Namibia - Inggris - Namibia Medicines Regulatory Council

adcock ingram critical care (pty) ltd - hydroxyethyl starch, sodium chloride - infusion - each 1000 ml of solution contains hydroxyethyl starch 60 g, sodium chloride 9 g

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

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

Amerika Serikat - Inggris - 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.

Selandia Baru - Inggris - Medsafe (Medicines Safety Authority)

paragon care group new zealand limited t/a rem systems - 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

Kenya - Inggris - Pharmacy and Poisons Board

pt sanbe farma jl. taman sari no. 10 bandung west java,indonesia - hydroxyethyl starch 130 infusion - infusion - starch/hes…30 g (molecular weight 130.000) (molar… - hydroxyethylstarch

Malaysia - Inggris - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

b.braun medical industries sdn bhd - malic acid; potassium chloride; sodium chloride; magnesium chloride hexahydrate.; calcium chloride dihydrate.; hydroxyethyl starch/hetastarch; sodium acetate trihydrate. -

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - poly(o-2-hydroxyethyl)starch, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, l-malic acid dab - solution for infusion - 60 mg/ml - blood substitutes and plasma protein fractions

Irlandia - Inggris - HPRA (Health Products Regulatory Authority)

b. braun melsungen ag - poly(o-2-hydroxyethyl)starch, sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, l-malic acid dab - solution for infusion - 60 mg/ml - blood substitutes and plasma protein fractions

Amerika Serikat - Inggris - NLM (National Library of Medicine)

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

Singapura - Inggris - HSA (Health Sciences Authority)

fresenius kabi (singapore) pte ltd - poly (o-2-hydroxyethyl) starch; sodium chloride - injection - 60 g/l - poly (o-2-hydroxyethyl) starch 60 g/l; sodium chloride 9 g/l