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`7. I declare that all statements made herein of my own knowledge are true
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`
`Christopher Butler
`
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`Exhibit A
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`Exhibit A
`
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`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&
`m=Hospira,%20Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.xml
`
`
`Eton Ex. 1010
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`5/1/2020
`
`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`
`
`
`You are here: HomeHome > Prescription(RX) DrugsPrescription(RX) Drugs > AA > Aminosyn
`Aminosyn (Hospira, Inc.)
`
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`
`Name: Aminosyn
`
`Manufacturer: Hospira, Inc.
`
`Category: Prescription Marketed Drugs
`
`AMINOSYN - isoleucine, leucine, lysine acetate, methionine,
`phenylalanine, threonine, tryptophan, valine, alanine,
`arginine, histidine, proline, serine, tyrosine and
`glycine injection, solution
`HOSPIRA, INC.
`----------
`
`®
`AMINOSYN
`A Crystalline Amino Acid Solution
`
`R only
`x
`
`DESCRIPTION
`®
`Aminosyn (a crystalline amino acid solution) is a sterile,
`nonpyrogenic solution for intravenous infusion. Five different
`
`formulations are available:
`
`Aminosyn Formulations
`Essential Amino Acids (mg/100 mL)
`Aminosyn
`3.5%5% 7% 8.5%10%
`Isoleucine
`252 360510620 720
`Leucine
`329 470660810 940
`Lysine (acetate)*252 360510624 720
`Methionine
`140 200280340 400
`Phenylalanine
`154 220310380 440
`Threonine
`182 260370460 520
`Tryptophan
`56
`80 120150 160
`Valine
`280 400560680 800
`
`* Amount cited is for Lysine alone and does not include the acetate salt.
`
`Nonessential Amino Acids (mg/100 mL)
`Aminosyn
`3.5%
`5%
`Alanine
`448
`640
`Arginine
`343
`490
`Histidine
`105
`150
`Proline
`300
`430
`Serine
`147
`210
`Tyrosine
`31
`44
`Glycine
`448
`640
`Aminosyn
`3.5%
`5%
`Electrolytes (mEq/Liter)
`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&m=Hospira, Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.… 1/9
`
`7%
`900
`690
`210
`610
`300
`44
`900
`7%
`
`8.5%
`1100
`850
`260
`750
`370
`44
`1100
`8.5%
`
`10%
`1280
`980
`300
`860
`420
`44
`1280
`10%
`
`Eton Ex. 1010
`5 of 13
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`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`5/1/2020
`a
`+
`7
`None
`None
`None
`None
`Sodium (Na )
`b
`b
`b
`b
`+
`None
`5.4
`5.4
`5.4
`5.4
`Potassium (K )
`c
`−
`None
`None
`None
`35
`None
`Chloride (Cl )
`2 3 2− d
`Acetate (C H O ) 46
`86
`105
`90
`148
`Protein Equivalent
`35
`50
`70
`85
`100
`(approx. grams/liter)
`Total Nitrogen
`(grams/liter)
`Osmolarity
`(mOsmol/liter calc.)
`pH and
`range
`
`e
`e
`e
`f
`e
`5.4 (4.5 − 6.0 )5.1 (4.5 − 6.0 )5.3 (4.5 − 6.0 )5.3 (4.5 − 6.0 )5.4 (4.5 − 6.0 )
`
`a
`+
` Includes 7 mEq Na /liter from the antioxidant, sodium hydrosulfite.
`b
`+
` Includes 5.4 mEq K /liter from the antioxidant, potassium metabisulfite.
`c
`Includes chloride from HCl added for processing and pH adjustment.
`d
`Includes acetate from acetic acid used in processing and from Lysine acetate.
` Adjusted with acetic acid.
` Adjusted with acetic acid and hydrochloric acid.
`The formulations contain the following added ingredients/100 mL:
`Aminosyn 5%, 7%, 8.5% and 10%
`Potassium metabisulfite added, 60 mg.
`Aminosyn 3.5%
`Sodium hydrosulfite added, 60 mg.
