Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride; glucose as monohydrate; lactic acid as sodium; magnesium chloride; sodium chloride - solution for peritoneal dialysis - calcium chloride 0.2573 g/l; sodium chloride 5.786 g/l; glucose as monohydrate 25 g/l; lactic acid as sodium 3.925 g/l; magnesium chloride 0.1017 g/l - combinations of electrolytes - combinations of electrolytes - for use in patients with end-stage (decompensated) chronic renal failure of any origin being maintained on peritoneal dialysis.

Israel - English - Ministry of Health

fresenius medical care israel p.b., ltd. - calcium chloride dihydrate; calcium chloride dihydrate; glucose monohydrate; glucose monohydrate; magnesium chloride hexahydrate; magnesium chloride hexahydrate; sodium chloride; sodium chloride; sodium hydrogen carbonate; sodium hydrogen carbonate - solution for peritoneal dialysis - sodium chloride 11.57 g/l; calcium chloride dihydrate 0.5145 g/l; magnesium chloride hexahydrate 0.2033 g/l; glucose monohydrate 25.0 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2573 g/l; sodium hydrogen carbonate 2.940 g/l; sodium chloride 5.786 g/l; sodium hydrogen carbonate 5.880 g/l; glucose monohydrate 50.00 g/l - combinations of electrolytes - combinations of electrolytes - end-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

Israel - English - Ministry of Health

fresenius medical care israel p.b., ltd. - calcium chloride dihydrate; calcium chloride dihydrate; glucose as monohydrate; glucose monohydrate; magnesium chloride hexahydrate; magnesium chloride hexahydrate; sodium chloride; sodium chloride; sodium hydrogen carbonate; sodium hydrogen carbonate - solution for peritoneal dialysis - sodium chloride 11.57 g/l; calcium chloride dihydrate 0.5145 g/l; magnesium chloride hexahydrate 0.2033 g/l; glucose as monohydrate 93.50 g/l; glucose monohydrate 46.75 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2573 g/l; sodium hydrogen carbonate 2.940 g/l; sodium chloride 5.786 g/l; sodium hydrogen carbonate 5.880 g/l - combinations of electrolytes - combinations of electrolytes - end-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride dihydrate; glucose as monohydrate; magnesium chloride hexahydrate; sodium carbonate hydrogen; sodium chloride - solution for heamodialysis/haemofiltration - sodium chloride 6.136 g/l; calcium chloride dihydrate 0.2205 g/l; sodium carbonate hydrogen 2.940 g/l; glucose as monohydrate 1 g/l; magnesium chloride hexahydrate 0.1017 g/l - combinations of electrolytes - combinations of electrolytes - multibic potassium-free is indicated for intravenous use as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration.for use in patients - with acute kidney injury requiring continuous renal replacement therapy: continuous haemodialysis, haemofiltration or haemodiafiltration treatments. - with chronic kidney disease in whom a transient treatment is indicated, e.g. during the stay on an intensive care unit.- when continuous renal replacement therapy is indicated as part of the treatment of an intoxication with water soluble, filterable/dialyzable toxins.multibic potassium-free is indicated in adults.

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride dihydrate; glucose as monohydrate; magnesium chloride hexahydrate; potassium chloride; sodium carbonate hydrogen; sodium chloride - solution for heamodialysis/haemofiltration - calcium chloride dihydrate 0.2205 g/l; glucose as monohydrate 1 g/l; magnesium chloride hexahydrate 0.1017 g/l; potassium chloride 0.2237 g/l; sodium carbonate hydrogen 2.940 g/l; sodium chloride 6.136 g/l - combinations of electrolytes - combinations of electrolytes - multibic 3 mmol/l potassium is indicated for intravenous use as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration.for use in patients - with acute kidney injury requiring continuous renal replacement therapy: continuous haemodialysis, haemofiltration or haemodiafiltration treatments. - with chronic kidney disease in whom a transient treatment is indicated, e.g. during the stay on an intensive care unit.- when continuous renal replacement therapy is indicated as part of the treatment of an intoxication with water soluble, filterable/dialyzable toxins.multibic 3 mmol/l potassium is indicated in adults.

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride dihydrate; glucose as monohydrate; magnesium chloride hexahydrate; potassium chloride; sodium carbonate hydrogen; sodium chloride - solution for heamodialysis/haemofiltration - glucose as monohydrate 1 g/l; magnesium chloride hexahydrate 0.1017 g/l; potassium chloride 0.2982 g/l; calcium chloride dihydrate 0.2205 g/l; sodium carbonate hydrogen 2.940 g/l; sodium chloride 6.136 g/l - combinations of electrolytes - combinations of electrolytes - multibic 4 mmol/l potassium is indicated for intravenous use as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration.for use in patients - with acute kidney injury requiring continuous renal replacement therapy: continuous haemodialysis, haemofiltration or haemodiafiltration treatments. - with chronic kidney disease in whom a transient treatment is indicated, e.g. during the stay on an intensive care unit.- when continuous renal replacement therapy is indicated as part of the treatment of an intoxication with water soluble, filterable/dialyzable toxins.multibic 4 mmol/l potassium is indicated in adults.

