NDC 44206-251 Alburx

Albumin (human)

NDC Product Information

Alburx with NDC 44206-251 is a a plasma derivative product labeled by Csl Behring Ag. The generic name of Alburx is albumin (human). The product's dosage form is solution and is administered via intravenous form.

Labeler Name: Csl Behring Ag

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Plasma Derivative What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Alburx Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ALBUMIN HUMAN 12.5 g/50mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • SODIUM ACETYLTRYPTOPHANATE (UNII: 3EN9H0M2FX)
  • SODIUM CAPRYLATE (UNII: 9XTM81VK2B)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Human Serum Albumin - [EPC] (Established Pharmacologic Class)
  • Increased Intravascular Volume - [PE] (Physiologic Effect)
  • Increased Oncotic Pressure - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Serum Albumin - [Chemical/Ingredient]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Csl Behring Ag
Labeler Code: 44206
FDA Application Number: BLA102366 What is the FDA Application Number?
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.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 01-06-2009 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Alburx Product Label Images

Alburx Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

AlbuRx® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood.This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 0.14 M (3.2 mg/mL) sodium. The aluminum content is ≤ 200 mcg/L and the potassium content is ≤ 0.002 M. The solution is stabilized with 0.02 M sodium N-acetyltryptophanate and 0.02 M sodium caprylate. The solution contains no preservative.

Volume Deficit

Since the oncotic pressure of AlbuRx® 25, Albumin (Human) 25% solution is about four times higher than that of normal human serum, it will expand the plasma volume if interstitial water is available for an inflow through the capillary walls. However, many patients suffering from an acute volume deficit also have some degree of interstitial dehydration. In the absence of hyperhydration, the treatment of an acute volume deficit with AlbuRx® 25 should therefore include isotonic electrolyte solutions with an albumin:electrolyte ratio of 1:3 or 1:4. By contrast, chronic volume deficits have usually been at least partially compensated for by the renal retention of sodium and water with some degree of tissue edema, and in these circumstances a trial with AlbuRx® 25 only is indicated. In any case, an anemia of clinically relevant magnitude requires specific treatment, and the metabolic needs of the patient with respect to fluid and electrolytes must be cared for.

The appropriate AlbuRx® 25, Albumin (Human) 25% solution dose for the treatment of a volume deficit should be estimated from the recipient's hemodynamic response7, supplemented with the established safeguards against a circulatory overload. In the absence of active hemorrhage, the total dose should at any rate not exceed the normal circulating albumin mass, i.e. 2 g per kg body weight.

Oncotic Deficit

The common causes of hypoproteinemia are protein-calorie malnutrition, defective absorption in gastro-intestinal disorders, faulty albumin synthesis in chronic hepatic failure, increased protein catabolism postoperatively or with sepsis, and abnormal renal losses of albumin with chronic kidney disease. In all these settings, the circulating albumin mass is initially maintained by a gradual transfer of extravascular albumin to the circulation, and hypoproteinemia ensues only when this compensatory potential has been exhausted. This implies that manifest hypoproteinemia is usually accompanied by a hidden extravascular albumin deficit of equal magnitude as the measurable intravascular deficit, which must be allowed for if AlbuRx® 25, Albumin (Human) 25% solution is infused because of the capillary permeability of that protein.The primary sequel of the oncotic deficit resulting from hypoproteinemia is a loss of plasma and a gain of interstitial volume with increased lymphatic flow. As a secondary response, the kidney retains sodium and water which distribute themselves on both sides of the capillary walls and the plasma volume may be returned almost to normal when the interstitial hydrostatic pressure increases sufficiently to compensate for the decrease of the serum oncotic pressure. This chain of events is accelerated by the infusion of crystalloid fluids. The plasma volume is maintained at the price of interstitial edema.2There is some evidence that a serum oncotic pressure near 20 mmHg – equaling a total serum protein (TSP) concentration of 5.2 g/100 mL – represents a threshold, below which the risk of complications increases.17 The target organs of hypoproteinemia include the skin, the lungs, and the intestine.10 Cutaneous edema lowers the oxygen tension of wounds and may thus impair the healing process.5 An oncotic deficit favors the development of interstitial pulmonary edema4 and the intestinal accumulation of fluids, which may progress to a paralytic ileus.9Relief of the basic pathology is the definitive mode of therapy for the restoration of the plasma protein content, but this process takes time to become effective, and the rapid correction of a critical oncotic deficit by the administration of AlbuRx® 25, Albumin (Human) 25% solution – possibly in conjunction with a diuretic – may therefore be indicated, particularly in high-risk patients who have undergone abdominal, cardiovascular, thoracic, or urologic surgery or who have acute bacteremia. In notably catabolic patients, attempts to raise the TSP level above 6 g/100 mL usually prove futile, even with massive doses of Albumin (Human).17It is emphasized that whereas AlbuRx® 25, Albumin (Human) 25% solution may be necessary to prevent or treat the aforementioned acute complications of hypoproteinemia, it is not indicated for treatment of the chronic condition itself.

