What is Albumin-GRIFOLS?
Albumin-GRIFOLS (human) injection is used to treat low blood volume (hypovolemia). It is also used to treat low Albumin-GRIFOLS levels in the blood (hypoalbuminemia) caused by: not enough Albumin-GRIFOLS produced by the body (eg, malnutrition, burns, major injury, infections), excessive breakdown of Albumin-GRIFOLS (eg, burns, major injury, pancreatitis), loss of Albumin-GRIFOLS from the body (eg, bleeding, excessive kidney excretion, burn exudates), or redistribution of Albumin-GRIFOLS from the body (eg, major surgery, inflammatory conditions).
Albumin-GRIFOLS (human) injection is also used to treat hypoalbuminemia in patients with severe injuries, infections, or pancreatitis (swelling of the pancreas) that cannot be quickly reversed and when nutritional supplements have been given but did not work well. It is also used together with crystalloid treatment to correct lower osmotic pressure in the blood and to replace protein loss caused by severe burns after the first 24 hours.
Albumin-GRIFOLS (human) injection is used as a priming fluid during cardiopulmonary bypass surgery.
Flexbumin® 25% is used when hypovolemia is long-standing and hypoalbuminemia exists along with enough hydration, or fluid swelling (edema). It is also used together with other medicines (eg, water pill) to treat fluid swelling in the lungs (interstitial pulmonary edema) and hypoproteinemia (low protein levels in the blood) in patients with adult respiratory distress syndrome (ARDS). Flexbumin® 25% is also used to treat swelling in patients with severe nephrosis who are receiving steroids or a water pill. It is also used to treat hemolytic disease of the newborn (HDN) in babies.
Albumin-GRIFOLS human is to be given only by or under the direct supervision of your doctor.
Albumin-GRIFOLS indications
Hypovolemia
Albumin-GRIFOLS (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-GRIFOLS solutions should be used. [ ]
Hypoalbuminemia
For subjects with hypoalbuminemia who are critically ill and/or are bleeding actively, Albumin-GRIFOLS (HUMAN) 20% infusions may be indicated. [ ] When Albumin-GRIFOLS deficit is the result of excessive protein loss, the effect of administration of Albumin-GRIFOLS (Human) 20% will be temporary unless the underlying disorder is reversed.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites (Treatment Adjunct)
Albumin-GRIFOLS (Human) 20% may be used to maintain cardiovascular function following the removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites. [ ]
Ovarian Hyperstimulation Syndrome (OHSS)
Albumin-GRIFOLS (Human) 20% may be used as a plasma expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome (OHSS). [7, 8]
Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)
Albumin-GRIFOLS (Human) 20% infusions may be indicated in conjunction with diuretics to correct the fluid volume overload associated with ARDS. [ ]
Acute Nephrosis (Treatment Adjunct)
Albumin-GRIFOLS (Human) 20% may be used to treat edema in patients with acute nephrosis who are refractory to cyclophosphamide and corticosteroid therapy. [ ]
Hemolytic Disease of the Newborn (HDN)
Albumin-GRIFOLS (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. [ ]
How should I use Albumin-GRIFOLS?
Use Albumin-GRIFOLS (human) as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Albumin-GRIFOLS (human) is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Albumin-GRIFOLS (human) at home, carefully follow the injection procedures taught to you by your health care provider.
- If Albumin-GRIFOLS (human) contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
- Use Albumin-GRIFOLS (human) with the administration set that came with it. Be sure the filter is used. After opening, administration must be started within 4 hours. Discard any bottles that have been open for more than 4 hours. Do not save partially used bottles for later use.
- Do not infuse Albumin-GRIFOLS (human) faster than the rate specified by your doctor.
- Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
- If you miss a dose of Albumin-GRIFOLS (human), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once. If more than one dose is missed, contact your doctor or pharmacist.
Ask your health care provider any questions you may have about how to use Albumin-GRIFOLS (human).
Uses of Albumin-GRIFOLS in details
Use: Labeled Indications
Acute respiratory distress syndrome (25% solution only): To correct interstitial pulmonary edema and hypoproteinemia associated with acute respiratory distress syndrome in conjunction with diuretics.
Cirrhotic ascites, adjunct treatment: To maintain intravascular volume following removal of large-volume paracentesis in cirrhotic patients.
Erythrocyte resuspension: To avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes or previously frozen or washed red cells.
Hypovolemia: Plasma volume expansion and maintenance of intravascular volume in the emergency treatment of hypovolemia (with or without shock).
Neonatal hemolytic disease: Binds and detoxifies unconjugated bilirubin in severe hemolytic disease of the newborn during exchange transfusion.
Nephrosis (acute), adjunct: Treatment of edema in patients with acute nephrosis in combination with diuretics.
Ovarian hyperstimulation syndrome, treatment (25% solution only): As a plasma volume expander in fluid management for the treatment of severe ovarian hyperstimulation syndrome.
Off Label Uses
Cirrhosis (in combination with diuretics to facilitate diuresis)
Data from an unblinded, randomized, controlled study supports the use of Albumin-GRIFOLS in the treatment of cirrhosis (in combination with diuretics) to facilitate diuresis. Additional trials may be necessary to further define the role of Albumin-GRIFOLS in this condition.
Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, Albumin-GRIFOLS given for cirrhosis (in combination with diuretics) to facilitate diuresis is possibly effective, but further studies are needed before Albumin-GRIFOLS can be recommended for the management of this condition.
Spontaneous bacterial peritonitis (treatment)
American Association for the Study of Liver Diseases and European Association for the Study of the Liver clinical practice guidelines recommend Albumin-GRIFOLS in conjunction with antibiotic therapy for treatment of cirrhotic patients with SBP. In controlled trials, the addition of Albumin-GRIFOLS to antibiotic therapy was associated with significant reductions in incidences of renal impairment and mortality.
Volume expansion in dehydrated, mildly hypotensive patients with cirrhosis
Based on the American Association for the Study of Liver Diseases (AASLD) guidelines for the management of adult patients with ascites due to cirrhosis, Albumin-GRIFOLS given for volume expansion in dehydrated, mildly hypotensive patients with cirrhosis is effective and recommended in the management of this condition.
Albumin-GRIFOLS dosage
Usual Adult Dose for Peritonitis
Albumin-GRIFOLS 5%:
Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate.
Albumin-GRIFOLS 25%:
Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albumin-GRIFOLS 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albumin-GRIFOLS 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.
Usual Adult Dose for Shock
Albumin-GRIFOLS 5%:
Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate.
Albumin-GRIFOLS 25%:
Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albumin-GRIFOLS 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albumin-GRIFOLS 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.
Usual Adult Dose for Pancreatitis
Albumin-GRIFOLS 5%:
Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate.
Albumin-GRIFOLS 25%:
Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albumin-GRIFOLS 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albumin-GRIFOLS 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.
Usual Adult Dose for Burns - External
Albumin-GRIFOLS 5%:
Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate.
Albumin-GRIFOLS 25%:
Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albumin-GRIFOLS 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albumin-GRIFOLS 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.
Usual Adult Dose for Hypoproteinemia
Albumin-GRIFOLS 5%:
Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate.
Albumin-GRIFOLS 25%:
Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albumin-GRIFOLS 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albumin-GRIFOLS 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.
Usual Adult Dose for Postoperative Albumin-GRIFOLS Loss
Albumin-GRIFOLS 5%:
Initial dose: 250 or 500 mL IV at a rate of 1 to 2 mL per minute in the absence of overt shock. The capacity of the administration set is the only limit in the exsanguinated patient. The rate of infusion and total volume administered are determined by the condition and response of the patient. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate.
Albumin-GRIFOLS 25%:
Initial dose: The patient may require 200 to 300 mL IV to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of Albumin-GRIFOLS 25% should not be given faster than 100 mL IV over 30 to 45 minutes to avoid circulatory overload. If slower administration is desired, 200 mL of Albumin-GRIFOLS 25% may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL an hour IV.
Usual Pediatric Dose for Peritonitis
Albumin-GRIFOLS 5%:
Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.
Usual Pediatric Dose for Shock
Albumin-GRIFOLS 5%:
Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.
