AMINOSYN RF INJECTION SOLUTION

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Active ingredient:
ISOLEUCINE; LEUCINE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; LYSINE (LYSINE ACETATE); HISTIDINE; ARGININE
Available from:
HOSPIRA HEALTHCARE ULC
ATC code:
B05BA01
INN (International Name):
AMINO ACIDS
Dosage:
462MG; 726MG; 726MG; 726MG; 330MG; 165MG; 528MG; 535MG; 429MG; 600MG
Pharmaceutical form:
SOLUTION
Composition:
ISOLEUCINE 462MG; LEUCINE 726MG; METHIONINE 726MG; PHENYLALANINE 726MG; THREONINE 330MG; TRYPTOPHAN 165MG; VALINE 528MG; LYSINE (LYSINE ACETATE) 535MG; HISTIDINE 429MG; ARGININE 600MG
Administration route:
INTRAVENOUS
Units in package:
300ML
Prescription type:
Ethical
Therapeutic area:
CALORIC AGENTS
Product summary:
Active ingredient group (AIG) number: 1016903001; AHFS: 40:20.00
Authorization status:
APPROVED
Authorization number:
00640131
Authorization date:
2006-01-26

PRESCRIBING INFORMATION

AMINOSYN7 5%

AMINOSYN7 7%

AMINOSYN7 8.5%

AMINOSYN7 10%

AMINOSYN

TM/MD

RF INJECTION 5.2%

(amino acids for injection 5%, 7%, 8.5%, 10%, and 5.2% renal formula)

Sulfite-Free

Nutritive Supplement for Intravenous Infusion

Hospira Healthcare Corporation

Date of Revision: April 11, 2012

1111 Dr. Frederik-Philips, 6

floor

St-Laurent,Quebec

H4M 2X6

Control Nos. 150040 and 150041

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

Page 2 of 14

NAMES OF DRUGS:

AMINOSYN

AMINOSYN

AMINOSYN

8.5%

AMINOSYN

AMINOSYN

TM/MD

RF INJECTION 5.2%

(amino acids for injection 5%, 7%, 8.5%, 10%, and 5.2% renal formula)

Sulfite-Free

THERAPEUTIC OR PHARMACOLOGICAL CLASSIFICATION

Nutritive Supplement for Intravenous Infusion

ACTION

Protein Sparing (Peripheral Use)

It has been shown that it may be preferable for short periods of time, 3 to 5 days, to mobilize fat (as

in total starvation) for meeting energy requirements to spare protein.

Under conditions of total fasting, lipid mobilization provides energy substrate in the form of free fatty

acids and ketone bodies. Lipolysis occurs because insulin levels are low. If high concentrations of

carbohydrates are administered, insulin levels will rise and inhibit lipid mobilization. With brief

periods of fasting (less than 24 hours), energy requirements are usually met by glycogenolysis of the

glycogen stored in the liver. However, after glycogen is depleted, lipolysis of body fat becomes the

fat source of energy.

Thus, when amino acids (without dextrose) are infused into a peripheral vein, lipolysis and

ketogenesis occur freely and caloric requirements are met without proteolysis. This spares protein

and the body's muscle mass, while providing a substrate for essential protein synthesis.

Amino acid peripheral intravenous infusions result in: (1) availability of free fatty acids and ketone

bodies as sources of energy, and (2) the concomitant utilization of administered amino acids for

protein synthesis.

Adjunctive For Total Parenteral Nutrition (TPN)

Central vein infusion should be considered when amino acid solutions are to be admixed with

sufficient dextrose to meet fully caloric energy requirements for protein synthesis in patients

requiring prolonged total parenteral nutrition. Because of the highly irritant effect of hypertonic

dextrose solutions required to meet total energy needs over prolonged periods, peripheral vein

infusion of such solutions is not feasible. However, amino acids, infused together with total calories

provided by concentrated dextrose into a central vein, are utilized for repair and maintenance of body

proteins.

