AMINOSYN . isoleucine X + V
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`Name: Aminosyn
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`Manufacturer: Hospira, Inc.
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`Category: Prescription Marketed Drugs
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`ID
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`AUG
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`31
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`(cid:127)
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`• '"' .- '"' •~ '"' I(:" 0
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`U.S. :\ational Lihrar~
`of l\kdkim·
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`Prescription Marketed Drugs Alphabetically
`Al Bl CJ DJ El Fl GI HJ II JI Kl LI Ml NJ OJ Pl QJ RI
`SJ Tl UJ VI WI XI YI Zl 0-9
`
`Categories:
`Prescription1:RX) Drugs
`
`Over-the-counter (OTC) Drugs
`
`Homeopathic Drugs
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`Animal Drugs
`
`Feedback
`
`AMINOSYN - isoleucine, leucine, lysine acetate, methionine,
`phenylalanine, threonine, tryptophan, valine, alanine,
`arginine, histidine, proline, serine, tyrosine and
`glycine injection, solution
`HOSPIRA, INC.
`
`AMINO SYN®
`A Crystalline Amino Acid Solution
`
`Rx only
`
`DESCRIPTION
`minosyn® (a crystalline amino acid solution) is a sterile, nonpyrogenic solution for intravenous
`infusion. Five different formulations are available:
`
`minosyn Formulations
`Essential Amino Acids (mg/100 ml )
`minosyn
`3.5%5% 7% 8.5%10%
`lsoleucine
`252 360510620 720
`Leucine
`329 470660810 940
`Lysine (acetate)'252 360510624 720
`Methionine
`140 200280340 400
`Phenylalanine 154 220310380 440
`hreonine
`182 260370460 520
`ryptophan
`56 80 120150 160
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`AMINOSYN - isoleucine X + V
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`lhttp:llwww.drugsdb.eu/drug.php?d=Aminosyn&m==Hospira,%20lnc.&id=-2A72A8B8-A77C-49C6-3C8D-43B036720802.xml
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`Amount cited is for Lysine alone and does not include the acetate salt.
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`I
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`Nonessential Amino Acids (mg/100 ml)
`3.5%
`5%
`448
`640
`343
`490
`105
`150
`300
`430
`147
`210
`31
`44
`448
`640
`3.5%
`minosyn
`5%
`Electrolytes (mEq/Liter)
`odium (Na•)
`7a
`Potassium (K• )
`None
`hloride (Ci-)
`None
`cetate (C2H302- )d 46
`Protein Equivalent 35
`(approx. grams/liter)
`otal Nitrogen
`5.5
`(grams/liter)
`smolarity
`(mOsmol/liter calc.)
`pH and
`
`None
`5.4b
`None
`86
`50
`
`7.86
`
`7%
`900
`690
`210
`610
`300
`44
`900
`7%
`
`None
`5.4b
`None
`105
`70
`
`11.00
`
`8.5%
`1100
`850
`260
`750
`370
`44
`1100
`8.5%
`
`None
`5.4b
`35c
`90
`85
`
`13.4
`
`10%
`1280
`980
`300
`860
`420
`44
`1280
`10%
`
`None
`5.4b
`None
`148
`100
`
`15.72
`
`1000
`700
`850
`500
`357
`5.4 (4 5 - 6.0•)5.1 (4 5 - 6.0•)5.3 (4 5 - 6 o•)5.3 (4 5 - 6.01)5.4 (4.5 - 6.0•)
`
`Includes 7 mEq Na•/liter from the antioxidant, sodium hydrosulfite_
`Includes 5.4 mEq K•tliter from the antioxidant, potassium metabisulfite.
`Includes chloride from HCI added for processing and pH adjustment.
`Includes acetate from acetic acid used in processing and from Lysine acetate.
`Adjusted with acetic acid.
`Adjusted with acetic acid and hydrochloric acid.
`he formulations contain the following added ingredients/100 ml:
`minosyn 5%, 7%, 8.5% and 10%
`Potassium metabisulfite added, 60 mg.
