الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

fresenius kabi usa, llc - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6) ] risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations 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. clinical considerations disea

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - alanine; isoleucine; arginine; leucine; histidine; methionine; phenylalanine; serine; threonine; tryptophan; valine; medium chain triglycerides; glucose monohydrate; glycine; sodium glycerophosphate; fish oil; olive oil; taurine; tyrosine.; zinc sulphate.; magnesium sulphate.; soya bean oil.; lysine; proline,; calcium chloride.; potassium chloride.; sodium acetate. -

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - alanine; calcium chloride dihydrate; isoleucine; tyrosine; arginine; histidine; leucine__; methionine; phenylalanine; proline; serine; threonine; tryptophan; valine; lysine acetate; magnesium sulphate heptahydrate; medium chain triglycerides; soya bean oil; glycine; potassium chloride; sodium glycerophosphate, hydrated; sodium acetate trihydrate; glucose monohydrate; fish oil; olive oil; taurine; zinc sulphate heptahydrate -

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - bortezomib - multiple myeloma - antineoplastic agents - bortezomib as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.bortezomib in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.

ماليزيا - الإنجليزية - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

fresenius kabi malaysia sdn. bhd - alanine; isoleucine; arginine; leucine; methionine; phenylalanine; tryptophan; valine; lysine acetate; magnesium sulphate heptahydrate; glycine; glucose monohydrate; fish oil; olive oil; zinc sulphate heptahydrate; tyrosine.; medium chain triglycerides , ph. eur.; sodium acetate, trihydrate, ph. eur.; sodium glycerophosphate; soya bean oil refined; taurine.; serine,; proline,; threonine,; potassium chloride ph eur; histidine.; calcium chloride dihydrate ph. eur. -

الاتحاد الأوروبي - الإنجليزية - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - sugammadex sodium - neuromuscular blockade - all other therapeutic products - reversal of neuromuscular blockade induced by rocuronium or vecuronium in adults.for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

نيوزيلاندا - الإنجليزية - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - alanine 14 g/l;  ;  ; arginine 12 g/l;  ;  ; calcium chloride dihydrate 0.56 g/l (as dihydrate. equivalent to 0.74 g/l calcium chloride dihydrate);  ; glycine 11 g/l;  ;  ;  ; histidine 3 g/l;  ;  ;  ; isoleucine 5 g/l;  ;  ;  ; leucine 7.4 g/l;  ;  ;  ;  ; lysine acetate 9.3 g/l equivalent to l-lysine 6.6 g/l;  ;  ; magnesium sulfate 1.2 g/l (as heptahydrate. equivalent to 2.47 g/l magnesium sulphate heptahydrate);  ;  ; methionine 4.3 g/l;  ;  ; phenylalanine 5.1 g/l;  ;  ; potassium chloride 4.48 g/l;  ; proline 11.2 g/l;  ; serine 6.5 g/l;  ;  ;  ; sodium acetate trihydrate 3.4 g/l (as trihydrate. equivalent to sodium acetate trihydrate 5.62 g/l);  ;  ;  ; sodium glycerophosphate 4.18 g/l (as hydrate. amount added corrected for actual water content of substance);  ; taurine 1 g/l;  ; threonine 4.4 g/l;  ;  ;  ; tryptophan 2 g/l;  ;  ;  ; tyrosine 0.4 g/l;  ; valine 6.2 g/l;  ;  ;  ;  ; zinc sulfate 0.023 g/l (as heptahydrate. equivalent to zinc sulphate 0.0129 g);  ; glucose monohydrate 462 g/l equivalent to glucose (anhydrous) 420 g/l;  ;  ; fish oil 30 g/l; medium-chain triglycerides 60 g/l;  ; olive oil 50 g/l;  ; soya oil 60 g/l;   - emulsion for infusion - active: alanine 14 g/l     arginine 12 g/l     calcium chloride dihydrate 0.56 g/l (as dihydrate. equivalent to 0.74 g/l calcium chloride dihydrate)   glycine 11 g/l       histidine 3 g/l       isoleucine 5 g/l       leucine 7.4 g/l         lysine acetate 9.3 g/l equivalent to l-lysine 6.6 g/l     magnesium sulfate 1.2 g/l (as heptahydrate. equivalent to 2.47 g/l magnesium sulphate heptahydrate)     methionine 4.3 g/l     phenylalanine 5.1 g/l     potassium chloride 4.48 g/l   proline 11.2 g/l   serine 6.5 g/l       sodium acetate trihydrate 3.4 g/l (as trihydrate. equivalent to sodium acetate trihydrate 5.62 g/l)       sodium glycerophosphate 4.18 g/l (as hydrate. amount added corrected for actual water content of substance)   taurine 1 g/l   threonine 4.4 g/l       tryptophan 2 g/l       tyrosine 0.4 g/l   valine 6.2 g/l         zinc sulfate 0.023 g/l (as heptahydrate. equivalent to zinc sulphate 0.0129 g)   excipient: glacial acetic acid nitrogen water for injection active: glucose monohydrate 462 g/l equivalent to glucose (anhydrous) 420 g/l     excipient: hydrochloric acid nitrogen water for injection active: fish oil 30 g/l medium-chain triglycerides 60 g/l   olive oil 50 g/l   soya oil 60 g/l   excipient: dl-alpha tocopherol egg lecithin glycerol nitrogen sodium hydroxide sodium oleate water for injection - parenteral nutrition for adults and children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

fresenius kabi limited - soya bean oil, refined; calcium chloride dihydrate; methionine; potassium chloride; tryptophan; olive oil, refined; zinc sulphate heptahydrate; phenylalanine; triglycerides medium-chain; proline; isoleucine; magnesium sulfate heptahydrate; alanine; tyrosine; sodium acetate trihydrate; serine; sodium glycerophophate hydrate; arginine; glucose monohydrate; taurine; glycine; valine; lysine acetate; fish oil, rich in omega-3 acids; leucine; histidine - emulsion for infusion - unknown - solutions for parenteral nutrition; combinations

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - alanine; arginine ; glycine; histidine; isoleucine; leucine ; lysine acetate; methionine; phenylalanine; proline; serine; taurine; tryptophan; tyrosine; valine; calcium chloride dihydrate; sodium glycerophophate hydrate; magnesium sulfate heptahydrate; potassium chloride; sodium acetate trihydrate ; zinc sulphate heptahydrate; glucose monohydrate; soya bean oil, refined; triglycerides medium-chain ; olive oil, refined; fish oil, rich in omega-3 acids - emulsion for infusion - solutions for parenteral nutrition; combinations

أيرلندا - الإنجليزية - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - soya bean oil, refined ph. eur.; medium chain triglycerides; refined olive oil; fish oil, rich in omega-3 acids; isoleucine; leucine ; methionine; lysine acetate; phenylalanine; threonine; tryptophan; valine; arginine ; histidine; alanine; glycine; proline; serine; tyrosine; taurine; calcium chloride dihydrate; sodium glycerophophate hydrate; magnesium sulphate heptahydrate ; potassium chloride; sodium acetate trihydrate ; zinc sulphate heptahydrate; glucose monohydrate - emulsion for infusion - solutions for parenteral nutrition; combinations