The appropriate AlbuRx® 25, Albumin (Human) 25% solution dose in grams of protein for the correction of an oncotic deficit can, as an average, be estimated from the difference between the desired and the actual TSP level x plasma volume (~40 mL/kg) × 2, the latter factor allowing for the hidden extravascular deficit. The individual effect is, however, variable and should be checked by measuring the post-infusion TSP level.10,17

Shock

Though electrolyte solutions such as Ringer's lactate and colloid-containing plasma substitutes may be used as an emergency treatment of shock, AlbuRx® 25, Albumin (Human) 25% solution used according to the aforementioned principles has a much longer intravascular half-life and may therefore be preferable. In addition, anemia of clinically relevant magnitude requires specific therapy with red cells.

Burns

Immediate therapy during the first 24 hours is directed at the administration of large volumes of crystalloid solutions and lesser amounts of AlbuRx® 25, Albumin (Human) 25% solution to maintain an adequate plasma volume and protein (colloid) content. For continuation of therapy beyond 24 hours, larger amounts of AlbuRx® 25 and lesser amounts of crystalloid are generally used.17 An optimum regimen for the use of Albumin (Human), electrolytes, and fluid in the early treatment of burns has, however, not yet been established.With restoration of normal capillary function, a close relationship exists once again between infused Albumin (Human) and resultant increase in plasma oncotic pressure. A goal should be sought of maintaining a plasma albumin concentration of about 2.5 ±0.5 g/100 mL or a plasma oncotic pressure of 20 mmHg (equivalent to a TSP concentration of 5.2 g/100 mL).17 In the presence of extensive granulating wounds, a daily loss of up to 30 g of albumin may continue into the late post-burn period.1 Protein-rich oral feedings, or adequate parenteral nutrition should be included in the overall regimen to the fullest possible extent, though such treatment does not permit the rapid correction of an oncotic deficit.

Adult Respiratory Distress Syndrome

Several factors are usually involved in the development of the state now commonly called the adult respiratory distress syndrome, one of these being a hypoproteinemic fluid overload. If present, this may be corrected by the use of AlbuRx® 25, Albumin (Human) 25% solution and a diuretic.14,17

Cardiopulmonary Bypass

An adequate blood volume during cardiopulmonary bypass can be maintained with crystalloids as the only pump priming fluid, but only at the price of interstitial edema. A commonly employed program is an AlbuRx® 25, Albumin (Human) 25% solution and crystalloid pump prime adjusted so as to achieve a hematocrit of 20% and a plasma albumin level of 2.5 g/100 mL in the patient, but the level to which either may be lowered safely has not yet been defined.17

Pre- And Postoperative Hypoproteinemia

Patients undergoing major surgery may lose more than half of their circulating albumin mass6,9,15, and complications attributable to an oncotic deficit may occur in such cases, as well as in septic and intensive care patients. Oncotic therapy with AlbuRx® 25, Albumin (Human) 25% solution may therefore be indicated in such patients, according to the principles outlined in Oncotic Deficit. Temporary redistribution of protein is usually not an indication for Albumin (Human).

Third Space Problems Of Infectious Origin

The sequestration of protein-rich fluid during acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis may be of sufficient magnitude to require the treatment of a volume or an oncotic deficit with AlbuRx® 25, Albumin (Human) 25% solution3, although this occurrence is relatively rare.

