Albuminar-20 (Page 2 of 2)

GENERAL

If dehydration is present additional fluids must accompany or follow the administration of albumin. Administration of large quantities of albumin should be supplemented with red blood cells or replaced by whole blood to combat the relative anemia which would follow such use. The quick response of blood pressure which may follow the rapid administration of concentrated albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at lower blood pressure. Albumin (Human) 20% should be administered with caution to patients with low cardiac reserve or with no albumin deficiency because a rapid increase in plasma volume may cause circulatory embarrassment (e.g. hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired — 200 mL of albumin solution may be mixed with 200 mL of 10% dextrose solution and administered at a rate of 10 grams of albumin (100 mL) per hour.

If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Infusion rates and the patient’s clinical state should be monitored closely during infusion.

INFORMATION FOR PATIENT

Some viruses, such as parvovirus B19 or hepatitis A are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect pregnant women, or immune-compromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (community acquired) sources.

PREGNANCY CATEGORY C

Animal reproduction studies have not been conducted with Albuminar® -20. It is also not known whether Albuminar® -20 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuminar® -20 should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE

No clinical studies using Albuminar® -20 have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albuminar® -20 in the same manner as adults.

Adverse Reactions to Albuminar-20

The incidence of untoward reactions to Albuminar® -20 is low. Reports have been received of anaphylaxis, which may be severe, and hypersensitivity reactions (including urticaria, skin rash, pruritus, edema, erythema, hypotension and bronchospasm). Nausea, vomiting, increased salivation, chills and febrile reactions have also been reported (see also PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Albuminar® -20 may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration. 250 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma.

When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough to prevent too rapid expansion of plasma volume.

In the treatment of shock, an initial dose of 100 mL of the 20% albumin solution is given as rapidly as tolerated. If response within 30 minutes is inadequate, an additional 100 mL of 20% albumin solution may be given. Therapy should be guided by the clinical response, blood pressure and an assessment of relative anemia. If more than 250 mL are given, or if hemorrhage has occurred, the administration of packed red blood cells may be desirable.

In severe burns, immediate therapy should include large volumes of crystalloid with lesser amounts of 20% albumin solution to maintain an adequate plasma volume and protein content. After the first 24 hours, the ratio of albumin to crystalloid may be increased to establish and maintain a plasma albumin level of about 2.5 g/100 mL or a total serum protein level of about 5.2 g/100 mL.

The infusion of Albumin (Human) as a nutrient in the treatment of chronic hypoproteinemia is not recommended. In acute hypoproteinemia 250-350 mL of 20% albumin may be required to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, the rate of administration should not be greater than 3 mL per minute to avoid circulatory embarrassment.

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

HOW SUPPLIED

Albuminar® -20 is supplied as a 20% solution in:

50 mL vials containing 10 grams of albumin (NDC 0053-7695-33)
100 mL vials containing 20 grams of albumin (NDC 0053-7695-34)

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

REFERENCES

  1. Data on file.

BIBLIOGRAPHY

Finlayson, J.S.: Albumin Products. Seminars in Thrombosis and Hemostasis 6:85-120, 1980.

Tullis, J.L.: Albumin. JAMA 237: 355-360 and 460-463, 1977.

Rudolf, A.M.: Pediatrics. 18th ED., p. 1839, Appleton and Lange, 1987.

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA

Revised May, 2008
12480-04

Package Label — Principal Display Panel — 50 mL Carton

NDC 0053-7695-33

20%

50 mL

Albuminar® -20
Albumin (Human)
USP 20%

For Intravenous Administration Only.

10 g in 50 mL solution osmotically equivalent to 200 mL of plasma.

Do not use if turbid.

Do not begin administration more than 4 hours after the container has been entered.

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

RX only

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

CSL Behring

Principal Display Panel -- 50 mL Carton
(click image for full-size original)

Package Label — Principal Display Panel — 100 mL Carton

NDC 0053-7695-34

20%

100 mL

Albuminar® -20
Albumin (Human)
USP 20%

For Intravenous Administration Only.

20 g in 100 mL solution osmotically equivalent to 400 mL of plasma.

Do not use if turbid

Do not begin administration more than 4 hours after the container has been entered.

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

RX only

Manufactured by:
CSL Behring LLC
Kankakee, IL 60901 USA
US License No. 1767

CSL Behring

Principal Display Panel -- 100 mL Carton
(click image for full-size original)
ALBUMINAR-20
albumin human solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0053-7695
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human (Albumin Human) Albumin Human 20 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
Sodium bicarbonate
Sodium hydroxide
Acetic Acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0053-7695-33 1 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
1 50 mL in 1 VIAL, GLASS This package is contained within the CARTON (0053-7695-33)
2 NDC:0053-7695-34 1 VIAL, GLASS (VIAL) in 1 CARTON contains a VIAL, GLASS
2 100 mL in 1 VIAL, GLASS This package is contained within the CARTON (0053-7695-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103955 01/06/2009
Labeler — CSL Behring LLC (931896963)
Establishment
Name Address ID/FEI Operations
CSL Behring LLC 931896963 MANUFACTURE

Revised: 01/2009 CSL Behring LLC

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.