Usual Pediatric Dose for Pancreatitis
Albumin-GRIFOLS 5%:
Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.
Usual Pediatric Dose for Burns - External
Albumin-GRIFOLS 5%:
Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.
Usual Pediatric Dose for Hypoproteinemia
Albumin-GRIFOLS 5%:
Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.
Usual Pediatric Dose for Postoperative Albumin-GRIFOLS Loss
Albumin-GRIFOLS 5%:
Initial dose: 10 to 15 mL per pound (4.5 to 6.8 mL per kg) of body weight IV is usually adequate accompanied by close surveillance of the child.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
When undiluted Albumin-GRIFOLS 25% solution is administered to patients with normal blood volume, the rate of infusion should be slow enough (1 mL per minute) to prevent too rapid expansion of plasma volume.
The amount of Albumin-GRIFOLS and duration of therapy in the treatment of shock should be based on the responsiveness of the patient as indicated by blood pressure, degree of pulmonary congestion, and hematocrit. The initial dose may be followed by additional Albumin-GRIFOLS within 15 to 30 minutes if the response is inadequate. If there is continued loss of protein, it may be desirable to give packed red blood cells.
In the treatment of burns, an optimal regimen using Albumin-GRIFOLS, crystalloids, electrolytes, and water has not been established. Suggested therapy during the first 24 hours includes administration of large volumes of crystalloid solution to maintain an adequate plasma volume. Continuation of therapy beyond 24 hours usually requires more Albumin-GRIFOLS and less crystalloid solution to prevent marked hemoconcentration and maintain electrolyte balance. Duration of treatment varies depending upon the extent of protein loss through renal excretion, denuded areas of skin, and decreased Albumin-GRIFOLS synthesis. Attempts to raise the Albumin-GRIFOLS level above 4 g/100 mL may only result in an increased rate of catabolism.
Precautions
When dosing Albumin-GRIFOLS, the 5% solution should be used in hypovolemic patients or intravascularly-depleted patients and the 25% solution should be used in patients in whom fluid and sodium intake is restricted.
Additional fluids should accompany or follow the administration of Albumin-GRIFOLS if the patient is dehydrated.
Administration of large quantities of Albumin-GRIFOLS should be supplemented with or replaced by packed red blood cells to combat the relative anemia which would follow such use.
Albumin-GRIFOLS should be administered with caution to patients with low cardiac reserve or with no Albumin-GRIFOLS deficiency because a rapid increase in plasma volume may cause circulatory compromise (e.g., hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired: 200 mL of Albumin-GRIFOLS solution may be mixed with 300 mL of 10% dextrose solution and administered at a rate of 10 g of Albumin-GRIFOLS (100 mL) per hour.
No clinical studies using Albumin-GRIFOLS 25% have been conducted in pediatric patients. Safety and effectiveness in pediatric patients (less than 18 years old) have not been established. However, extensive experience suggests that children respond to Albumin-GRIFOLS 25% in the same manner as adults.
Dialysis
Data not available
Other Comments
The manufacturer does not recommend diluting Albumin-GRIFOLS 5% solution.
Albumin-GRIFOLS 25% may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration (200 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma).
Albumin-GRIFOLS, unlike whole blood or plasma, is considered free of the danger of homologous serum hepatitis. Albumin-GRIFOLS may be given in conjunction with other parenteral fluids such as saline, dextrose, or sodium lactate. It is convenient to use since no cross-matching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.
Albumin-GRIFOLS human solution is compatible with whole blood or packed red blood cells as well as the usual electrolyte and carbohydrate solutions intended for intravenous use. Albumin-GRIFOLS 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 patient.
Albumin-GRIFOLS interactions
See also:
What other drugs will affect Albumin-GRIFOLS?
There are no known significant interactions.
Albumin-GRIFOLS side effects
See also:
What are the possible side effects of Albumin-GRIFOLS?
General
The most serious events are anaphylactic shock, circulatory failure, cardiac failure, and pulmonary edema.
The most common adverse events are anaphylactoid type of reactions.
Adverse reactions for Albumin-GRIFOLS (Human) 20% normally resolve when the infusion rate is slowed down or the infusion is stopped. In case of severe reactions, the infusion should be stopped and appropriate treatment should be initiated.
Clinical Studies Experience
No clinical studies were done using Albumin-GRIFOLS (Human) 20%
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Albumin-GRIFOLS (HUMAN) (any strength). Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency.
Table 1 Adverse reactions observed for Albumin-GRIFOLS HUMAN (any strength) during post-marketing phase (in decreasing order of severity)
No drug interaction studies have been conducted.
Albumin-GRIFOLS contraindications
See also:
What is the most important information I should know about Albumin-GRIFOLS?
Hypersensitivity to Albumin-GRIFOLS or any component of the formulation; severe anemia, heart failure; patients at risk of volume overload (eg, patients with renal insufficiency, severe anemia, stabilized chronic anemia, or heart failure); dilution with sterile water for injection (may cause hemolysis or acute renal failure)
Active ingredient matches for Albumin-GRIFOLS:
| Unit description / dosage (Manufacturer) | Price, USD |
| ALBUMIN-GRIFOLS 20% PREFILLED SYRINGE 1 packet / 100 ML prefilled syringe each (Bharat Serums & Vaccines Ltd) | $ 84.34 |
List of Albumin-GRIFOLS substitutes (brand and generic names): | |
| Albuked | |
| Albuked 25 | |
| Albumar (Mexico) | |
| Albumer (Sweden) | |
| Albumin (Bosnia & Herzegowina, India) | |
| Injectable; Injection; Albumin Human 10% | |
| Injectable; Injection; Albumin Human 5% | |
| Injectable; Injection; Albumin Human 20% | |
| Injectable; Injection; Albumin Human 25% | |
| ALBUMIN (BAYER) | |
| ALBUMIN 20% INJECTION 1 vial / 1 injection each (Bayer Pharmaceuticals Pvt Ltd) | $ 19.58 |
| Albumin (human) | |
| ALBUMIN GRIFOLS | |
| Albumyn (Mexico) | |
| Albuprime | |
| Albuprime 20% Injection (Intas Pharmaceuticals Ltd) | $ 0.54 |
| Alburel-T | |
| Alburel-T 20gm Injection (Reliance Life Sciences) | $ 0.55 |
| Albusol (South Africa) | |
| Albutas | |
| Albutas 20% Injection (Intas Pharmaceuticals Ltd) | $ 0.51 |
| Beribumin (Brazil) | |
| Blaubumin (Brazil) | |
| Blauinfusion (Brazil) | |
| Egg Plus (Israel) | |
| Endalbumin (Italy) | |
| Green-A KGCC (Brazil) | |
| Haimalbumin (Italy) | |
| Hi-Bumin (Mexico) | |
| HUMAN ALBUMIN (SERUM) | |
| HUMAN ALBUMIN 5% INFUSION 1 bottle / 100 ML infusion each (Serum Institute Of India Ltd) | $ 41.79 |
| HUMAN ALBUMIN(BHARAT SERUM) | |
| HUMAN ALBUMIN 20% INFUSION 1 bottle / 100 ML infusion each (Bharat Serums & Vaccines Ltd) | $ 60.24 |
| Humanalbumin ZLB | |
| Infosan (Norway) | |
| Infoson (Sweden) | |
| Medway (Japan) | |
| OPV (India) | |
| OPV Drops / NA / 10 x 10 units (Aventis pasteur) | $ 8.77 |
| 10's (Aventis pasteur) | $ 8.77 |
| OPV INJECTION 1 vial / 1 injection each (Aventis pasteur) | $ 2.77 |
| Pilmolite (Brazil) | |
| Probialbumin (Mexico) | |
| Relab (Vietnam) | |
| Relab 20 % x 1 Bottle 100 mL | |
| Relab 20 % x 1 Bottle 50 mL | |
| Rhodalbumin (Germany) | |
| Seralbuman (Italy) | |
| Vanderbumin (Mexico) | |
Reviews
The results of a survey conducted on ndrugs.com for Albumin-GRIFOLS are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Albumin-GRIFOLS. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