Acute Liver Failure

In acute liver failure, AlbuRx® 25, Albumin (Human) 25% solution may serve the triple purpose of stabilizing the circulation, correcting an oncotic deficit and binding excessive serum bilirubin. The therapeutic approach is guided by the individual circumstances.17

Acute Nephrosis

Patients with acute nephrosis may prove refractory to cyclophosphamide or steroid therapy and their edema may even be aggravated initially by steroids. In such cases, a response may be elicited by combining 100 mL of 20–25% Albumin (Human) solution with an appropriate diuretic. This combination should be repeated daily for about one week, after which the patient may react satisfactorily to drug therapy.17

Ascites

The use of AlbuRx® 25, Albumin (Human) 25% solution for blood volume support may be indicated if circulatory instability follows the withdrawal of ascitic fluid.

Red Cell Resuspension Media

As a rule, the use of Albumin (Human) for resuspending red cells can be dispensed with. However, in exceptional circumstances such as certain types of exchange transfusions and the use of very large volumes of erythrocyte concentrates and frozen or washed red cells, the addition of AlbuRx® 25, Albumin (Human) 25% solution to the resuspension medium may be indicated in order to provide sufficient volume and/or avoid excessive hypoproteinemia during the subsequent transfusion. If necessary, 20–25 g or more of Albumin (Human) per liter of red cell suspension should be added as a concentrated solution to the isotonic, electrolyte suspension of erythrocytes immediately before transfusion, the individual dosage depending on the TSP level of the recipient.

Renal Dialysis

Patients undergoing long-term hemodialysis may need AlbuRx® 25, Albumin (Human) 25% solution for the treatment of a volume or an oncotic deficit. As a rule, the initial dose should not exceed 100 mL of a 20–25% solution, and the patients should be carefully observed for signs of a circulatory overload, to which they are particularly sensitive.

Hemolytic Disease Of The Newborn

AlbuRx® 25, Albumin (Human) 25% solution may be indicated in order to bind and thus detoxify free serum bilirubin in severely hemolytic infants pending an exchange transfusion.

The appropriate AlbuRx® 25, Albumin (Human) 25% solution dose for the binding of free serum bilirubin in severely hemolytic infants is 1 g/kg body weight, to be given about one hour prior to the exchange transfusion, and caution is recommended in hypervolemic infants.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Circumstances In Which Alburx® 25, Albumin (Human) 25% Solution Use Is Not Justified

For the reasons set forth in sections CLINICAL PHARMACOLOGY. and General Principles, there is no valid reason for the use of AlbuRx® 25, Albumin (Human) 25% solution as an intravenous nutrient or for treating the stabilized hypoproteinemia accompanying chronic cirrhosis, chronic nephrosis, protein-losing enteropathy, malabsorption and pancreatic insufficiency.If, however, a patient in this category has to cope with a superimposed acute stress, e.g. anesthesia, surgery or major infections, the patient's hemodynamic state, oncotic deficit and fluid balance should be carefully assessed and the appropriate steps taken as indicated by the individual circumstances.

Contraindications

The only specific contraindication to the use of AlbuRx® 25, Albumin (Human) 25% solution is a history of an incompatibility reaction to Albumin (Human) in the individual recipient (see ADVERSE REACTIONS).

Warnings

AlbuRx® 25, Albumin (Human) 25% solution is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been extremely reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses through alcohol fractionation and through heat treatment of the product in the final container for 10 hours at 60°C. Despite these measures, such products can still potentially transmit disease. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for Albumin (Human). There is also the possibility that unknown infectious agents may be present in such products. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CSL Behring Pharmacovigilance Department at 1-866-915-6958. The physician should discuss the risks and benefits of this product with the patient.Turbid solutions must not be used. Do not begin administration more than 4 hours after introduction of the administration set. Partially used bottles must be discarded. There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of sterile water for injection as a diluent for AlbuRx® 25, Albumin (Human) 25% solution. Acceptable diluents include 0.9% sodium chloride or 5% dextrose in water.

Precautions

Adequate precautions should be taken against circulatory overload and may include pulmonary auscultation or X-ray as well as monitoring the central venous or pulmonary artery wedge pressure. Special caution is indicated in patients with stabilized chronic anemia, congestive heart failure and renal insufficiency.