`The formulas for the individual amino acids present in Aminosyn (a crystalline amino acid solution) are
`as follows:
`
`e f
`
`Essential Amino Acids
`Isoleucine
`(C H NO )
`6 13
`2
`Leucine
`(C H NO )
`6 13
`2
`Lysine Acetate(C H N O • CH COOH)
`6 14 2 2
`3
`Methionine
`(C H NO S)
`5 11
`2
`Phenylalanine (C H NO )
`9 11
`2
`Threonine
`(C H NO )
`4 9
`3
`Tryptophan
`(C H N O )
`11 12 2 2
`Valine
`(C H NO )
`5 11
`2
`Nonessential Amino Acids
`Alanine
`(C H NO )
`3 7
`2
`Arginine
`(C H N O )
`6 14 4 2
`Histidine
`(C H N O )
`6 9 3 2
`Proline
`(C H NO )
`5 9
`2
`Serine
`(C H NO )
`3 7
`3
`Tyrosine
`(C H NO )
`9 11
`3
`Glycine
`(C H NO )
`2 5
`2
`
`CLINICAL PHARMACOLOGY
`Aminosyn provides crystalline amino acids to promote protein synthesis and wound healing, and to
`reduce the rate of endogenous protein catabolism. Aminosyn, given by central venous infusion in
`combination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat
`supplements, constitutes total parenteral nutrition (TPN). Aminosyn can also be administered by
`peripheral vein with dextrose and maintenance electrolytes. Intravenous fat emulsion may be
`substituted for part of the carbohydrate calories during either TPN or peripheral vein administration of
`Aminosyn.
`
`INDICATIONS AND USAGE
`Aminosyn infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the
`nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral
`nutrition cannot be tolerated, is undesirable, or inadequate.
`SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE
`ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS WITHOUT
`ELECTROLYTES.
`Aminosyn can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat
`emulsion as a source of nutritional support. This form of nutritional support can help to preserve
`protein and reduce catabolism in stress conditions where oral intake is inadequate.
`When administered with concentrated dextrose solutions with or without fat emulsions, Aminosyn is
`also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients
`where: (a) the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be
`used; (b) gastrointestinal absorption of protein is impaired; (c) metabolic requirements for protein are
`substantially increased as with extensive burns and (d) morbidity and mortality may be reduced by
`replacing amino acids lost from tissue breakdown, thereby preserving tissue reserves, as in acute
`renal failure.
`
`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&m=Hospira, Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.… 2/9
`
`5.5
`
`357
`
`7.86
`
`500
`
`11.00
`
`700
`
`13.4
`
`850
`
`15.72
`
`1000
`
`Eton Ex. 1010
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`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`5/1/2020
`CONTRAINDICATIONS
`This preparation should not be used in patients with hepatic coma or metabolic disorders involving
`impaired nitrogen utilization.
`
`WARNINGS
`Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in
`patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed
`periodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to
`rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein
`intake.
`Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino
`acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
`Administration of amino acid solutions in the presence of impaired renal function may augment an
`increasing BUN, as does any protein dietary component.
`Solutions containing sodium ion should be used with great care, if at all, in patients with congestive
`heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium
`retention.
`Solutions which contain potassium ion should be used with great care, if at all, in patients with
`hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
`Solutions containing acetate ion should be used with great care in patients with metabolic or
`respiratory alkalosis. Acetate should be administered with great care in those conditions in which there
`is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
`Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore,
`it is essential that blood ammonia levels be measured frequently in infants.
`Instances of asymptomatic hyperammonemia have been reported in patients without overt liver
`dysfunction. The mechanisms of this reaction are not clearly defined, but may involve genetic defects
`and immature or subclinically impaired liver function.
`Aminosyn can be infused simultaneously with fat emulsion by means of a Y-connector located near the
`infusion site using separate flow rate controls for each solution.
`Aminosyn 5%, 7%, 8.5% and 10% contain potassium metabisulfite; Aminosyn 3.5% contains sodium
`hydrosulfite, sulfites that may cause allergic-type reactions including anaphylactic symptoms and life-
`threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of
`sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more
`frequently in asthmatic than in nonasthmatic people.
`
`PRECAUTIONS
`Special care must be taken when administering glucose to provide calories in diabetic or prediabetic
`patients.
`Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential
`anabolic effects of amino acids infused with dextrose as part of a parenteral feeding regimen.
