| Product Description: | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55 |
|---|---|
| Status: | Ongoing |
| City: | Irvine |
| State: | CA |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | Nationwide, Puerto Rico and Spain |
| Classification: | Class I |
| Product Quantity: | 4614 units |
| Reason For Recall: | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units. |
| Recall Initiation Date: | 20131121 |
| Report Date: | 20140507 |
Freamine Hbc
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Questions & Answers
Side Effects & Adverse Reactions
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. Tissue 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 that have not been specifically formulated to treat patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Parenteral nutrition with 6.9% FreAmine HBC® (Amino Acid Injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See DOSAGE AND ADMINISTRATION.
Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, or those requiring long-term parenteral nutrition.
For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions with minimal caloric supplementation 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).
History
There is currently no drug history available for this drug.
Other Information
6.9% FreAmine HBC® (Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 750 mL partial fill unit provides a total of 7.3 g of nitrogen in 50 g of amino acids equal to 46 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 ............................................................ 0.76 g
Leucine USP ............................................................... 1.37 g
Lysine ......................................................................... 0.41 g
(added as Lysine Acetate USP .................................. 0.58 g)
Methionine USP .......................................................... 0.25 g
Phenylalanine USP ....................................................... 0.32 g
Threonine USP ............................................................ 0.20 g
Tryptophan USP ......................................................... 0.09 g
Valine USP ................................................................. 0.88 g
Nonessential Amino Acids
Alanine USP ............................................................... 0.40 g
Arginine USP .............................................................. 0.58 g
Histidine USP ............................................................. 0.16 g
Proline USP ............................................................... 0.63 g
Serine USP ................................................................. 0.33 g
Glycine USP ............................................................... 0.33 g
Cysteine .................................................................... <0.014 g
(as Cysteine HCl•H2O USP ................................... <0.020 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 – 7.0)
Calculated Osmolarity: 620 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3 Acetate Approx. 59.3 (provided as acetic acid and lysine acetate)
Sources
Freamine Hbc Manufacturers
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B. Braun Medical Inc.
![Freamine Hbc (Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Cysteine, And Sodium Bisulfite) Injection, Solution [B. Braun Medical Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Freamine Hbc | B. Braun Medical Inc.
The total daily dose of 6.9% FreAmine HBC® (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, 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 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 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.
The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is also required for optimum utilization of amino acids. Approximately 60 – 180 mEq of potassium, 10 – 30 mEq of magnesium, and 20 – 80 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 6.9% FreAmine HBC® 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.
Central Venous NutritionFor severely catabolic, depleted patients or those requiring long-term total parenteral nutrition, central venous nutrition should be considered. Total parenteral nutrition may be started with infusates containing lower concentrations of dextrose; dextrose content may be gradually increased to estimated caloric needs as the patient's glucose tolerance increases.
In adults, strongly hypertonic mixtures of amino acids and dextrose may be safely administered only by continuous infusion through a central venous catheter with the tip located in the vena cava. A mixture of 750 mL 6.9% FreAmine HBC® (Amino Acid Injection) solution, and 250 mL 70% Dextrose, supplemented with electrolytes, and vitamins may be administered over an 8-hour period. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the administration rate is also governed, especially during the first few days of therapy by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determination of urine and blood sugar levels. 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.
Peripheral Parenteral NutritionFor moderately catabolic, depleted patients requiring parenteral nutrition in whom the central venous route is not indicated, diluted 6.9% FreAmine HBC® with minimal caloric supplementation 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).
Fat provides approximately 9 kcal per gram and parenteral fat emulsion may be administered along with amino acid-dextrose solutions through a Y-type administration set to supplement caloric intake. Fat, however, should not provide more than 60% of the total caloric intake.
Pediatric UseUse of 6.9% FreAmine HBC® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L). See WARNINGS and PRECAUTIONS, Pediatric Use.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
6.9% FreAmine HBC® may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.
Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
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