days 7 to 19. ertugliflozin did not adversely affect developmental outcomes in rats and rabbits at maternal exposures that were approximately 300 times the human exposure at the maximum clinical dose of 15 mg/day, based on auc. a maternally toxic dose (250 mg/kg/day) in rats (707 times the clinical dose), was associated with reduced fetal viability, and a higher incidence of a visceral malformation (membranous ventricular septal defect). in the pre- and post-natal development study in pregnant rats, ertugliflozin was administered to the dams from gestation day 6 through lactation day 21 (weaning). decreased post-natal growth (weight gain) was observed at maternal doses ≥100 mg/kg/day (greater than or equal to 331 times the human exposure at the maximum clinical dose of 15 mg/day, based on auc). risk summary there is no information regarding the presence of steglatro in human milk, the effects on the breastfed infant, or the effects on milk production. ertugliflozin is present in the milk of lactating rats (see data) . since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of steglatro is not recommended while breastfeeding. data the lacteal excretion of radiolabeled ertugliflozin in lactating rats was evaluated 10 to 12 days after parturition. ertugliflozin derived radioactivity exposure in milk and plasma were similar, with a milk/plasma ratio of 1.07, based on auc. juvenile rats directly exposed to steglatro during a developmental period corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations). safety and effectiveness of steglatro in pediatric patients under 18 years of age have not been established. no dosage adjustment of steglatro is recommended based on age. in steglatro clinical trials, a total of 876 (25.7%) patients treated with steglatro were 65 years and older, and 152 (4.5%) patients treated with steglatro were 75 years and older. patients 65 years and older had a higher incidence of adverse reactions related to volume depletion compared to younger patients; events were reported in 1.1%, 2.2%, and 2.6% of patients treated with comparator, steglatro 5 mg, and steglatro 15 mg, respectively [see warnings and precautions (5.3) and adverse reactions (6.1)] . in vertis cv, a total of 2780 (50.5%) patients treated with steglatro were 65 years and older, and 595 (10.8%) patients treated with steglatro were 75 years and older. safety and efficacy were generally similar for patients age 65 years and older compared to patients younger than 65. a 26-week placebo-controlled study of 313 patients with stage 3 chronic kidney disease (egfr ≥30 to less than 60 ml/min/1.73 m2 ) treated with steglatro did not demonstrate improvement in glycemic control. in the vertis cv study, there were 1370 patients (25%) with an egfr ≥90 ml/min/1.73 m2 , 2929 patients (53%) with an egfr of ≥60 to less than 90 ml/min/1.73 m2 , 879 patients (16%) with an egfr of ≥45 to less than 60 ml/min/1.73 m2 , and 299 patients (5%) with egfr of 30 to <45 ml/min/1.73 m2 treated with steglatro. similar effects on glycemic control at week 18 were observed in patients treated with steglatro in each egfr subgroup and also in the overall patient population. no dosage adjustment is needed in patients with egfr ≥45 ml/min/1.73 m2 . no dosage adjustment of steglatro is necessary in patients with mild or moderate hepatic impairment. ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population [see clinical pharmacology (12.3)] .