`Feeding regimens which include amino acids should be used with caution in patients with history of
`renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid
`accumulation.
`The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is
`not known at this time.
`Nitrogen intake should be carefully monitored in patients with impaired renal function.
`For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate
`exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an
`effective source of such calories. Such strongly hypertonic nutrient solutions should be administered
`through an indwelling intravenous catheter with the tip located in the superior vena cava.
`
`SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS
`ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD
`BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE
`AND ITS COMPLICATIONS.
`
`Central vein infusion (with added concentrated carbohydrate solutions) of amino acid solutions
`requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of
`complications. Attention must be given to solution preparation, administration and patient monitoring.
`IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL BASED ON CURRENT MEDICAL
`PRACTICES BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.
`SUMMARY HIGHLIGHTS OF COMPLICATIONS (consult current medical literature).
`1. Technical:
`The placement of a central venous catheter should be regarded as a surgical procedure. One
`should be fully acquainted with various techniques of catheter insertion. For details of technique
`and placement sites, consult the medical literature. X-ray is the best means of verifying catheter
`placement. Complications known to occur from the placement of central venous catheters are
`pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial
`plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air
`and catheter emboli.
`2. Septic:
`The constant risk of sepsis is present during administration of total parenteral nutrition. It is
`imperative that the preparation of the solution and the placement and care of catheters be
`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&m=Hospira, Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.… 3/9
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`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`5/1/2020
`accomplished under strict aseptic conditions.
`Solutions should ideally be prepared in the hospital pharmacy in a laminar flow hood using careful
`aseptic technique to avoid inadvertent touch contamination. Solutions should be used promptly
`after mixing. Storage should be under refrigeration and limited to a brief period of time, preferably
`less than 24 hours.
`Administration time for a single bottle and set should never exceed 24 hours.
`3. Metabolic:
`The following metabolic complications have been reported: Metabolic acidosis and alkalosis,
`hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar
`nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration,
`elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and hyperammonemia
`in children. Frequent evaluations are necessary especially during the first few days of therapy to
`prevent or minimize these complications.
`Administration of glucose at a rate exceeding the patient’s utilization rate may lead to
`hyperglycemia, coma and death.
`
`Pregnancy Category C.
`Animal reproduction studies have not been conducted with Aminosyn. It is not known whether
`Aminosyn can cause fetal harm when administered to a pregnant woman or can affect reproduction
`capacity. Aminosyn should be given to a pregnant woman only if clearly needed.
`
`Geriatric Use
`Clinical studies of Aminosyn have not been performed to determine whether patients over 65 years
`respond differently from younger subjects. Other reported clinical experience has not identified
`differences in responses between elderly and younger patients. In general, dose selection for elderly
`patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac
`function, and of concomitant disease or other drug therapy. This drug is known to be substantially
`excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with
`impaired renal function. Because elderly patients are more likely to have decreased renal function,
`care should be taken in dose selection, and it may be usefulto monitor renal functions.
`CLINICAL EVALUATION AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE
`ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING
`ADMINISTRATION. Do not withdraw venous blood for blood chemistries through the peripheral
`infusion site, as interference with estimations of nitrogen containing substances may occur. Blood
`studies should include glucose, urea nitrogen, serum electrolytes, ammonia, cholesterol, acid-base
`balance, serum proteins, kidney and liver function tests, osmolarity and hemogram. White blood count
`and blood cultures are to be determined if indicated. Urinary osmolality and glucose should be
`determined as necessary.
`
`ADVERSE REACTIONS
`Peripheral Infusions
`A 4.25 or 5% solution of amino acids (without additives) is slightly hypertonic. A 3.5% concentration of
`amino acids (without additives) is slightly hypertonic. Local reactions consisting of a warm sensation,
`erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous
`infusion of amino acids particularly if other substances, such as antibiotics, are also administered
`through the same site. In such cases the infusion site should be changed promptly to another vein.
`Use of large peripheral veins, inline filters, and slowing the rate of infusion may reduce the incidence of
`local venous irritation. Electrolyte additives should be spread throughout the day. Irritating additive
`medications may need to be injected at another venous site.
`Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino
`acid solutions.