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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INDICATIONS AND CLINICAL USES

Peripheral Vein Administration

Aminosyn

5%, 7%, 8.5% and 10% (amino acids for injection 5%, 7%, 8.5% and 10%), Sulfite-Free are

indicated for peripheral vein infusion as a source of nitrogen in the intravenous treatment of acute surgical

patients.

AMINOSYN

-RF INJECTION 5.2% (amino acids for injection 5.2% - renal formula), Sulfite-Free is

indicated in patients with acute renal failure.

In those patients with adequate stores of body fat, for short periods of time oral nutrition cannot be tolerated

or is not desirable. In such instances, the patients' caloric needs are met from their own fat stores.

Central Vein Administration

Amino acids, when administered with concentrated dextrose solutions are also indicated for central vein

infusion as an adjunct in the prevention of nitrogen loss or in the treatment of negative nitrogen balance in

patients where: (1) the alimentary tract, by the oral, gastrostomy or jejunostomy route, cannot or should not be

used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are

substantially increased, as with extensive burns or in renal failure patients who cannot eat.

AMINOSYN

7%, 8.5% and 10%, when administered with Dextrose 50% Injection, are designed for central

vein infusion only. They are intended to meet the needs of hypermetabolic patients, such as those with burns

or trauma. They permit administration of great amounts of nitrogen and calories without excessive fluid. This

latter consideration is of importance in patients with cardiac or renal disease.

CONTRAINDICATIONS

AMINOSYN

and AMINOSYN

-RF are contraindicated in patients with previous hypersensitivity to these

product or any of their components.

These preparations should not be used in patients with hepatic coma or anuria or metabolic disorders

involving impaired nitrogen utilization. Patients with azotemia from any cause should not be infused with

amino acids without regard to total nitrogen intake.

WARNINGS

Intravenous infusion of amino acid solutions 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 BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE

FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.

THIS PRODUCT CONTAINS ALUMINUM THAT MAY BE TOXIC. ALUMINUM MAY REACH

TOXIC LEVELS WITH PROLONGED PARENTERAL ADMINISTRATION IF KIDNEY FUNCTION IS

IMPAIRED. PREMATURE NEONATES ARE PARTICULARLY AT RISK BECAUSE THEIR KIDNEYS

ARE IMMATURE, AND THEY REQUIRE LARGE AMOUNTS OF CALCIUM AND PHOSPHATE

SOLUTIONS, WHICH CONTAIN ALUMINUM.

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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RESEARCH INDICATES THAT PATIENTS WITH IMPAIRED KIDNEY FUNCTION, INCLUDING

PREMATURE NEONATES, WHO RECEIVE PARENTERAL LEVELS OF ALUMINUM AT GREATER

THAN 4 TO 5 μG/KG/DAY ACCUMULATE ALUMINUM AT LEVELS ASSOCIATED WITH

CENTRAL NERVOUS SYSTEM AND BONE TOXICITY. TISSUE LOADING MAY OCCUR AT EVEN

LOWER RATES OF ADMINISTRATION.

Central Vein Administration

: Central vein infusion (with added concentrated carbohydrate solutions) of

amino acid solutions requires knowledge of nutrition as well as clinical expertise in recognition and treatment

of the complications which can occur. Frequent clinical evaluation and laboratory determinations are

necessary for proper monitoring during administration. (see

PRECAUTIONS - Laboratory Tests

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.

Hyperammonemia is of special significance in infants, as it can result in mental retardation. It is essential that

blood ammonia 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.

Should symptoms of hyperammonemia develop, administration should be discontinued and patient's clinical

status re-evaluated.

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.

Use in Neonates

The safety and efficacy of AMINOSYN

7%, 8.5%, 10%, and -RF INJECTION 5.2% in neonates have not

been demonstrated.

Use in Children

The effect of infusion of amino acid solutions, without dextrose, upon carbohydrate metabolism of children is

not known at this time. Therefore, such usage of amino acids for injection 5%, 7%, 8.5%, 10%, and -RF

INJECTION 5.2% in children is not recommended.

