Freamine Iii
Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, Phosphoric Acid, And Sodium Bisulfite
B. Braun Medical Inc.
Human Prescription Drug
NDC 0264-9010Freamine Iii also known as Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, Phosphoric Acid, And Sodium Bisulfite is a human prescription drug labeled by 'B. Braun Medical Inc.'. National Drug Code (NDC) number for Freamine Iii is 0264-9010. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Freamine Iii drug includes Alanine - .71 g/100mL Arginine - .95 g/100mL Cysteine Hydrochloride - .016 g/100mL Glycine - 1.4 g/100mL Histidine - .28 g/100mL Isoleucine - .69 g/100mL Leucine - .91 g/100mL Lysine Acetate - .73 g/100mL Methionine - .53 g/100mL Phenylalanine - .56 g/100mL and more. The currest status of Freamine Iii drug is Active.
Drug Information:
| Drug NDC: | 0264-9010 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Freamine Iii |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, Phosphoric Acid, And Sodium Bisulfite |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | B. Braun Medical Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Injection, Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | ALANINE - .71 g/100mL
ARGININE - .95 g/100mL
CYSTEINE HYDROCHLORIDE - .016 g/100mL
GLYCINE - 1.4 g/100mL
HISTIDINE - .28 g/100mL
ISOLEUCINE - .69 g/100mL
LEUCINE - .91 g/100mL
LYSINE ACETATE - .73 g/100mL
METHIONINE - .53 g/100mL
PHENYLALANINE - .56 g/100mL
Load more...PHOSPHORIC ACID - .12 g/100mL
PROLINE - 1.12 g/100mL
SERINE - .59 g/100mL
THREONINE - .4 g/100mL
TRYPTOPHAN - .15 g/100mL
VALINE - .66 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRAVENOUS
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | NDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 24 Sep, 1971 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | NDA016822 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | B. Braun Medical Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1014427
1014431
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175780
M0000922
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | OF5P57N2ZX
94ZLA3W45F
ZT934N0X4W
TE7660XO1C
4QD397987E
04Y7590D77
GMW67QNF9C
TTL6G7LIWZ
AE28F7PNPL
47E5O17Y3R
Load more...E4GA8884NN
9DLQ4CIU6V
452VLY9402
2ZD004190S
8DUH1N11BX
HG18B9YRS7
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Amino Acid [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Amino Acids [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Amino Acid [EPC]
Amino Acids [CS]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0264-9010-55 | 6 CARTON in 1 CASE (0264-9010-55) / 1 CONTAINER in 1 CARTON / 1000 mL in 1 CONTAINER | 24 Sep, 1971 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Freamine iii isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, glycine, cysteine, phosphoric acid, and sodium bisulfite isoleucine isoleucine leucine leucine lysine acetate lysine methionine methionine phenylalanine phenylalanine threonine threonine tryptophan tryptophan valine valine alanine alanine arginine arginine histidine histidine proline proline serine serine glycine glycine cysteine hydrochloride cysteine phosphoric acid phosphoric acid water sodium bisulfite freamine iii isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, glycine, cysteine, phosphoric acid, and sodium bisulfite isoleucine isoleucine leucine leucine lysine acetate lysine methionine methionine phenylalanine phenylalanine threonine threonine tryptophan tryptophan valine valine alanine alanine arginine arginine histidine histidine proline proline serine serine glycine glycine cysteine hydrochloride cysteine phosphoric acid phosphoric acid water sodium bisulfite
Drug Interactions:
Drug interactions some additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic techniques. mix thoroughly. do not store.
Indications and Usage:
Indications and usage parenteral nutrition with 10% freamine® iii (amino acid injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults and pediatric patients where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. dosage, route of administration, and concomitant infusion of nonprotein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. see warnings , precautions, pediatric use , and dosage and administration . central venous nutrition central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in
Read more...hypercatabolic or severely depleted patients, or those requiring long-term parenteral nutrition. peripheral parenteral nutrition for moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion. in pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mosmol/l). protein sparing in well-nourished, mildly catabolic patients such as routine postsurgical patients who require only short-term parenteral nutrition, protein sparing can be achieved by peripheral infusion of amino acid solutions with or without dextrose.