`
`OVERDOSAGE
`In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate
`corrective measures. See WARNINGS and PRECAUTIONS.
`
`DOSAGE AND ADMINISTRATION
`The total daily dose of the solution depends on the daily protein requirements and on the patient’s
`metabolic and clinical response. In many patients, provision of adequate calories in the form of
`hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and
`glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be
`administered when hypertonic dextrose infusions are abruptly discontinued.
`Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
`administration, whenever solution and container permit.
`1. Peripheral Vein Nutritional Maintenance
`®
`Aminosyn 3.5% (a crystalline amino acid solution) together with dextrose in concentrations of 5%
`to 10% is suitable for administration by peripheral vein. This solution is not intended for central vein
`infusion since it does not contain adequate amounts of amino acids or electrolytes for
`administration with high concentrations of dextrose. Aminosyn 7%, 8.5% or 10% may be diluted
`with sterile water for injection or 5 to 10% Dextrose Injection to achieve a final amino acid
`concentration of 3.5, 4.25 or 5% for peripheral administration.
`For peripheral intravenous infusion, 1.0 to 1.5 g/kg/day of total amino acids will reduce protein
`catabolism. Infusion or ingestion of carbohydrate or lipid will not reduce the nitrogen sparing effect
`of intravenous amino acid infusions at this dose.
`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&m=Hospira, Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.… 4/9
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`

`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`5/1/2020
`As with all intravenous fluid therapy, the primary aim is to provide sufficient water to compensate for
`insensible, urinary and other (nasogastric suction, fistula drainage, diarrhea) fluid losses. Total fluid
`requirements, as well as electrolyte and acid-base needs, should be estimated and appropriately
`administered.
`For an amino acid solution of specified total concentration, the volume required to meet amino acid
`requirements per 24 hours can be calculated. After making an estimate of the total daily fluid
`(water) requirement, the balance of fluid needed beyond the volume of amino acid solution required
`can be provided either as a noncarbohydrate or a carbohydrate-containing electrolyte solution. I.V.
`lipid emulsion may be substituted for part of the carbohydrate containing solution. Vitamins and
`additional electrolytes as needed for maintenance or to correct imbalances may be added to the
`amino acid solution.
`If desired, only one-half of an estimated daily amino acid requirement of 1.5 g/kg can be given on
`the first day. Amino acids together with dextrose in concentrations of 5% to 10% infused into a
`peripheral vein can be continued while oral nutrition is impaired. However, if a patient is unable to
`take oral nourishment for a prolonged period of time, institution of total parenteral nutrition with
`exogenous calories should be considered.
`2. Central Vein Total Parenteral Nutrition
`For central vein infusion with concentrated dextrose solution, alone or with I.V. lipid, the total daily
`dose of the amino acid solution depends upon daily protein requirements and the patient’s
`metabolic and clinical response. The determination of nitrogen balance and accurate daily body
`weights, corrected for fluid balance, are probably the best means of assessing individual protein
`requirements.
`
`ADULTS
`Solutions containing 3.5 to 5% amino acids with 5 to 10% glucose may be coinfused with a fat
`emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion
`coadministration should be considered when prolonged parenteral nutrition is required in order to
`prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of
`EFAD in patients maintained on fat-free total parenteral nutrition.
`Aminosyn 5%, 7% (with or without electrolytes), 8.5% and 10% solutions should only be infused via a
`central vein when admixed with sufficient dextrose to provide full caloric requirements in patients who
`require prolonged total parenteral nutrition. I.V. lipid may be administered separately to provide part of
`the calories, if desired.
`Total parenteral nutrition (TPN) may be started with 10% dextrose added to the calculated daily
`requirement of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose content is gradually
`increased over the next few days to the estimated daily caloric need as the patient adapts to the
`increasing amounts of dextrose. Each gram of dextrose provides approximately 3.4 kcal. Each gram of
`fat provides 9 kcal.
`The average depleted major surgical patient with complications requires between 2500 and 4000 kcal
`and between 12 and 24 grams of nitrogen per day. An adult patient in an acceptable weight range with
`restricted activity who is not hypermetabolic, requires about 30 kcal/kg of body weight/day. Average
`daily adult fluid requirements are between 2500 and 3000 mL and may be much higher with losses
`from fistula drainage or severe burns. Typically, a hospitalized patient may lose 12 to 18 grams of
`nitrogen a day, and in severe trauma the daily loss may be 20 to 25 grams or more.