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

a-s medication solutions - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip) - steglatro® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use - not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see warnings and precautions (5.1)] . - hypersensitivity to ertugliflozin or any excipient in steglatro, reactions such as angioedema have occurred [see adverse reactions (6.2)]. risk summary based on animal data showing adverse renal effects, steglatro is not recommended during the second and third trimesters of pregnancy. the limited available data with steglatro in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . in animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human pregnancy. doses approximately 13 times the maximum clinical dose caused renal pelvic and tubule dilatations and renal mineralization that were not fully reversible. there was no evidence of fetal harm in rats or rabbits at exposures of ertugliflozin approximately 300 times higher than the maximal clinical dose of 15 mg/day when administered during organogenesis (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data animal data when ertugliflozin was orally administered to juvenile rats from pnd 21 to pnd 90, increased kidney weight, renal tubule and renal pelvis dilatation, and renal mineralization occurred at doses greater than or equal to 5 mg/kg (13-fold human exposures, based on auc). these effects occurred with drug exposure during periods of renal development in rats that correspond to the late second and third trimester of human renal development, and did not fully reverse within a 1-month recovery period. in embryo-fetal development studies, ertugliflozin (50, 100 and 250 mg/kg/day) was administered orally to rats on gestation days 6 to 17 and to rabbits on gestation days 7 to 19. ertugliflozin did not adversely affect developmental outcomes in rats and rabbits at maternal exposures that were approximately 300 times the human exposure at the maximum clinical dose of 15 mg/day, based on auc. a maternally toxic dose (250 mg/kg/day) in rats (707 times the clinical dose), was associated with reduced fetal viability, and a higher incidence of a visceral malformation (membranous ventricular septal defect). in the pre- and post-natal development study in pregnant rats, ertugliflozin was administered to the dams from gestation day 6 through lactation day 21 (weaning). decreased post-natal growth (weight gain) was observed at maternal doses ≥100 mg/kg/day (greater than or equal to 331 times the human exposure at the maximum clinical dose of 15 mg/day, based on auc). risk summary there is no information regarding the presence of steglatro in human milk, the effects on the breastfed infant, or the effects on milk production. ertugliflozin is present in the milk of lactating rats (see data) . since human kidney maturation occurs in utero and during the first 2 years of life when lactational exposure may occur, there may be risk to the developing human kidney. because of the potential for serious adverse reactions in a breastfed infant, advise women that the use of steglatro is not recommended while breastfeeding. data the lacteal excretion of radiolabeled ertugliflozin in lactating rats was evaluated 10 to 12 days after parturition. ertugliflozin derived radioactivity exposure in milk and plasma were similar, with a milk/plasma ratio of 1.07, based on auc. juvenile rats directly exposed to steglatro during a developmental period corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations). safety and effectiveness of steglatro in pediatric patients under 18 years of age have not been established. no dosage adjustment of steglatro is recommended based on age. in steglatro clinical trials, a total of 876 (25.7%) patients treated with steglatro were 65 years and older, and 152 (4.5%) patients treated with steglatro were 75 years and older. patients 65 years and older had a higher incidence of adverse reactions related to volume depletion compared to younger patients; events were reported in 1.1%, 2.2%, and 2.6% of patients treated with comparator, steglatro 5 mg, and steglatro 15 mg, respectively [see warnings and precautions (5.3) and adverse reactions (6.1)] . in vertis cv, a total of 2780 (50.5%) patients treated with steglatro were 65 years and older, and 595 (10.8%) patients treated with steglatro were 75 years and older. safety and efficacy were generally similar for patients age 65 years and older compared to patients younger than 65. a 26-week placebo-controlled study of 313 patients with stage 3 chronic kidney disease (egfr ≥30 to less than 60 ml/min/1.73 m2 ) treated with steglatro did not demonstrate improvement in glycemic control. in the vertis cv study, there were 1370 patients (25%) with an egfr ≥90 ml/min/1.73 m2 , 2929 patients (53%) with an egfr of ≥60 to less than 90 ml/min/1.73 m2 , 879 patients (16%) with an egfr of ≥45 to less than 60 ml/min/1.73 m2 , and 299 patients (5%) with egfr of 30 to <45 ml/min/1.73 m2 treated with steglatro. similar effects on glycemic control at week 18 were observed in patients treated with steglatro in each egfr subgroup and also in the overall patient population. no dosage adjustment is needed in patients with egfr ≥45 ml/min/1.73 m2 . no dosage adjustment of steglatro is necessary in patients with mild or moderate hepatic impairment. ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population [see clinical pharmacology (12.3)] .

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

a-s medication solutions - ertugliflozin pidolate (unii: mlu731k321) (ertugliflozin - unii:6c282481ip), metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - segluromet® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use not recommended in patients with type 1 diabetes mellitus. it may increase the risk of diabetic ketoacidosis in these patients [see warnings and precautions (5.2)]. - hypersensitivity to ertugliflozin, metformin, or any excipient in segluromet, reactions such as angioedema or anaphylaxis have occurred [see adverse reactions (6.2)]. - patients with severe renal impairment (egfr less than 30 ml/min/1.73 m2 ), end stage-renal disease (esrd), or on dialysis [see use in specific populations (8.6)] . - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary based on animal data showing adverse renal effects, from ertugliflozin, segluromet is not recommended during the second and third trimesters of pregnancy. published studies with metformin use during pregnancy have not reported a clear association with metformin and ma