`minosyn 3.5%
`odium hydrosulfite added, 60 mg.
`he formulas for the individual amino acids present in Aminosyn (a crystalline amino acid solution) are
`s follows:
`
`Essential Amino Acids
`lsoleucine
`(C6H13N02)
`Leucine
`(C6H13N02)
`Lysine Acetate(C6H14N202• CH3COOH)
`(C5H11N02S)
`Methionine
`Phenylalanine (C9H11N02)
`hreonine
`(C4H9N03)
`(C11H12N20 2)
`ryptophan
`aline
`(C5H11N02)
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`AMINOSYN - isoleucine X + v
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`Nonessential Amino Acids
`(C3H7N02)
`(C5H14N40 2)
`(C5H9N302)
`(C5H9N02)
`(C3H7N03)
`(C9H11N03)
`(C2H5N02)
`
`LINICAL PHARMACOLOGY
`minosyn 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
`ombination with concentrated dextrose, electrolytes, vitamins, trace metals, and ancillary fat
`upplements, constitutes total parenteral nutrition (TPN). Aminosyn can also be administered by
`peripheral vein wit h dextrose and maintenance electrolytes. Intravenous fat emulsion may be
`ubstituted for part of the carbohydrate calories d uring either TPN or peripheral vein administration of
`minosyn.
`
`minosyn infused with dextrose l>y 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, ora l
`nutrition cannot be tolerated, is undesirable, or inadequate.
`UPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPT ION OF THE
`TTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS W ITHOUT
`ELECTROLYTES.
`minosyn can be administered peripherally with d ilute (5 to 10%) dex1rose solution and IV. fat
`mulsion 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.
`hen administered with concentrated dextrose solutions with or without fat emulsions, A minosyn is
`lso indicated for central vein infusion to prevent or reverse negative nitrogen l>alance in patients
`here: (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) metal>olic requirements for protein are
`ubstantially increased as with ex1ensive burns and (d) morbidity and mortality may be reduced l>y
`replacing amino acids lost from tissue breakdown, therel>y preserving tissue reserves, as in acute
`renal failure.
`
`his preparation should not l>e used in patients w ith hepatic coma or metabolic d isorders involving
`impaired nitrogen utilization.
`
`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 l>e performed
`~eriodically and infusion discontinued if BUN levels exceed normal postprandial limits and continue to
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`AMINOSYN - isoleucine X I + v --------------
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`8 https;/ jweb.archive.orgjweb/20130831172706/http;/Www.drugsdb.eu/drug.php?d = Aminosyn&n
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`lhttp://www.drugsdb.eu/drug.php?d=Arninosyn&m=Hospira,%201nc.&id=2A72A8B8-A77C-49C6-3C8D-43B03672D8 02.xml
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`7 captures
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`1maKe.
`!Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amin o
`~cid imoalances, metaoolic alkalosis, prerenal az:otemia, 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
`~olutions containing sodium ion should oe used w ith great care, if at all, in patients with congestive
`heart failure, severe renal insufficiency and in clin ical states in which there exists edema with sodium
`retention.
`~olutions which contain potassium ion should oe used with great care, if at all, in patients with
`hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
`~olutions containing acetate ion should be used w it h great care in patients with metaoolic 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 oe measured frequently in infants.
`Instances of asymptomatic hyperammonemia have oeen reported in patients without overt liver
`~ysfunction. The mechanisms of this reaction are not clearly defined, out may involve genetic defects
`a nd immature or subclinically impaired liver function.
`Aminosyn can be infused simultaneously with fat emulsion oy means of a Y-connector located near the
`infusion site using separate flow rate controls for each solution.
`1/1.minosyn 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(cid:173)
`hreatening or less severe asthmatic episodes in certain susceptiole people. The overall prevalence of
`~ulfite sensitivity in the general population is unknown and prooably low. Sulfite sensitivity is seen
`more frequently in asthmatic than in nonasthmatic people.