`Aminosyn solutions without electrolytes are intended for patients requiring individualized electrolyte
`therapy. Sodium, chloride, potassium, phosphate, calcium and magnesium are major electrolytes
`which should be added to Aminosyn as required.
`SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. Electrolytes may be added to
`the nutrient solution as indicated by the patient’s clinical condition and laboratory determinations of
`plasma values. Major electrolytes are sodium, chloride, potassium, phosphate, magnesium and
`calcium. Vitamins, including folic acid and vitamin K are required additives. The trace element
`supplements should be given when long-term parenteral nutrition is undertaken.
`Calcium and phosphorus are added to the solution as indicated. The usual dose of phosphate added
`to a liter of TPN solution (containing 25% dextrose) is 12 mM. This requirement is related to the
`carbohydrate calories delivered. Iron is added to the solution or given intramuscularly in depot form as
`indicated. Vitamin B , vitamin K and folic acid are given intramuscularly or added to the solution as
`12
`desired.
`Calcium and phosphate additives are potentially incompatible when added to the TPN admixture.
`However, if one additive is added to the amino acid bottle, and the other to the bottle of concentrated
`dextrose, and if the contents of both bottles are swirled before they are combined, then the likelihood
`of physical incompatibility is reduced.
`In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as
`the acetate or lactate salts to provide bicarbonate alternates.
`In adults, hypertonic mixtures of amino acids and dextrose may be safely administered by continuous
`infusion through a central venous catheter with the tip located in the vena cava. Typically, the 7%,
`8.5% or 10% solution is used in equal volume with 50% dextrose to provide an admixture containing
`3.5%, 4.25% or 5% amino acids and 25% dextrose.
`The rate of intravenous infusion initially should be 2 mL/min and may be increased gradually. If
`administration should fall behind schedule, no attempt to “catch up” to planned intake should be made.
`In addition to meeting protein needs, the rate of administration is governed by the patient’s glucose
`tolerance estimated by glucose levels in blood and urine.
`Aminosyn 10% solution, when mixed with an appropriate volume of concentrated dextrose, offers a
`higher concentration of calories and nitrogen per unit volume. This solution is indicated for patients
`
`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&m=Hospira, Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.… 5/9
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`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`5/1/2020
`requiring larger amounts of nitrogen than could otherwise be provided or where total fluid load must be
`kept to a minimum, for example, patients with renal failure.
`Provision of adequate calories in the form of hypertonic dextrose may require exogenous insulin to
`prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, do not abruptly discontinue
`administration of nutritional solutions.
`PEDIATRIC
`Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements
`of the infant and greater caloric requirements per kilogram. Amino acids are probably best
`administered in a 2.5% concentration. For most pediatric patients on intravenous nutrition, 2.5 grams
`amino acids/kg/day with dextrose alone or with I.V. lipid calories of 100 to 130 kcal/kg/day is
`recommended. In cases of malnutrition or stress, these requirements may be increased. It is
`acceptable in pediatrics to start with a nutritional solution of half strength at a rate of about 60 to 70
`mL/kg/day. Within 24 to 48 hours the volume and concentration of the solution can be increased until
`the full strength pediatric solution (amino acids and dextrose) is given at a rate of 125 to 150
`mL/kg/day.
`Supplemental electrolytes and vitamin additives should be administered as deemed necessary by
`careful monitoring of blood chemistries and nutritional status. Addition of iron is more critical in the
`infant than the adult because of the increasing red cell mass required for the growing infant. Serum
`lipids should be monitored for evidence of essential fatty acid deficiency in patients maintained on fat-
`free TPN. Bicarbonate should not be administered during infusion of the nutritional solution unless
`deemed absolutely necessary.
`To insure the precise delivery of the small volumes of fluid necessary for total parenteral nutrition in
`infants, accurately calibrated and reliable infusion systems should be used.