Use in Pregnancy

Use in pregnancy has not yet been studied. Animal reproduction studies have not been conducted with

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

Page 5 of 14

AMINOSYN

and AMINOSYN

-RF. It is not known whether AMINOSYN

and AMINOSYN

-RF can

cause fetal harm when administered to a pregnant woman. AMINOSYN

and AMINOSYN

-RF should be

given to a pregnant woman only if clearly needed.

PRECAUTIONS

General

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.

Patients with Special Diseases and Conditions

Special care must be taken when giving hypertonic glucose to diabetic or pre-diabetic patients. Frequent

blood sugar determinations should govern insulin dosage.

Nitrogen intake should be carefully monitored in patients with impaired renal function.

Intravenously administered amino acids solutions should be used with caution in patients with history of renal

disease, pulmonary disease, cardiac insufficiency or with severe congestive heart failure, so as to avoid

excessive fluid replacement.

Drug Interactions

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential effects

of amino acids infused with dextrose as part of a parenteral feeding regimen.

Additives may be incompatible. When introducing additives, always consult with hospital pharmacist, use

aseptic technique, mix thoroughly, and do not store.

Laboratory Tests

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.

Because AMINOSYN

7%, 8.5% and 10% are strongly hypertonic, they should not be given by peripheral

vein unless they can be diluted to form a solution which is isotonic. All additives, such as trace elements, etc.,

should be taken into account for the dilution.

Serum electrolytes should be monitored and appropriate electrolytes added to the daily infusion regimen. Acid

base balance also should be monitored and disturbances in equilibrium corrected, as needed. The amino acid

solutions, as formulated, have no potential for increasing hydrogen ion concentrations.

Do not withdraw venous blood for blood chemistries through the peripheral infusion site; as interference with

estimations of nitrogen-containing substances may occur.

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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Frequent blood-sugar level measurements should be performed on diabetic patients receiving amino acid

solutions.

Long-Term Total Parenteral Nutrition

For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate

exogenous calories concurrently, if parenterally administered amino acids are to be retained by the body and

utilized for protein synthesis. Concentrated dextrose solutions are an effective source of such calories.

Strong 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 of amino acid solutions with concentrated dextrose and other nutrients via central venous

catheter may be associated with complications which can be prevented or minimized by careful attention 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. Although a detailed

discussion of the complications is beyond the scope of this monograph, the following summary lists those

based on current literature:

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 as well as recognition and treatment of

complications. For details of techniques 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

pneumothorax,

hemothorax,

hydrothorax,

artery

puncture

transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous

fistula, phlebitis, thrombosis and air and catheter embolus.

Septic

The constant risk of sepsis, especially fungal septicemia, is present during administration of all

parenteral nutritional solutions. Since contaminated solutions and infusion catheters are potential

sources of infection, it is imperative that the preparation of the solution and the placement and care of

catheters be accomplished under controlled aseptic conditions. Ideally, solutions should be prepared

in the hospital pharmacy under a laminar-flow hood. The key factor in their preparation is careful

aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition

of other nutrients.

Solutions should be used promptly after mixing. Any storage should be under refrigeration and

limited to a brief period of time less than 24 hours.

Administration time for a single container and set should never exceed 24 hours.

Do not administer any parenteral nutrition as a 3 in 1 mixture if the emulsion is cracked and/or oil is

visible at the surface of the parenteral nutrition.

Metabolic

The following complications have been reported with TPN administration: metabolic acidosis,

hypophosphatemia, alkalosis, hypocalcemia, osteoporosis, hyperglycemia and glycosuria, osmotic

diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo- and hyper-

vitaminosis, electrolyte imbalances and hyperammonemia in children. Frequent clinical evaluation

and laboratory determinations are necessary, especially during the first few days of therapy to prevent

or minimize these complications.

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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This product contains no more than 25 μg/L of aluminum.

ADVERSE REACTIONS

Hypersensitivity reactions ranging from rash and fever to hives, respiratory difficulties and anaphylaxis have

been noted. Local injection site reactions have also been noted.

Generalized flushing, fever and nausea have been reported during infusions of amino acid solutions.