`
`PRECAUTIONS
`S pecial care must oe taken when administering g lucose to provide calories in d iaoetic or prediabetic
`patients.
`Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential
`~naoolic effects of amino acids infused with dextrose as part of a parenteral feed ing regimen.
`Feeding regimens which include amino acids sho uld be used with caution in patients with history of
`renal d isease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid
`accumulation.
`lfhe 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
`" xogenous calories concurrently wit h the amino acids. Concentrated dextrose solutions are an
`»ffective source of such calories. Such strongly hypertonic nutrient solutions should be administered
`hrough 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 W ITH THIS TECHNIQUE
`AND ITS COMPLICATIONS.
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`~lh~ttp~1_Aw_ ,w_.d_rn~g~sd_b_.e_u_ld_ru~g~.p~hp~?_d=_A_m_;_no_• ~yn_&_m_=_Ho_s~p•_·r•~•%_ 2_0_ln_c_.&_;d_=2_A_7_2A_ 8_B_8_-A_7_7C_-_49_C_6_-3_C_8D_ -_43_B_0_3_67_2_D_80_2_.x_m_l -~I I~
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`entral vein infusion (wit h added concentrated ca rbohydrate solutions) of amino acid solutions
`requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of
`omplications. Attention must be given to solution preparation, administration and patient monitoring.
`IT IS ESSENTIAL THAT A CAREFULLY PREPA RED PROTOCOL BASED ON CURRENT MEDICAL
`PRACTICES BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.
`UMMARY HIGHLIGHTS OF COMPLICATIONS (consult curre nt 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 techniq ues 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, arte ry puncture and transection, injury to the brachia!
`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
`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 hypervitam inosis, electrolyte imbalances and hyperammonemia
`in children. Frequent evaluations are necessary especially d uring 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.
`nimal reproduction studies have not been conducted with Aminosyn It is not known whether
`minosyn can cause fetal harm when administered to a pregnant woman or can affect reproduction
`apacity. Aminosyn should be given to a pregnant woman only if clearly needed
`
`eriatric Use
`linical 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
`ifferences 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
`unction, and of concomitant d isease or other drug therapy. This d rug is known to be substantially
`xcreted by the kidney, and the risk of toxic reactions to t his drug may be g reater in patients with
`impaired renal function. Because elderly patients are more likely to have decreased renal function,
`are should be taken in dose selection, and it may be usefulto monitor re nal functions.
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`AMINOSYN - isoleucine X + v
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`lhttp://\w,w.drugsdb.eu/drug.php?d: Aminosyn&m=Hospira,%201nc.&id=2A72A8B8. A77C-49C6-3C8D-43B036720802.xml
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`LINICAL EVALUATION AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE
`TTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING
`DMINISTRATION. Do not withdraw venous blood for blood chemistries through the peripheral
`infusion site, as interference with estimations of nitrogen containing substances may occur. Blood
`t udies 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
`nd blood cultures are to be determined if indicated. Urinary osmolality and glucose should be
`etermined as necessary.
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`DVERSE REACTIONS
`eripheral Infusions
`4.25 or 5% solution of amino acids (without additives) is slightly hypertonic. A 3.5% concentration of
`mino acids (without additives) is slightly hypertonic. Local reactions consist ing of a warm sensation,
`rythema, phlebitis and thrombosis at the infusion site have occurred with pe ripheral intravenous
`infusion of amino acids particularly if other substances, such as antibiotics, are also administered
`hrough 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.
`eneralized flushing, fever and nausea also have been reported during peripheral infusions of amino
`cid solutions.
`
`VERDOSAGE
`In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate
`orrective measures. See WARNINGS and PRECAUTIONS.
`
`DOSAGE AND ADMINISTRATION
`he total daily dose of the solution depends on the daily protein requirement s 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 p revent hyperglycemia and
`lycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be
`dministered when hypertonic dextrose infusions are abruptly d iscontinued.