`A basic solution for pediatric use should contain 25 grams of amino acids and 200 to 250 grams of
`glucose per 1000 mL, administered from bottles containing 250 or 500 mL. Such a solution given at
`the rate of 145 mL/kg/day provides 130 kcal/kg/day.
`
`HOW SUPPLIED
`
`List No.Concentration Container (mL)
`2989
`Aminosyn 3.5%1000
`2990
`Aminosyn 5% 1000
`500
`250
`Aminosyn 7% 1000
`500
`Aminosyn 8.5%1000
`500
`Aminosyn 10% 1000*
`500
`
`2992
`
`5855
`
`2991
`
`® ®
`
`® ® ®
`
`*Provides sufficient volume to withdraw 1050 mL.
`Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from
`freezing. It is recommended that the product be stored at room temperature (25°C); however, brief
`exposure up to 40°C does not adversely affect the product. Avoid exposure to light.
`Rev: October, 2004
`
`©Hospira 2004EN-0642Printed in USA
`
`HOSPIRA, INC., LAKE FOREST, IL 60045 USA
`
`AMINOSYN
`isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine,
`proline, serine, tyrosine, and glycine injection, solution
`
`Product Information
`Product Type
`Route of Administration
`
`HUMAN PRESCRIPTION DRUG
`-
`INTRAVENOUS
`
`Item Code (Source)
`DEA Schedule
`
`l
`
`NDC:0409-2989
`-
`
`
`~
`
`-
`
`-
`
`-
`
`-
`
`INGREDIENTS
`"
`Strength
`Type
`Name (Active Moiety)
`I
`Isoleucine (Isoleucine)
`252 MILLIGRAM In 100 MILLILITER
`Active
`t
`Leucine (Leucine)
`329 MILLIGRAM In 100 MILLILITER
`Active
`Lysine acetate (Lysine)
`252 MILLIGRAM In 100 MILLILITER
`Active
`t
`1 - -
`r
`Methionine (Methionine)
`140 MILLIGRAM In 100 MILLILITER
`Active
`r--
`L
`Phenylalanine (Phenylalanine)
`154 MILLIGRAM In 100 MILLILITER
`Active
`Threonine (Threonine)
`182 MILLIGRAM In 100 MILLILITER
`Active
`-1-
`Tryptophan (Tryptophan)
`56 MILLIGRAM In 100 MILLILITER
`Active
`t
`Valine (Valine)
`280 MILLIGRAM In 100 MILLILITER
`Active
`Alanine (Alanine)
`448 MILLIGRAM In 100 MILLILITER
`Active
`t
`1 - -
`r
`Arginine (Arginine)
`343 MILLIGRAM In 100 MILLILITER
`Active
`r--
`L
`Histidine (Histidine)
`105 MILLIGRAM In 100 MILLILITER
`Active
`Proline (Proline)
`300 MILLIGRAM In 100 MILLILITER
`Active
`-1-
`Serine (Serine)
`147 MILLIGRAM In 100 MILLILITER
`Active
`t
`Tyrosine (Tyrosine)
`Active
`31 MILLIGRAM In 100 MILLILITER
`https://web.archive.org/web/20130831172706/http://www.drugsdb.eu/drug.php?d=Aminosyn&m=Hospira, Inc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D802.… 6/9
`
`~
`
`~
`
`~
`
`~
`
`~
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`5/1/2020
`Glycine (Glycine)
`-
`Sodium Hydrosulfite
`Acetic Acid
`
`AMINOSYN - isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, ty…
`Active
`448 MILLIGRAM In 100 MILLILITER
`Inactive
`60 MILLIGRAM In 100 MILLILITER
`-1-
`Inactive
`
`L
`
`L
`
`-
`
`Product Characteristics
`Color
`Shape
`Flavor
`Contains
`
`Score
`
`- i
`Size
`Imprint Code
`I
`
`
`
`I_
`
`-
`
`Packaging
`# Item Code
`1 0409-2989-05
`1
`
`Package Description
`6 BOTTLE In 1 CASE
`1000 mL (MILLILITER) In 1 BOTTLE, GLASS
`
`" r
`
`Multilevel Packaging
`contains a BOTTLE, GLASS
`This package is contained within the CASE (0409-2989-05)
`
`AMINOSYN
`isoleucine, leucine, lysine, m