Pregnancy Category C

Animal reproduction studies have not been conducted with AlbuRx® 25, Albumin (Human) 25% solution. It is also not known whether AlbuRx® 25 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlbuRx® 25 should be given to a pregnant woman only if clearly needed. There is, however, no evidence for any contraindication to the use of AlbuRx® 25 specifically associated with reproduction, pregnancy or the fetus.Use an intravenous infusion set suitable for the infusion of blood and blood products.

Adverse Reactions

Since AlbuRx® 25, Albumin (Human) 25% solution is sterile when coming from the manufacturer, bacterial contamination with the risk of post-infusion septicemia can only occur if the container has been damaged or following puncture of the rubber cap (see WARNINGS).Though very rare, non-septic incompatibility reactions including nausea, chills, fever, urticaria, headache and hypotension following the administration of albumin-containing preparations have been recorded.8,11,12,17 A favorable response was observed to the intravenous administration of 50 to 100 mg of prednisolone.12 Severe allergic reactions such as anaphylactic shock have been reported.

Dosage And Administration

AlbuRx® 25, Albumin (Human) 25% solution must be administered intravenously. The venipuncture site should not be infected or traumatized, and should be prepared with standard aseptic technique. The solution is compatible with whole blood or packed red cells as well as the usual electrolyte and carbohydrate solutions intended for intravenous use. By contrast, it should not be mixed with protein hydrolysates, amino acid mixtures, or solutions containing alcohol. It is ready for use as contained in the bottle and may be given without regard to the blood group of the recipient.The dosage of AlbuRx® 25, Albumin (Human) 25% solution is based on the principles outlined in the section on INDICATIONS AND USAGE but should always be adapted to the individual situation. The quantities required may be underestimated because of hidden extravascular deficits, and the effect of AlbuRx® 25 infusion on the serum protein level should therefore be checked by laboratory analysis.

How Supplied

AlbuRx® 25 is supplied as a 25% solution (250 g/L).Each product presentation includes a package insert and the following components:PresentationCarton NDC NumberComponents50 mL44206-251-05One vial containing 12.5 grams of albumin[NDC 44206-251-90]100 mL44206-251-10One vial containing 25 grams of albumin[NDC 44206-251-91]

Storage

AlbuRx® 25, Albumin (Human) 25% solution should be stored at a temperature not exceeding 30°C (86°F). It should not be used after the expiration date printed on the label.

References

  • Birke G, Liljedahl SO, Plantin LO, Reizenstein P. Acta Chir. Scand. 1968;134:27.Cervera AL, Moss G. J. Trauma. 1974;14:506.Clowes GH Jr, Vucinic M, Weidner MG. Ann. Surg. 1966;163:866.Gaar KA Jr, Taylor AE, Owens LJ, Guyton AC. Amer. J. Physiol. 1967;213:79.Heughan C, Niinikoski J, Hunt TK. Surg. Gynec. Obstet. 1972;135:257.Hoye RC, Paulson DF, Ketcham AS. Surg. Gynec. Obstet. 1970;131:943.Kinney JM, Egdahl RH, Zuidema GD. Manual of Preoperative and Postoperative Care, American College of Surgeons. Philadelphia: W. B. Saunders Co; 1971.Lowenstein E. In: Sgouris JT, René A, ed. Proceedings of the Workshop on Albumin, February 12–13. Bethesda, Maryland 20014: DHEW Publication NIH 76-925, NHLI; p. 302, 1975.Moss G. Surg. Forum. 1967;18:333.Pappova E, Bachmeier W, Crevoisier JL, Kollar J, Kollar M, Tobler P, Zahler HW, Zaugg D, Lundsgaard-Hansen P. Vox Sang. 1977;33:307.Ring J, Messmer K. Lancet. 1977;1:466.Ring J, Seifert J, Lob G, Coulin K, Brendel W. Klin. Wschr. 1974;52:595.Sgouris JT, René A, ed. Proceedings of the Workshop on Albumin, February 12–13. Bethesda, Maryland 20014: DHEW Publication NIH 76-925, NHLI; 1975.Skillman JJ, Parikh BM, Tanenbaum BJ. Amer. J. Surg. 1970;119:440.Skillman JJ, Tanenbaum BJ. Current Topics in Surgical Research. New York: Academic Press; 1970;2:523.Starling EH. J. Physiol. 1896;19:312-326.Tullis JL. JAMA. 1977;237:355,460.

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