Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

intermed medical ltd - alanine; arginine; aspartic acid; glucose monohydrate 5%; glutamic acid; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine - solution for infusion - 3.5 % - active: alanine arginine aspartic acid glucose monohydrate 5% glutamic acid glycine histidine isoleucine leucine lysine methionine phenylalanine proline serine threonine tryptophan tyrosine valine

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

intermed medical ltd - alanine; arginine; aspartic acid; glucose monohydrate 10%; glutamic acid; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine; valine - solution for infusion - 4.25 % - active: alanine arginine aspartic acid glucose monohydrate 10% glutamic acid glycine histidine isoleucine leucine lysine methionine phenylalanine proline serine threonine tryptophan tyrosine valine

Stati Uniti - inglese - NLM (National Library of Medicine)

b. braun medical inc. - histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), valine (unii - histidine 0.25 g in 100 ml - 5.4% nephramine® (essential amino acid injection) is indicated for adult and pediatric use, in conjunction with other measures, to provide nutritional support for uremic patients, particularly when oral nutrition is infeasible or impractical. see warnings, precautions, pediatric use , special precautions in pediatric patients , and dosage and administration . nephramine® is contraindicated in patients with severe, uncorrected electrolyte and acid-base imbalance, hyperammonemia, decreased (subcritical) circulating blood volume, inborn errors of amino acid metabolism, or hypersensitivity to one or more amino acids present in the solution.

Stati Uniti - inglese - NLM (National Library of Medicine)

b. braun medical inc. - isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), alanine (unii: of5 - isoleucine 0.69 g in 100 ml - parenteral nutrition with 10% freamine® iii (amino acid injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults and pediatric patients where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. dosage, route of administration, and concomitant infusion of nonprotein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. see warnings, precautions, pediatric use , and dosage and administration. central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, or those requiring long-term

Stati Uniti - inglese - NLM (National Library of Medicine)

b. braun medical inc. - isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), alanine (unii: of5 - isoleucine 0.76 g in 100 ml - parenteral nutrition with 6.9% freamine hbc® (amino acid injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. see dosage and administration . central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, or those requiring long-term parenteral nutrition. for moderately catabolic or deplet

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - alanine;  ; arginine;  ; glucose; glycine;  ; histidine;  ; isoleucine;  ; leucine;  ; lysine;  ; methionine;  ; phenylalanine;  ; proline;  ; threonine;  ; tryptophan;  ; tyrosine;  ; valine;   - solution for infusion - 8 % - active: alanine   arginine   glucose glycine   histidine   isoleucine   leucine   lysine   methionine   phenylalanine   proline   threonine   tryptophan   tyrosine   valine  

Nuova Zelanda - inglese - Medsafe (Medicines Safety Authority)

baxter healthcare ltd - alanine;  ; arginine;  ; glucose; glycine;  ; histidine;  ; isoleucine;  ; leucine;  ; lysine;  ; methionine;  ; phenylalanine;  ; proline;  ; threonine;  ; tryptophan;  ; tyrosine;  ; valine;   - solution for infusion - 10 % - active: alanine   arginine   glucose glycine   histidine   isoleucine   leucine   lysine   methionine   phenylalanine   proline   threonine   tryptophan   tyrosine   valine  

Stati Uniti - inglese - NLM (National Library of Medicine)

baxter healthcare corporation - leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), lysine (unii: k3z4f929h6) (lysine - unii:k3z4f929h6), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx - leucine 201 mg in 100 ml - clinimix e is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. clinimix e may be used to treat negative nitrogen balance in patients. there are no adequate or well-controlled studies in pregnant women with clinimix e. additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. it is not known whether clinimix e can cause fetal harm when administered to a pregnant woman. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. however, the estimated background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. disease-associated maternal and/or embryo-fetal risk based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutriti

Stati Uniti - inglese - NLM (National Library of Medicine)

baxter healthcare corporation - leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), lysine (unii: k3z4f929h6) (lysine - unii:k3z4f929h6), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), tryptophan (unii: 8duh1n11bx - leucine 201 mg in 100 ml - clinimix is indicated as a source of calories and protein for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. clinimix may be used to treat negative nitrogen balance in patients. the use of clinimix is contraindicated in: risk summary there are no adequate or well-controlled studies in pregnant women with clinimix. additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. it is not known whether clinimix can cause fetal harm when administered to a pregnant woman. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. however, the estimated background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. clinical considerations disease-associated maternal and/or embryo-fetal risk based on clinical practice guidelines, parenteral nutrition sh

Stati Uniti - inglese - NLM (National Library of Medicine)

baxter healthcare corporation - valine (unii: hg18b9yrs7) (valine - unii:hg18b9yrs7), lysine acetate (unii: ttl6g7liwz) (lysine - unii:k3z4f929h6), histidine (unii: 4qd397987e) (histidine - unii:4qd397987e), isoleucine (unii: 04y7590d77) (isoleucine - unii:04y7590d77), leucine (unii: gmw67qnf9c) (leucine - unii:gmw67qnf9c), phenylalanine (unii: 47e5o17y3r) (phenylalanine - unii:47e5o17y3r), threonine (unii: 2zd004190s) (threonine - unii:2zd004190s), methionine (unii: ae28f7pnpl) (methionine - unii:ae28f7pnpl), tryptophan (unii: 8duh1n11bx) (tryptophan - unii:8duh1n11bx), alanine (unii: of5p57n2zx) (alanine - unii:of5p57n2zx), glycine (unii: te7660xo1c) (glycine - unii:te7660xo1c), arginine (unii: 94zla3w45f) (arginine - unii:94zla3w45f), proline (unii: 9dlq4ciu6v) (proline - unii:9dlq4ciu6v), glutamic acid (unii: 3kx376gy7l) (glutamic acid - unii:3kx376gy7l), serine (unii: 452vly9402) (serine - unii:452vly9402), aspartic acid (unii: 30kyc7miai) (aspartic acid - unii:30kyc7miai), tyrosine (unii: 42hk56048u) (tyrosine - unii:42hk56048u) - valine 1.44 g in 100 ml - prosol is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. prosol may be used to treat negative nitrogen balance in patients. the use of prosol is contraindicated in: risk summary limited published data with injectable amino acids solutions, including prosol in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. however, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see clinical considerations]. animal reproduction studies have not been conducted with injectable amino acids solutions, including prosol. the 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. however, the background risk in the u.s. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. clinical considerations disease-associated maternal and/or embryo-fetal risk severe malnutrition in pregnant women is associated with preterm delivery, low birth weight, intrauterine growth restriction, congenital malformations and perinatal mortality. parenteral nutrition should be considered if a pregnant woman’s nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary there are no data available to assess the presence of injectable amino acids, including prosol in human milk, the effects of prosol on the breastfed infant or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of prosol to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for prosol and any potential adverse effects on the breastfed child from prosol or from the underlying maternal condition. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects [see dosage and administration (2.7)]. plasma electrolyte concentrations should be closely monitored in the pediatric patients who may have impaired ability to regulate fluids and electrolytes. hyperammonemia is of special significance in infants (birth to two years). this reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. it is essential that blood ammonia be measured frequently in infants [see warnings and precautions (5.7)]. because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with prosol may be at risk of aluminum toxicity [see warnings and precautions (5.8)]. patients, including pediatric patients, may be at risk for pnald [see warnings and precautions (5.9)]. clinical studies with prosol have not been performed to determine whether subjects aged 65 and over respond differently from other younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. in patients with impaired renal function, parenteral nutrition solutions containing prosol should be administered with caution. frequent clinical evaluation and laboratory tests to monitor renal function such as serum electrolytes (especially phosphate and potassium) and fluid balance should be conducted [see dosage and administration (2.6) , and warnings and precautions (5.10)]. in patients with impaired liver function, parenteral nutrition solutions containing prosol should be administered starting at the low end of the dosing range [see dosage and administration (2.5)]. frequent clinical evaluation and laboratory tests to monitor liver function such as bilirubin and liver function parameters should be conducted [see warnings and precautions (5.7) ].