AlbuRx (Page 2 of 2)

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with AlbuRx® 5, Albumin (Human) 5% solution. It is also not known whether AlbuRx® 5 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AlbuRx® 5 should be given to a pregnant woman only if clearly needed. There is, however, no evidence for any contraindication to the use of AlbuRx® 5 specifically associated with reproduction, pregnancy or the fetus.

Use an intravenous infusion set suitable for the infusion of blood and blood products.

7. ADVERSE REACTIONS

Since AlbuRx® 5, Albumin (Human) 5% 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 occasionally been observed.6,8,9,16 A favorable response to the intravenous administration of 50 to 100 mg of prednisolone was recorded.9

8. DOSAGE AND ADMINISTRATION

AlbuRx® 5, Albumin (Human) 5% 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.

Upon administration of AlbuRx® 5, Albumin (Human) 5% solution, there is a rapid increase of the plasma volume about equal to the volume infused. The initial dose for adults is 250 or 500 mL. The rate of infusion and the total volume administered are determined by the condition and response of the patient. A rate of 1–2 mL per minute is usually suitable in the absence of overt shock, whereas the capacity of the administration set is the only limit in the exsanguinated patient.

During resuscitation, constant monitoring of the patient provides the guidelines for treatment.

For children, a dose of 10 to 15 mL per pound body weight is usually adequate and close surveillance of the young patient is essential. Since patients – notably those with sepsis or severe multiple injuries – often need a circulating blood volume exceeding the prediction derived from their body weight, treatment should always be guided by the hemodynamic response and not by blood volume calculations or measurements.5

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

9. HOW SUPPLIED

AlbuRx® 5, Albumin (Human) 5% solution is supplied in 250 mL (NDC 44206-310-25) or 500 mL (NDC 44206-310-50) vials, with complete directions for use.

10. STORAGE

AlbuRx® 5, Albumin (Human) 5% 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

  1. Clowes GHA Jr, Vucinic M, Weidner MG. Ann. Surg. 1966;163:866.
  2. Gaar KA Jr, Taylor AE, Owens LJ, Guyton AC. Amer. J. Physiol. 1967;213:79.
  3. Heughan C, Niinikoski J, Hunt TK. Surg. Gynec. Obstet. 1972;135:257.
  4. Hoye RC, Paulson DF, Ketcham AS. Surg. Gynec. Obstet. 1970;131:943.
  5. Kinney JM, Egdahl RH, Zuidema GD. Manual of Preoperative and Postoperative Care, American College of Surgeons. Philadelphia: W. B. Saunders Co: 1971.
  6. 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.
  7. Moss G. Surg. Forum. 1967;18:333.
  8. Ring J, Messmer K. Lancet. 1977;1:466.
  9. Ring J, Seifert J, Lob G, Coulin K, Brendel W. Klin. Wschr. 1974;52:595.
  10. Sgouris JT, René A, ed. Proceedings of the Workshop on Albumin, February 12–13. Bethesda, Maryland 20014: DHEW Publication NIH 76-925, NHLI; 1975.
  11. Simmons RL, Heisterkamp CA, Collins JA, Bredenberg CE, Martin AM. J. Trauma. 1969;9:760.
  12. Skillman JJ, Parikh BM, Tanenbaum BJ. Amer. J. Surg. 1970;119:440.
  13. Skillman JJ, Restall DS, Salzman EW. Surgery. 1975;78:291.
  14. Skillman JJ, Tanenbaum BJ. Current Topics in Surgical Research. Vol. 2. New York: Academic Press; 1970:523.
  15. Starling EH. J. Physiol. 1896;19:312-326.
  16. Tullis JL. JAMA. 1977:237:355,460.

Manufactured by:
CSL Behring AG
Bern, Switzerland
US License No. 1766

Distributed by:
CSL Behring LLC
Kankakee, IL 60901 USA

Revised: June 2007

Package Label — Principal Display Panel — 250 mL

NDC 44206-310-25

5%

AlbuRx® 5
Albumin (Human) 5% Solution

250 mL

For intravenous administration

Rx only

CSL Behring

Front Package
(click image for full-size original)

Package Label — Principal Display Panel — 500 mL

NDC 44206-310-50

5%

AlbuRx® 5
Albumin (Human) 5% Solution

500 mL

For intravenous administration

Rx only

CSL Behring

Front Package
(click image for full-size original)
ALBURX
albumin human solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44206-310
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human (Albumin Human) Albumin Human 12.5 g in 250 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
POTASSIUM CHLORIDE
SODIUM ACETYLTRYPTOPHANATE
SODIUM CAPRYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44206-310-25 1 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
1 250 mL in 1 VIAL, GLASS This package is contained within the CARTON (44206-310-25)
2 NDC:44206-310-50 1 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
2 500 mL in 1 VIAL, GLASS This package is contained within the CARTON (44206-310-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102366 01/06/2009
Labeler — CSL Behring AG (481152762)
Establishment
Name Address ID/FEI Operations
CSL Behring LLC 931896963 MANUFACTURE

Revised: 01/2009 CSL Behring AG

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