Israel - English - Ministry of Health

fresenius medical care israel p.b. ltd - calcium chloride dihydrate; glucose as monohydrate; magnesium chloride hexahydrate; potassium chloride; sodium carbonate hydrogen; sodium chloride - solution for heamodialysis/haemofiltration - sodium carbonate hydrogen 2.940 g/l; glucose as monohydrate 1 g/l; potassium chloride 0.1491 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2205 g/l; sodium chloride 6.136 g/l - electrolyte solutions - multibic 2 mmol/l potassium is indicated for intravenous use as substitution solution in haemofiltration and haemodiafiltration, and as dialysis solution in haemodialysis and haemodiafiltration.for use in patients - with acute kidney injury requiring continuous renal replacement therapy: continuous haemodialysis, haemofiltration or haemodiafiltration treatments. - with chronic kidney disease in whom a transient treatment is indicated, e.g. during the stay on an intensive care unit.- when continuous renal replacement therapy is indicated as part of the treatment of an intoxication with water soluble, filterable/dialyzable toxins.multibic 2 mmol/l potassium is indicated in adults.

Israel - English - Ministry of Health

fresenius medical care israel p.b., ltd. - calcium chloride dihydrate; calcium chloride dihydrate; glucose monohydrate; glucose monohydrate; magnesium chloride hexahydrate; magnesium chloride hexahydrate; sodium chloride; sodium chloride; sodium hydrogen carbonate; sodium hydrogen carbonate - solution for peritoneal dialysis - sodium chloride 11.57 g/l; calcium chloride dihydrate 0.5145 g/l; magnesium chloride hexahydrate 0.2033 g/l; sodium chloride 5.786 g/l; glucose monohydrate 33.0 g/l; glucose monohydrate 16.5 g/l; magnesium chloride hexahydrate 0.1017 g/l; calcium chloride dihydrate 0.2573 g/l; sodium hydrogen carbonate 2.940 g/l; sodium hydrogen carbonate 5.880 g/l - combinations of electrolytes - end-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

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

fresenius kabi usa, llc - sincalide (unii: m03giq7z6p) (sincalide - unii:m03giq7z6p) - sincalide for injection is indicated in adults to: - to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; - to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; - to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. sincalide for injection is contraindicated in patients with: - a history of hypersensitivity to sulfites or sincalide. serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see warnings and precautions (5.1), adverse reactions (6)] . - intestinal obstruction. risk summary based on limited human data and mechanism of action, sincalide may cause preterm labor or spontaneous abortion [see warnings and precautions (5.4)]. available data with sincalide for injection are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal embryo-fetal development studies in which sincalide was administered to hamsters and rats during the period of organogenesis, no effects were seen at doses comparable to the maximum recommended clinical dose on a mg/kg basis. however, in a prenatal development study in which rats were administered sincalide during organogenesis through parturition, decreased weight gain and developmental delays were observed at a dose 122 times higher than the maximum recommended human dose based on body surface area. 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 is 2 to 4% and 15 to 20%, respectively. data animal data there were no effects on embryo-fetal development in hamsters when sincalide was administered subcutaneously at 250 or 750 ng/kg during organogenesis (gestation days 7 to 13) at doses up to 0.8 times the maximum recommended dose of 120 ng/kg on a body surface area basis. no effects on embryo-fetal development were observed in sprague-dawley rats at subcutaneous doses of 250, 450, or 750 ng/kg from gestation days 6 to16, representing 1.0 time the maximum recommended human dose on a body surface area basis. in a separate study at a higher dose of 90 mcg/kg administered subcutaneously to cfy rats from gestation day 10 through parturition (representing 122 times the maximum recommended human dose on a body surface area basis), offspring showed decreased growth, behavioral changes, and developmental delays. risk summary there are no data regarding the presence of sincalide in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for sincalide for injection and any potential adverse effect on the breastfed infant from sincalide for injection or from the underlying condition. the safety and effectiveness in pediatric patients have not been established. clinical studies of sincalide for injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

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

fresenius medical care australia pty ltd - 34999 - tubing set, dialysis/haemodialysis - fresenius bloodlines are intended for use in the extracorporeal purification of blood