`Parenteral d rug products should be inspected visually for particulate matter and discoloration prior to
`dministration, 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 d iluted
`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.
`As with all intravenous fluid therapy, the primary aim is to provide sufficie nt water to compensate
`for insensible urinar and other naso astric suction fistula draina e d iarrhea fluid losses. Total
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`AMINOSYN • isoleucine X
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`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 Ve in Total Pare nteral 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.
`
`DULTS
`olutions containing 3.5 to 5% amino acids with 5 to 10% glucose may be coinfused with a fat
`mulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion
`oadministration should be considered when prolonged parenteral nutrition is required in order to
`prevent essential fatty acid deficiency (E.FAD.). Serum lipids should be monitored for evidence of
`EFAD in patients maintained on fat-free total parenteral nutrition.
`minosyn 5%, 7% (with or without electrolytes), 8.5% and 10% solutions should only be infused via a
`entral vein when admixed with sufficient dextrose to provide full caloric requirements in patients who
`require prolonged total parenteral nutrition. IV. lipid may be administered separately to provide part of
`he calories, if desired.
`otal 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
`at provides 9 kcal.
`he average depleted maior surgical patient with complications requires between 2500 and 4000 kcal
`nd 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 weighVday. Average
`aily adult fluid requirements are between 2500 and 3000 ml and may be much higher with losses
`rom 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.
`minosyn solutions without electrolytes are intended for patients requiring individualized electrolyte
`herapy. Sodium, chloride, potassium, phosphate, calcium and magnesium are major electrolytes
`hich should be added to Aminosyn as required.
`ERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. Electrolytes may be added to
`he nutrient solution as indicated by the patient's clinical condition and laboratory determinations of
`lasma values. Ma·or electro! tes are sodium chloride otassium hos hate ma nesium and
`
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`upplements should be given when long-term parenteral nutrition is undertaken.
`alcium and phosphorus are added to the solution as indicated. The usual dose of phosphate added
`o a liter of TPN solution (containing 25% dextrose) is 12 mM. This requirement is related to the
`arbohydrate calor ies delivered. Iron is added to the solution or given intramuscularly in depot form as
`indicated. Vitamin B12, vitamin Kand folic acid are given intramuscularly or added to the solution as
`esired.
`alcium 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
`extrose, and if the contents of both bottles are swirled before they are combined, then the likelihood
`f physical incompatibility is reduced.
`In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as
`he acetate or lactate salts to provide bicarbonate alternates.
`In adults, hyperton ic mixtures of amino acids and dextrose may be safely administered by continuous
`infusion through a cent ral venous catheter with the tip located in the vena cava. Typically, the 7% ,
`.5% or 10% solut ion is used in equal volume with 50% dextrose to provide an admixture containing
`3.5%, 4 .25% or 5% amino acids and 25% dextrose.
`he rate of intrave nous infusion initially should be 2 ml/min and may be increased gradually. If
`dministration sho uld fall behind schedule, no attempt to "catch up" to planned intake should be m ade.
`In addition to meet ing protein needs, the rate of administration is governed by the patient's glucose
`olerance estimated by glucose levels in blood and urine.
`minosyn 10% solution, when mixed with an appropriate volume of concentrated dextrose, offers a
`higher concentratio n of calories and nitrogen per unit volume. This solution is indicated for patients
`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 discomtinue
`dministration of n utritional solutions.
`EDIATRIC
`Pediatric requirements for parenteral nutrition are constrained t>y the greater relative fluid requirements
`f the infant and greater caloric requirements per kilogram. Amino acids are probably best
`dministered in a 2.5% concentration. For most pediatric patients on intravenous nutrition, 2.5 grams
`mino acids/kg/day with dextrose alone or with IV. lipid calories of 100 to 130 kcal/kg/day is
`recommended. In cases of malnutrition or stress, these requirements may be increased. It is
`cceptable 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
`he full strength pediatric solution (amino acids and dextrose) is given at a rate of 125 to 150
`ml/kg/day
`upplemental electrolytes and vitamin additives should be administered as deemed necessary by
`areful 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(cid:173)
`ree T PN. Bicarbon ate should not be administered during infusion of the nutritional solution unless
`eemed absolutely necessary
`o 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.