WARNINGS

Special Precautions for Central Infusions

Peripheral Infusions

Local reactions consisting of a warm sensation, erythema, phlebitis, and thrombosis at the infusion site have

been reported 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 be

helpful in decreasing the incidence of local venous irritation. Electrolyte additives should be spread

throughout the day, and irritating additive medications may need to be injected at another venous site.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective

measures (see

WARNINGS

PRECAUTIONS

Potential overdosage with amino acid solutions will be indicated by nausea, chills, tachycardia, abdominal

pain and flushing. Normally, when the dosage prescribed is administered as directed, overdosage will not

occur. Should such symptoms persist, the administration of the solution should be terminated and the patient

observed for remission of these complaints. Plasma electrolyte determinations will indicate if a state of water

intoxication exists and what treatment should be instituted to correct this condition.

DOSAGE AND ADMINISTRATION

DO NOT USE FLEXIBLE CONTAINER IN SERIES CONNECTIONS.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration, whenever solution and container permit.

Additives may be incompatible. When introducing additives, always consult with hospital pharmacist, use

aseptic technique, mix thoroughly, and do not store.

The total daily dose of amino acid solution depends on daily protein requirements and the patient's metabolic

and clinical response.

As with all intravenous therapy, the primary aim is to provide sufficient water to compensate for insensible,

urinary and other (nasogastric suction, fistula drainage, diarrhea) fluid losses. Those requirements as well as

electrolyte and acid/base needs should be estimated and appropriately prescribed.

Given an amino acid solution of specified total concentration, the volume needed to meet amino acid require-

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

Page 8 of 14

ments 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 as a

noncarbohydrate- or carbohydrate-containing electrolyte solution.

Peripheral Vein Administration

Protein sparing:

AMINOSYN

5%, 7%, 8.5%, 10%, and AMINOSYN

-RF (without dextrose) can be administered by the

peripheral intravenous route.

AMINOSYN

7%, 8.5%, and 10% must be diluted prior to administration, so that a total dose of 1.5 g/kg/day

of amino acids is not exceeded. AMINOSYN

5%, 7%, 8.5%, 10%, and -RF INJECTION 5.2% should not

be infused via a central vein unless admixed with sufficient dextrose to provide full caloric energy

requirements in patients who require prolonged total parenteral nutrition.

Vitamins and additional electrolytes as needed to correct imbalances may be added to the amino acid solution.

Solutions of bicarbonate may be added to amino acid solutions, but the order of addition is important if

precipitation problems are to be avoided. If desired, one-half of an estimated daily amino acid requirement of

1.5 g/kg can be given on the first day. The degree of fat mobilization can be gauged by the presence and

amount of acetonuria. Amino acid dosage may be increased on the second day. Amino acid infusion into a

peripheral vein can be continued as long as oral nutrition is impaired. However, if a patient is unable to take

oral nourishment at the end of 5 days, institution of total parenteral nutrition with exogenous calories should

be considered.

Central Vein Administration

Adjunctive for total parenteral nutrition:

For central vein infusion with concentrated dextrose solution, the total daily dose of amino acid solution

depends on 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. For patients in a stable metabolic condition, the provision of amino

acids as a 3.5% concentration with 20 to 25% dextrose is usually considered adequate. AMINOSYN

may conveniently be diluted to double its volume with the dextrose solution. Vitamins, minerals and

electrolytes should be added as indicated.

AMINOSYN

8.5% and 10% may be diluted with an equal volume of Dextrose 50% Injection to give

solutions containing 4.25% and 5% amino acids, respectively, and 25% dextrose. These solutions, with a

higher concentration of nitrogen and calories per unit volume, are indicated for patients requiring larger

amounts of nitrogen than could otherwise be provided, or where the total fluid load must be kept to a

minimum.

If the rate of administration should fall behind schedule, no attempt to "catch up" to planned intake should be

made.

To prevent rebound hypoglycemia, do not discontinue administration of solution abruptly.

Potentially incompatible ions, such as calcium and phosphate, may be added to alternate infusate containers to

avoid precipitation. If one additive is added to the amino acid container and the other to the container of

concentrated dextrose, and if the contents of both containers are swirled before they are combined, then the

likelihood of physical incompatibility is reduced.

AMINOSYN

SOLUTIONS

WITHOUT

ELECTROLYTES

INTENDED

PATIENTS

REQUIRING INDIVIDUALIZED ELECTROLYTES THERAPY. SERUM ELECTROLYTES SHOULD

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

Page 9 of 14

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 TPN is undertaken.

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 desired.

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 superior vena cava.

AVAILABILITY

AMINOSYN

5% is supplied in 500 and 1000 mL flexible plastic containers; AMINOSYN

7% is supplied

in 500 mL flexible plastic containers; AMINOSYN

8.5% is supplied in 500 mL and 1000 mL flexible plastic

containers; AMINOSYN

10% is supplied in 500 mL and 1000 mL flexible plastic containers.

AMINOSYN

-RF INJECTION 5.2% is supplied in 500 mL flexible plastic containers.

A 500 or 1000 mL unit of AMINOSYN

5% provides a total equivalent of 50 g/L of protein and 7.86 g/L of

nitrogen. The pH (range) is 5.2 (4.5 to 6.0) adjusted with acetic acid. The osmolarity is 462 mOsmol/L.

Approx. mmol or mEq/L: acetate 86.

A 500 mL unit of AMINOSYN

7% provides a total equivalent of 70 g/L of protein and 11.0 g/L of

nitrogen. The pH (range) is 5.2 (4.5 to 6.0) adjusted with acetic acid. The osmolarity is 655 mOsmol/L.

Approx. mmol or mEq/L: acetate 105.

A 500 mL unit of AMINOSYN

8.5% provides a total equivalent of 85 g/L of protein and 13.4 g/L of

nitrogen. The pH (range) is 5.2 (4.5 to 6.0) adjusted with acetic acid. The osmolarity is 802 mOsmol/L.

Approx. mmol or mEq/L: chloride 35, acetate 90.

A 500 mL or 1000 mL unit of AMINOSYN

10% provides a total equivalent of 100 g/L of protein and 15.72

g/L of nitrogen. The pH (range) is 5.2 (4.5 to 6.0) adjusted with acetic acid. The osmolarity is 932

mOsmol/L. Approx. mmol or mEq/L: acetate 147.

A 500 mL unit of AMINOSYN

-RF INJECTION 5.2% provides a total equivalent of 52 g/L of protein and

8.7 g/L of nitrogen. The pH (range) is 5.2 (4.5 to 6.0) adjusted with acetic acid. The osmolarity is 427

mOsm/L. Approx. mmol or mEq/L : acetate 113.

Storage Conditions

Store between 20

and 25

C. Do not freeze. Protect from light. Avoid excessive heat.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can

permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution

significantly.

Solutions in contact with the plastic container may leach out certain chemical components from the plastic in

very small amounts; however, biological testing was supportive of the safety of the plastic container

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

Page 10 of 14

materials.

Exposure to temperature above 25

C/77

F during transport and storage will lead to minor losses in moisture

content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to

clinically significant changes within the expiration period.

Stability and Storage Recommendations following Constitution

Solutions should be used promptly after mixing. Any storage should be under refrigeration and limited to a

brief period of time less than 24 hours.

Administration time for a single container and set should never exceed 24 hours.

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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CHEMISTRY

AMINOSYN

(amino acids for injection) 5%, 7%, 8.5% and 10% are sterile, non-pyrogenic solutions for

intravenous infusion. Aminosyn is oxygen sensitive.

All the amino acids are present in the metabolizable L-form and the acetate salt of Lysine is used instead of

the hydrochloride salt in order to reduce the potential for precipitating or exacerbating metabolic acidosis

during infusion of the solution.

The following formula represents the optimal proportions of component crystalline amino acids in

AMINOSYN

5%, 7%, 8.5% and 10% expressed in grams (g) per 100 grams of amino acid content.

In the case of the amino acid L-Tyrosine, whose solubility is 0.44 mg/mL at room temperature (20

C), the

amount present in the optimal formulation does not vary with the concentration of other amino acids and thus

the actual amount of this amino acid in various strengths of AMINOSYN

will remain constant.

ESSENTIAL AMINO ACIDS

NON-ESSENTIAL AMINO ACIDS

L-Isoleucine

L-Alanine

12.9

L-Leucine

L-Arginine

L-Lysine (as acetate)

L-Histidine

L-Methionine

L-Proline

L-Phenylalanine

L-Serine

L-Threonine

L-Tyrosine

L-Tryptophan

Glycine

12.9

(Aminoacetic acid)

L-Valine

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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AMINOSYN

-RF INJECTION 5.2% provides the following quantities of amino acids expressed as grams

per 100 grams of amino acid content:

ESSENTIAL AMINO ACIDS

NON-ESSENTIAL AMINO ACIDS

L-Isoleucine

L-Arginine

11.5

L-Leucine

13.9

L-Histidine

L-Lysine (as acetate)

10.3

L-Methionine

13.9

L-Phenylalanine

13.9

L-Threonine

L-Tryptophan

L-Valine

10.1

AMINOSYN

solutions provide the following quantities of amino acids.

Aminosyn Formulations

Essential Amino Acids (mg/100 mL)

Aminosyn

5%

7%

8.5%

10%

RF 5.2%

Isoleucine

Leucine

Lysine (acetate)*

Methionine

Phenylalanine

Threonine

Tryptophan

Valine

* Amount cited is for Lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)

Aminosyn

5%

7%

8.5%

10%

RF 5.2%

Alanine

1100

1280

Arginine

Histidine

Proline

Serine

Tyrosine

Glycine

1100

1280

PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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REFERENCES

Blackburn, G.L., et al.: Peripheral intravenous feeding with isotonic amino acid solutions. Am. J.

Surgery 1973, 125: 447.

Blackburn, G.L., et al.: Protein sparing therapy during periods of starvation with sepsis or trauma.

Ann. Surg. 1973, 177:588.

Flatt, J.P., Blackburn, G.L.: The metabolic fuel regulatory system: implications for protein-sparing

therapies during caloric deprivation and disease. Am. J. Clin. Nutr. 1975, 27:175.

Anderson D.G., et al.: Design and evaluation by nitrogen balance and blood aminograms of an amino

acid mixture for total parenteral nutrition of adults with gastrointestinal disease. J. Clin. Inv. 1974,

53:904.

Dudrick, S.J., et al.: Long-term total parenteral nutrition with growth, development and positive

nitrogen balance. Surgery 1968, 64:134-142.

Dudrick, S.J., et al.: Can intravenous feeding as the sole means of nutrition support growth in the

child and restore weight loss in an adult? Ann. of Surgery 1969, 196:974-984.

Mervyn, D., et al.: A system of intravenous hyperalimentation. International Surg. 1973, 58:670-675.

Dudrick, S.J., et al.: Intravenous Hyperalimentation. Med. Clin. N. Am. 1970, 54 (3):577-589.

Curry, C.R., Quie, P.G.: Fungal septicemia in patients receiving parenteral hyperalimentation. New

Engl. J. Med. 1971, 285:1221-1225.

Rose, W.C., et al.: J. Biol. Chem. 1954, 210:331.

Munro, H.N.: (in) Symp. Total Parenteral Nutrition (Nashville, TN, USA), Chicago, IL, USA: Amer.

Med. Assoc. 1972, p. 7.

Blackburn, C.L., et al.: Amer. J. Surg. 1973, 135-447.

Howard, et al.: A Comparison of administering protein alone and protein plus glucose on nitrogen

balance. Am. J. Clin. Nutr. 1978, 31:226.

Elwyn, et al.: Protein and energy sparing of glucose added in hypocaloric amounts to peripheral

infusion of amino acids. Metabolism 1978, 27:325.

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PRESCRIBING INFORMATION; Aminosyn® 5%, 7%, 8.5%, 10% and RF Injection 5.2%

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