뉴질랜드 - 영어 - Medsafe (Medicines Safety Authority)

paragon care group new zealand limited - hetastarch 6% (molar substitution 0.7, av. mwt 480,000 daltons);  ; sodium chloride 0.9% - solution for infusion - active: hetastarch 6% (molar substitution 0.7, av. mwt 480,000 daltons)   sodium chloride 0.9% excipient: water for injection

미국 - 영어 - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea) - 6% hetastarch in 0.9% sodium chloride injection is indicated in the treatment of hypovolemia when plasma volume expansion is desired. it is not a substitute for blood or plasma. the adjunctive use of 6% hetastarch in 0.9% sodium chloride injection in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means. do not use hydroxyethyl starch (hes) products, including 6% hetastarch in 0.9% sodium chloride injection, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt). • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in patients with severe liver disease • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in patients with known hypersensitivity to hydroxyethyl starch • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in clinical conditions where volume overload is a potential problem (such as, congestive heart failure or renal disease with anuria or oliguria not related to hypovolemia). • do not use hes products, including 6% hetastarch in 0.9% sodium chloride injection, in patients with pre-existing coagulation or bleeding disorders 8.1 pregnancy hetastarch has been shown to have an embryocidal effect on new zealand rabbits when given intravenously over the entire organogenesis period in a daily dose 1/2 times the maximum recommended therapeutic human dose (1500 ml) and on bd rats when given intraperitoneally, from the 16th to the 21st day of pregnancy, in a daily dose 2.3 times the maximum recommended therapeutic human dose. when hetastarch was administered to new zealand rabbits, bd rats, and swiss mice with intravenous daily doses of 2 times, 1/3 times, and 1 times the maximum recommended therapeutic human dose respectively over several days during the period of gestation, no evidence of teratogenicity was evident. there are no adequate and well-controlled studies in pregnant women. 6% hetastarch in 0.9% sodium chloride injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 nursing mothers it is not known whether hetastarch is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when 6% hetastarch in 0.9% sodium chloride injection is administered to a nursing woman. 8.4 pediatric use the safety and effectiveness of hetastarch in pediatric patients have not been established. adequate, well-controlled clinical trials to establish the safety and effectiveness of 6% hetastarch in 0.9% sodium chloride injection in pediatric patients have not been conducted.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - potassium chloride, quantity: 0.3 g/l; sodium chloride, quantity: 6.02 g/l; hydroxyethyl starch 130/0.4, quantity: 60 g/l; magnesium chloride hexahydrate, quantity: 0.3 g/l; sodium acetate trihydrate, quantity: 4.63 g/l - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. the use of volulyte is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

미국 - 영어 - NLM (National Library of Medicine)

cardinal health - hetastarch (unii: 875y4127ea) (hetastarch - unii:875y4127ea) - hetastarch 6 g in 100 ml

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

fresenius kabi australia pty ltd - hydroxyethyl starch 130/0.4, quantity: 60 g/l; sodium chloride, quantity: 6.02 g/l; potassium chloride, quantity: 0.3 g/l; magnesium chloride hexahydrate, quantity: 0.3 g/l; sodium acetate trihydrate, quantity: 4.63 g/l - injection, intravenous infusion - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. the use of volulyte is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.

아일랜드 - 영어 - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - hetastarch sodium chloride - solution for infusion - 6 %w/v

그리스 - 그리스어 - Εθνικός Οργανισμός Φαρμάκων

fresenius kabi hellas ae (0000003822) Λεωφ. Μεσογείων 354, 153 41, Αγ. Παρασκευή, 153 41 - hydroxyethyl starch; sodium chloride - ΔΙΑΛΥΜΑ ΓΙΑ ΕΓΧΥΣΗ - 6%+0,9% (w/v) - ineof01242 hydroxyethyl starch 60.000000 g; 0007647145 sodium chloride 9.000000 g - hydroxyethylstarch

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

servier laboratories (aust) pty ltd - irinotecan hydrochloride trihydrate, quantity: 5 mg/ml - injection, concentrated - excipient ingredients: distearoylphosphatidylcholine; cholesterol; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; hepes; sodium chloride; water for injections; sucrosofate - onivyde is indicated:,? in combination with oxaliplatin and 5 fluorouracil (5 fu) and leucovorin (lv) for the first-line treatment of metastatic pancreatic adenocarcinoma.,? in combination with 5-fu and lv for the treatment of metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.

미국 - 영어 - NLM (National Library of Medicine)

general injectables & vaccines, inc - thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j) - thiamine hydrochloride 100 mg in 1 ml - thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in wernicke's encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. it is also indicated when giving iv dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be g

미국 - 영어 - NLM (National Library of Medicine)

mylan institutional llc - thiamine hydrochloride (unii: m572600e5p) (thiamine ion - unii:4abt0j945j) - thiamine hydrochloride 100 mg in 1 ml - thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. it is also indicated when giving iv dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be g