`basic solution for pediatric use should contain 25 grams of amino acids and 200 to 250 grams of
`lucose per 1000 m l , administered from bottles containing 250 or 500 ml. Such a solution given at
`he rate of 145 ml/kg/day provides 130 kcal/kg/day
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`AMINOSYN - isoleucine X + V
`[ 8 https:/ jWeb.archive.org{Web/20130831172706/http:jWwW.drugsdb.eu/drug.php?d =Aminosyn&n
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`HOW SUPPLIED
`
`List No.Concentration Container (ml )
`989 Aminosyn® 3. 5% 1000
`990 Aminosyn® 5% 1000
`500
`250
`992 Aminosyn® 7% 1000
`500
`5855 Aminosyn® 8. 5% 1000
`500
`991 Aminosyn® 10% 1000'
`500
`Provides sufficient volume to withdraw 1050 ml.
`Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from
`reezing. It is recommended that the product be stored at room temperature (25°C); however, brief
`xposure up to 40°C does not adversely affect the product. Avoid exposure to light.
`Rev: October, 2004
`
`Hos ira 2004EN-0642Printed in USA
`OSPIRA, INC., LAKE FOREST, IL 60045 USA
`
`HUMAN PRESCRIPTIOt~ DRUG
`INTRAVENOUS
`
`Item Code {Source)
`D EA Schedule
`
`NDC:0409-2989
`
`MINOSYN
`isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine. arginine. histidine.
`roline. serine, t rosine, and I cine in·ecuon. solution
`Product Information
`Product Type
`Route of Administration
`INGREDIENTS
`Name (Active Moiety)
`lsoleucine (lsoleucine)
`Leucine (leucine)
`!:Y.sine acetate C!:Y~
`Methionine (Methionine)
`Phenylalanine (Phenylalanine)
`Threonine ~ ine)
`Tryptophan (Tryplophan)
`Valine (Valine)
`Alanine (Alanine)
`Arginine (Arginine)
`Histidine (Histidine)
`Proline (Prolin~
`Serine (Serine)
`Tyrosine (Tyr~
`Glyci ne (Glycine)
`Sodium Hydrosuffite
`Acetic Acid
`Product Characteristics
`Color
`Shape
`Flavor
`Contains
`Packaging
`#Item Code
`
`,[ype
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Active
`Inactive
`Inactive
`
`Strength
`252 M ILLIGRAM In 100 MILLILITER
`1329 M ILLIGRAM In 100 MILLILITER
`252 M ILLIGRAM In 100 MILLILITER
`140 M ILLIGRAM In 100 MILLILITER
`154 M ILLIGRAM In 100 MILLILITER
`182 M ILLIGRAM In 100 MILLILITER
`56 M ILLIGRAM In 100 MILLILITER
`280 M ILLIGRAM In 100 MILLILITER
`448 M ILLIGRAM In 100 MILLILITER
`1343 M ILLIGRAM In 100 MILLILITER
`105 M ILLIGRAM In 100 MILLILITER
`!300 M ILLIGRAM In 100 MILLILITER
`147 M ILLIGRAM In 100 MILLILITER
`t31 M ILLIGRAM In 100 MILLILITER
`448 M ILLIGRAM In 100 MILLILITER
`76o M ILLIGRAM In 100 MILLILITER
`
`Score
`Size
`Imprint Code
`
`Package Description
`
`Multilevel Packaging
`
`
`
`Eton Ex. 1009
`9 of 11
`
`

`

`AMINOSYN - isoleucine X + v
`
`(cid:157)
`
`0
