Albumin
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ALBUMIN (HUMAN) 20% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]
When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [ 1 ]
For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, ALBUMIN (HUMAN) 20% infusions may be indicated. [ 3 ] When albumin deficit is the result of excessive protein loss, the effect of administration of ALBUMIN (HUMAN) 20% will be temporary unless the underlying disorder is reversed.
ALBUMIN (HUMAN) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [ 2 ]
ALBUMIN (HUMAN) 20% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]
ALBUMIN (HUMAN) 20% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [ 5 ]
ALBUMIN (HUMAN) 20% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [ 1 ]
ALBUMIN (HUMAN) 20% is indicated in the treatment of hyperbilirubinemia. It may be used prior to or during an exchange procedure in an attempt to bind free and to enhance its removal. [ 6 ]
History
There is currently no drug history available for this drug.
Other Information
ALBUMIN (HUMAN) 20% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 20% are provided by FDA approved blood establishments only.
The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 20% manufacturing process provides a significant viral reduction in in vitro studies (table 2). These reductions are achieved through a combination of process steps including Cohn fractionation and final container pasteurization.
No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma.[see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]
Table 2 In vitro reduction factor during ALBUMIN (HUMAN) 20% manufacturing
PRV:Pseudorabies Virus
SBV: Sindbis Virus
HIV-1:Human Immunodeficiency Virus - 1
Reo 3:Reovirus Type 3
PPV:Porcine Parvovirus
HAV:Hepatitis A Virus
ALBUMIN (HUMAN) 20% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green.
The composition of ALBUMIN (HUMAN) 20% is as follows:
| Component | Quantity/1000 ml | |
|---|---|---|
| Protein, of which greater than or equal to |
||
| 96% is human albumin |
200 g |
|
| Sodium |
130 – 160 mmol |
|
| Potassium |
less than or equal to 2 mmol |
|
| N-acetyl-DL-tryptophan |
0.064 - 0.096 mmol/g protein |
|
| Caprylic acid |
0.064 - 0.096 mmol/g protein |
|
| Water for Injection |
ad. 1000 ml |
ALBUMIN (HUMAN) 20% contains no preservatives and components used in its packaging are latex-free.
Sources
Albumin Manufacturers
-
Octapharma Usa Inc
![Albumin (Human) (Albumin Human) Solution [Octapharma Usa Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Albumin | Octapharma Usa Inc
2.1 DosageGeneral Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.
The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 20% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 20%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 20% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 20% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 20% may be given for every 1,000 mL of ascitic fluid removed.
Ovarian Hyperstimulation Syndrome
In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 20% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]
Adult Respiratory Distress Syndrome (ARDS)
In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]
Induction of Diuresis in Patients with Acute Nephrosis
In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.
Hemolytic Disease of the Newborn
In newborns, ALBUMIN (HUMAN) 20% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]
2.2 AdministrationIntravenous use only.
Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.
Do not dilute with sterile water for injection.
Do not use solutions of ALBUMIN (HUMAN) 20% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 20% is not required.
The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.
If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
-
Octapharma Usa Inc
Albumin | Octapharma Usa Inc
2.1 DosageGeneral Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 5% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g of ALBUMIN (HUMAN) 5% should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 5%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 5% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 5% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 5% may be given for every 1,000 mL of ascitic fluid removed.
2.2 AdministrationIntravenous use only.
Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.
Do not dilute with sterile water for injection.
Do not use solutions of ALBUMIN (HUMAN) 5% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 5% is not required.
The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.
If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
-
Octapharma Usa Inc
Albumin | Octapharma Usa Inc
2.1 DosageGeneral Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.
The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 25% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 25%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 25% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 25% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 25% may be given for every 1,000 mL of ascitic fluid removed.
Ovarian Hyperstimulation Syndrome
In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 25% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]
Adult Respiratory Distress Syndrome (ARDS)
In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]
Induction of Diuresis in Patients with Acute Nephrosis
In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.
Hemolytic Disease of the Newborn
ALBUMIN (HUMAN) 25% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]
2.2 AdministrationIntravenous use only.
Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.
Do not dilute with sterile water for injection.
Do not use solutions of ALBUMIN (HUMAN) 25% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 25% is not required.
The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.
If large volumes (greater than or equal to 1500 ml) are administered, the product should be warmed to room temperature before use.
-
Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
Albumin | Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
2.1 DosageGeneral Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 5% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g of ALBUMIN (HUMAN) 5% should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 5%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 5% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 5% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 5% may be given for every 1,000 mL of ascitic fluid removed.
2.2 AdministrationIntravenous use only.
Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.
Do not dilute with sterile water for injection.
Do not use solutions of ALBUMIN (HUMAN) 5% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 5% is not required.
The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.
If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
-
Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
Albumin | Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
2.2 DosageGeneral Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.
The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 20% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 20%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 20% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 20% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 20% may be given for every 1,000 mL of ascitic fluid removed.
Ovarian Hyperstimulation Syndrome
In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 20% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]
Adult Respiratory Distress Syndrome (ARDS)
In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]
Induction of Diuresis in Patients with Acute Nephrosis
In adults, a dose of 25 g of ALBUMIN (HUMAN) 20% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.
Hemolytic Disease of the Newborn
In newborns, ALBUMIN (HUMAN) 20% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]
2.1 AdministrationIntravenous use only.
Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.
Do not dilute with sterile water for injection.
Do not use solutions of ALBUMIN (HUMAN) 20% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 20% is not required.
The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.
If large volumes (greater than 1500 ml) are administered, the product should be warmed to room temperature before use.
-
Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
Albumin | Octapharma Pharmazeutika Produktionsgesellschaft M.b.h.
2.1 DosageGeneral Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.
The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 25% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 25%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 25% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 25% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 25% may be given for every 1,000 mL of ascitic fluid removed.
Ovarian Hyperstimulation Syndrome
In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 25% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [ 7 ]
Adult Respiratory Distress Syndrome (ARDS)
In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [ 5 ]
Induction of Diuresis in Patients with Acute Nephrosis
In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.
Hemolytic Disease of the Newborn
ALBUMIN (HUMAN) 25% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [ 6 ]
2.2 AdministrationIntravenous use only.
Prior to administration, parenteral drug products should be inspected visually for turbidity and discoloration, whenever solution and container permit.
Do not dilute with sterile water for injection.
Do not use solutions of ALBUMIN (HUMAN) 25% which are cloudy or have deposits. Once the infusion container has been opened the contents should be used immediately. Discard the unused portion. Filtration of ALBUMIN (HUMAN) 25% is not required.
The infusion rate should be adjusted according to the individual circumstances and the indication. In plasma exchange during paracentesis, the infusion rate may be higher and should be adjusted to the rate of removal.
If large volumes (greater than or equal to 1500 ml) are administered, the product should be warmed to room temperature before use.
![Albumin (Human) (Albumin Human) Solution [Octapharma Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bfea0d08-0e7f-a057-7b70-49b909b05a6a&name=img0002.jpg)
![Albumin (Human) (Albumin Human) Solution [Octapharma Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=07734008-9dd3-b006-0825-65147c58e1ac&name=img0002.jpg)
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