Warnings:
Warnings this product contains sodium bisulfite, a sulfite 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. warning: 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. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tiss
Read more...ue loading may occur at even lower rates of administration. safe and effective use of central venous nutrition requires a 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 of central venous nutrition. laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. other laboratory tests may be suggested by the patient's condition. the intravenous administration of these solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. the risk of dilutional states is inversely proportional to the solute concentration of the solution infused. the risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the concentration of the solution. administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake. administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. hyperammonemia is of special significance in infants as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. this reaction appears to be dose related and is more likely to develop during prolonged therapy. it is essential that blood ammonia be measured frequently in infants. the mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function. conservative doses of amino acids should be given, dictated by the nutritional status of the patient. should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reevaluated.
General Precautions:
General clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. significant deviations from normal concentrations may require the use of additional electrolyte supplements. strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava. care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency. in patients with myocardial infarct, infusion of amino acids should always be accompanied by dextrose, since in anoxia, free fatty acids cannot be utilized by the myocardium, and energy must be produced anaerobically from glycogen or glucose. special care must be taken when giving hypertonic dextrose to a diabetic or prediabetic patient. to prevent severe hype
Read more...rglycemia in such patients, insulin may be required. administration of glucose at a rate exceeding the patient's utilization may lead to hyperglycemia, coma, and death. administration of amino acids without carbohydrates may result in the accumulation of ketone bodies in the blood. correction of this ketonemia may be achieved by the administration of carbohydrate. after appropriate dilution, if 10% freamine® iii (amino acid injection) is to be administered by peripheral vein, care should be taken to assure proper placement of the infusion device within the lumen of the vein. the venipuncture site should be inspected frequently for signs of infiltration. if venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiate appropriate treatment. extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation. metabolic acidosis can be prevented or readily controlled by adding a portion of the cations in the electrolyte mixture as acetate salts and in the case of hyperchloremic acidosis, by keeping the total chloride content of the infusate to a minimum. 10% freamine® iii contains less than 3 meq chloride per liter. 10% freamine® iii contains phosphorus. patients, especially those with hypophosphatemia, may require additional phosphate. to prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. to assure adequate intake, serum levels should be monitored frequently. to minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. use only if solution is clear and vacuum is present. drug product contains no more than 25 mcg/l of aluminum.
Dosage and Administration:
Dosage and administration the total daily dose of 10% freamine® iii (amino acid injection) depends on daily protein requirements and on 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. while recommended dietary allowances of protein are approximately 0.8 g/kg of body weight for a healthy adult and 1.4 to 2.2 g/kg for healthy growing infants and pediatric patients. it must be recognized that protein as well as caloric requirements in traumatized or malnourished patients may be substantially increased. daily amino acid doses of approximately 1.5 g/kg of body weight for adults and 2 to 3 g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. higher doses may be required in severely catabolic states. such higher doses, especially
Read more...in infants, must be accompanied by frequent laboratory evaluation. fat emulsion may be supplied to help meet energy requirements. fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (e.f.a.d.). serum lipids should be monitored for evidence of e.f.a.d. in patients maintained on fat free tpn. for protein sparing in well-nourished patients not receiving significant additional calories, amino acid dosages of 1.0 to 1.7 g/kg/day significantly reduce nitrogen losses and spare body protein. if rises in bun exceed 20 mg% in 48 hours, amino acid infusion should be discontinued or rate of administration reduced. the provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is also required for optimum utilization of amino acids. approximately 60â180 meq of potassium, 10â30 meq of magnesium, and 20â80 meq of phosphate per day appear necessary to achieve optimum metabolic response. in addition, sufficient quantities of the major extracellular electrolytes (sodium, calcium, and chloride) must be given. in patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate precursor. the electrolyte content of 10% freamine® iii (amino acid injection) must be considered when calculating daily electrolyte intake. serum electrolytes, including magnesium and phosphorus, should be monitored frequently. if a patient's nutritional intake is primarily parenteral, vitamins, especially the water soluble vitamins, and trace elements should also be provided.
Contraindications:
Contraindications 10% freamine® iii is contraindicated in patients with anuria, hepatic coma, inborn errors of amino acid metabolism, or hypersensitivity to one or more amino acids present in the solution.
Adverse Reactions:
Adverse reactions see " warnings " and " special precautions for central venous nutrition ." reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. local reactions of the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site. generalized flushing, fever and nausea have been reported during peripheral administration of amino acids. symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential. if electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order
Read more...to avoid possible venous irritation. irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate. phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Drug Interactions:
Drug interactions some additives may be incompatible. consult with pharmacist. when introducing additives, use aseptic techniques. mix thoroughly. do not store.
Use in Pregnancy:
Pregnancy teratogenic effects animal reproduction studies have not been conducted with 10% freamine® iii (amino acid injection). it is also not known whether 10% freamine® iii can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% freamine® iii should be given to a pregnant woman only if clearly needed.
Pediatric Use:
Pediatric use safety and effectiveness of amino acid injections in pediatric patients have not been established by adequate and well-controlled studies. however, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is well established in the medical literature. see indications and usage , warnings , and dosage and administration .
Geriatric Use:
Geriatric use clinical studies of 10% freamine® iii (amino acid injection) did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or 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 useful to monitor renal function. see warnings .
Overdosage:
Overdosage in the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment.
Description:
Description 10% freamine® iii (amino acid injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. each 1000 ml provides a total of 15.3 g of nitrogen in 97 g of amino acids equal to 95.6 grams of protein equivalent. all amino acids designated usp are the "l"-isomer, with the exception of glycine usp, which does not have an isomer. each 100 ml contains: essential amino acids isoleucine usp ............................................................ 0.69 g leucine usp ............................................................... 0.91 g lysine usp ................................................................. 0.73 g (added as lysine acetate usp .................................. 1.02 g) methionine usp .......................................................... 0.53 g phenylalanine usp ....................................................... 0.56 g threonine usp ............................................................ 0.40 g tryptophan usp ......................................................... 0.15 g valine usp ................................................................. 0.66 g nonessential amino acids alanine usp ............................................................... 0.71 g arginine usp .............................................................. 0.95 g histidine usp ............................................................. 0.28 g proline usp ............................................................... 1.12 g serine usp ................................................................. 0.59 g glycine usp ............................................................... 1.40 g cysteine .................................................................... <0.016 g (as cysteine hclâ¢h 2 o usp ................................... <0.024 g) phosphoric acid nf................................................... 0.12 g sodium bisulfite (as an antioxidant) ............................. <0.10 g water for injection usp .............................................. qs ph adjusted with glacial acetic acid usp ph: 6.5 (6.0 â 7.0) calculated osmolarity: 950 mosmol/liter concentration of electrolytes (meq/liter): sodium 10 phosphate (hpo ) 20 (10 mmole p/liter); acetate approx. 89 (provided as acetic acid and lysine acetate); chloride <3. figure
Clinical Pharmacology:
Clinical pharmacology 10% freamine® iii provides a physiological ratio of biologically utilizable amino acids in concentrated form for protein synthesis. used with concentrated calorie sources such as hypertonic dextrose or fat emulsion, and with electrolytes, vitamins and minerals, it provides total parenteral nutrition. administered peripherally as an isotonic solution (3%) without nonprotein calories or with minimal caloric supplementation such as 5% dextrose, it provides nutritional support and spares body protein. phosphate is a major intracellular anion which participates in providing energy for metabolism of substrates and contributes to significant metabolic and enzymatic reactions in all organs and tissues. it exerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium and has a primary role in the renal excretion of hydrogen ions. it is thought that the acetate from lysine acetate and acetic acid, under the condition of parenteral nutrition,
Read more... does not impact net acid-base balance when renal and respiratory functions are normal. clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available. the amounts of sodium and chloride present are not of clinical significance.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis, impairment of fertility no in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with 10% freamine® iii (amino acid injection).
How Supplied:
How supplied 10% freamine® iii is supplied sterile and nonpyrogenic in glass intravenous infusion bottles with solid stoppers. the 1000 ml containers are packed 6 per case. ndc ref size 10% freamine® iii (amino acid injection) 0264-9010-55 s9010-ss 1000 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. protect from light until use.
Package Label Principal Display Panel:
Principal display panel - 1000 ml container label 10% freamine ® iii (amino acid injection) ref s9010-ss ndc 0264-9010-55 1000 ml protect from light until use. each 100 ml contains: essential amino acids â isoleucine usp 0.69 g leucine usp 0.91 g; lysine 0.73 g (added as lysine acetate usp 1.02 g) methionine usp 0.53 g; phenylalanine usp 0.56 g threonine usp 0.40 g; tryptophan usp 0.15 g valine usp 0.66 g nonessential amino acids â alanine usp 0.71 g arginine usp 0.95 g; histidine usp 0.28 g proline usp 1.12 g; serine usp 0.59 g glycine usp 1.40 g; cysteine <0.016 g (as cysteine hclâ¢h 2 o usp <0.024 g) b. braun medical inc. bethlehem, pa 18018-3524 usa 1-800-227-2862 phosphoric acid nf 0.12 g sodium bisulfite (antioxidant) <0.10 g water for injection usp qs ph adjusted with glacial acetic acid usp ph: 6.5 (6.0-7.0) calculated osmolarity: 950 mosmol/liter electrolytes (meq/liter): sodium 10 phosphate (hpo ) 20 (10 mmole p/liter) acetate 89 (see package insert) chloride <3 sterile, nonpyrogenic. single dose container. for intravenous use only. use only if solution is clear and vacuum is present. recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only freamine is a registered trademark of b. braun medical inc. y37-002-546 ld-357-2 symbol s9010-ss container label
Principal display panel - 1000 ml container carton 10% freamine ® iii (amino acid injection) ref s9010-ss ndc 0264-9010-55 1000 ml protect from light until use. each 100 ml contains: essential amino acids â isoleucine usp 0.69 g; leucine usp 0.91 g lysine 0.73 g (added as lysine acetate usp 1.02 g) methionine usp 0.53 g; phenylalanine usp 0.56 g threonine usp 0.40 g; tryptophan usp 0.15 g valine usp 0.66 g nonessential amino acids â alanine usp 0.71 g; arginine usp 0.95 g histidine usp 0.28 g; proline usp 1.12 g serine usp 0.59 g; glycine usp 1.40 g cysteine <0.016 g (as cysteine hclâ¢h 2 o usp <0.024 g) phosphoric acid nf 0.12 g sodium bisulfite (antioxidant) <0.10 g water for injection usp qs ph adjusted with glacial acetic acid usp ph: 6.5 (6.0-7.0) calculated osmolarity: 950 mosmol/liter electrolytes (meq/liter): sodium 10 phosphate (hpo ) 20 (10 mmole p/liter) acetate 89 (see package insert) chloride <3 see adjacent panel for further product information. b. braun medical inc. bethlehem, pa 18018-3524 usa 1-800-227-2862 sterile, nonpyrogenic. single dose container. for intravenous use only. use only if solution is clear and vacuum is present. recommended storage: room temperature (25°c). avoid excessive heat. protect from freezing. see package insert. rx only freamine is a registered trademark of b. braun medical inc. x12-002-487 ld-612-1 symbol s9010-ss folding carton