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`8 https://web.a rchive.org/web/20130831172706/http;fwww.drugsdb.eu/drug.php?d =Aminosyn&n
`
`*
`I[~ JUL
`(cid:141)
`,~cap-tures~~~~~~ - - - - -1 -11-1 -1-1 ~I
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`lt1ttp:ll\wtw.drugsdb.eu/drug.1php?d=Aminosyr1&m=Hospira,%201nc.&id =2A72A8B8-A77C-49C6-3C80-43B036720802.xml
`
`#Item Code
`1 0409-2990-05
`1
`2 0409-2990-03
`2
`3 0409-2990-02
`3
`
`31 Aug20t3-28Aug 2018
`Package Description
`6 B OTTLE In 1 CASE
`1000 ml ~IUTER) In 1 BOTTLE, GLASS
`~
`TTLE In 1 CASE
`500 ml (MILLILITER) In 1 BOTTLE, GLASS
`12 BOTTLE In 1 CASE
`250 ml
`ILLIUTER) In 1 BOTTLE GLASS
`
`Multilevel Packaging
`contains a BOTTLE, GLASS
`:~:i:aa~~~~t~~s';thin the CASE (0409-299.~0-~05~ - --,
`
`TtUs pac:kage is conta.ined within the CASE (0409-2990-03)
`contains a BOTTLE, GLASS
`n us pack e is contained within the CASE 0409-2990-02
`
`HUMAN PRESCRIPTION DRUG
`INTRAVENOU S
`
`Item Code ( Source}
`D EA Schedule
`
`NOC:0409-2992
`
`Strength
`Type
`510 MILLIGRAM In 100 MILLILITER
`Active
`Active ~ MILLIGRAM In 100 MILLILITER
`Active
`510 MILLIGRAM In 100 MILLILITER
`280 MILLIGRAM In 100 MILLILITER
`Active
`Active
`310 MILLIGRAM In 100 MILLILITER
`Active
`'370 MILLIGRAM In 100 MILLILITER
`Active
`120 MILLIGRAM In 100 MILLILITER
`Active
`560 MILLIGRAM In 100 MILLILITER
`900 MILLIGRAM In 100 MILLILITER
`Active
`Active ~
`90 MILLIGRAM In 100 MILLILITER
`Active
`210 MILLIGRAM In 100 MILLILITER
`Active
`610 MILLIGRAM In 100 MILLILITER
`300 MILLIGRAM In 100 MILLILITER
`Active
`Active
`44 MILLIGRAM In 100 MILLILllER
`900 MILLIGRAM In 100 MILLILITER
`Active
`Inactive~
`MILLIGRAM In 100 MILLILllER
`Inactive
`
`Score
`Size
`Imprint Code
`
`MINOSYN
`isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine,
`proline, serine, tyrosine, and glycine injection, solution
`Product lnfonnation
`Product Type
`Route of Administration
`INGREDIENTS
`Name (Active Moiety)
`lsoleucine (lsole~
`Leucine (Leucine)
`Lysine acetate (Lysine)
`Methioni ne (Melhionine)
`Phenylalanine ~
`nylalarune)
`Threonine ~
`ine)
`Tryptophan (Tryplophan)
`Valine (Valine)
`Alanine (Alanine)
`Arginine (Alg~
`Histidine (Histidine)
`Proline (Proline)
`Serine ~
`,Tyrosine (Ty~
`Glycine (Glycine)
`Potassi um Metabi sulfite
`Acetic Acid
`Product Characteristics
`Color
`Shape
`Flavor
`Contains
`Packaging
`#Item Code
`1 0409-2992-05
`1
`20409-2992-03
`2
`
`Package Description
`6 BOTTLE In 1 CASE
`1000 ml (MILLILITER) In 1 BOTTLE, GLASS
`12 BOTTLE In 1 CASE
`ILLILITER In 1 BOTTLE GLASS
`,500 ml
`
`Multilevel Packaging
`contains a BOTTLE, GLASS
`TtUs package is contained within the C~0409-2992-05)
`contains a BOTTLE, GLASS
`·s aci: