4.1.1 Hypovolemia
For restoration and maintenance of circulating blood volume where hypovolemia is
demonstrated and colloid use is appropriate. When hypovolemia is long standing and
hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin
solutions should be used.
Acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia
can be present. Albutein® 20% can be used in such cases.
Albutein® 20% may be of value in the treatment of shock or hypotension in renal dialysis
patients.
4.1.2 Cardiopulmonary Bypass Procedures (Treatment Adjunct)
Preoperative dilution of blood using albumin and crystalloid can be used in
cardiopulmonary bypass procedures. Albumin also may be used in the priming fluid.
4.1.3 Acute Nephrosis (Treatment Adjunct)
Albutein® 20% may be used to treat peripheral edema in patients with acute nephrosis
who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.
4.1.4 Hypoalbuminemia
Abutein® 20% may be indicated for subjects with hypoalbuminemia who are critically ill
and/or actively bleeding. When albumin deficit is the result of excessive protein loss, the
effect of Albutein® 20% administration will be temporary unless the underlying disorder
is reversed. Septic patients and patients undergoing major surgery may lose more than
half of their circulating plasma volume. Treatment with Albutein® 20% may be of value
in such cases, especially when plasma colloid oncotic pressure is abnormally low.
In the first 24 hours after thermal injury, large volumes of crystalloids are infused to
restore the depleted extracellular fluid volume. Beyond 24 hours, Albutein® 20% can be
used to maintain plasma colloid osmotic pressure. Protein loss from the third space due to
infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require
treatment with an infusion of albumin.

4.1.5 Ovarian Hyperstimulation Syndrome
Albutein® 20% may be used as a plasma volume expander in fluid management relating to
severe forms of ovarian hyperstimulation syndrome.
4.1.6 Neonatal hyperbilirubinemia
Albutein® 20% is indicated for the treatment of neonatal hyperbilirubinemia. It may be
used prior to or during an exchange procedure in an attempt to bind free bilirubin and
enhance its excretion.
4.1.7 Adult Respiratory Distress Syndrome (ARDS) (Treatment Adjunct)
Albutein® 20% infusions may be indicated in conjunction with diuretics to correct fluid
overload and hypoproteinemia associated with ARDS.
4.1.8 Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic
Ascites (Treatment Adjunct)
Albutein® 20% may be used to maintain cardiovascular function following removal of
large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.

For Intravenous Use Only
4.2.1 Dosage
Adjust the concentration, dosage and infusion rate of the albumin preparation to the
patient’s individual requirements.
The dose required depends on the patient’s body weight, severity of injury/illness and on
continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma
albumin levels, to determine the dose required.

4.4.1 Hypersensitivity
Suspicion of allergic or anaphylactic reactions requires immediate discontinuation of the
infusion and implementation of appropriate medical treatment.
4.4.2 Hypervolemia/Hemodilution
Albutein® 20% should be administered with caution to patients with low cardiac reserve.
Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients
should be closely monitored for signs of increased venous pressure.
A rapid rise in blood pressure following infusion necessitates careful observation of
injured or postoperative patients to detect and treat severed blood vessels that may not
have bled at a lower pressure.
Hypervolemia may occur if the dosage and rate of infusion are not adjusted to the
patient’s volume status. At the first clinical signs of cardiovascular overload (headache,
dyspnea, jugular venous distention, increased blood pressure), the infusion must be
slowed or stopped immediately.
Use albumin with caution in conditions where hypervolemia and its consequences or
hemodilution could represent a special risk to the patient. Examples of such conditions
are:
• Decompensated heart failure
• Hypertension
• Esophageal varices
• Pulmonary edema

• Hemorrhagic diathesis
• Severe anemia
• Renal and post-renal anuria
4.4.3 Dehydration
Patients with marked dehydration require administration of additional fluids. Albutein®
20% may be administered with the usual dextrose and saline intravenous solutions.
However, solutions containing protein hydrolysates or alcohol must not be infused
through the same administration set in conjunction with Albutein® 20% since these
combinations may cause the proteins to precipitate.
The colloid-osmotic effect of human albumin 20% is approximately four times that of
blood plasma. Therefore, when concentrated albumin is administered, care must be taken
to assure adequate hydration of the patient. Patients should be monitored carefully to
guard against circulatory overload and hyperhydration. Patients with marked dehydration
required administration of additional fluids.
4.4.4 Electrolyte Imbalance
20% - 25% human albumin solutions are relatively low in electrolytes compared to 4% -
5% human albumin solutions. Monitor regularly the electrolyte status of the patient and
take appropriate steps to restore or maintain the electrolyte balance when albumin is
administered.
4.4.5 Coagulation Abnormalities
Regular monitoring of coagulation and hematology parameters is necessary if
comparatively large volumes are to be replaced. Care must be taken to ensure adequate
substitution of other blood constituents (coagulation factors, electrolytes, platelets and
erythrocytes).
4.4.6 Laboratory Monitoring
Monitor regularly hemodynamic parameters during administration of Albutein® 20%; this
may include:
• Arterial blood pressure and pulse rate
• Central venous pressure
• Pulmonary artery occlusion pressure
• Urine output
• Electrolytes

• Hematocrit/hemoglobin
4.4.7 Application Precautions
Albutein® 20% must not be diluted with sterile water for injection as this may cause
hemolysis in recipients. The product can be diluted in an isotonic solution (e.g., 5%
dextrose in water or 0.9% sodium chloride) [see Posology and Method of Administration

4.4.8 Transmissible Infectious Agents
Albumin is a derivative of human blood. Based on effective donor screening and product
manufacturing processes, it carries an extremely remote risk for transmission of viral
diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also
considered extremely remote. No cases of transmission of viral diseases or CJD have been
identified for Albutein® 20%.
Solutions of Albutein® 20% should not be used if they appear turbid or if there is sediment
in the bottle. Do not begin administration more than 4 hours after the container has been
entered. Discard unused portion.

No specific interactions of human albumin with other medicinal products are known.

Pregnancy Category C: Animal reproduction studies have not been conducted with
Albutein® 20%. It is also not known whether Albutein® 20% can cause fetal harm when
administered to a pregnant woman or can affect reproductive capacity. Albutein® 20%
should be given to a pregnant woman only if clearly needed.
Nursing Mothers: There is no human or animal data on the use of Albutein® 20% for
lactating women. Use only if clearly needed.

Albutein® 20% has not been reported to affect the ability to drive or operate machines.

a. Summary of the safety profile

The most serious adverse reactions are anaphylactic shock, heart failure and
pulmonary edema.
The most common adverse reactions are anaphylactoid type reactions.
The most common adverse reactions include fever and chills, rash, nausea,
vomiting, tachycardia and hypotension. Adverse reactions to Albutein® 20%
normally resolve when the infusion rate is slowed or the infusion is stopped.
Should an adverse reaction occur, slow or stop the infusion for a short period of
time which may result in the disappearance of the symptoms. In case of severe
reactions, the infusion is stopped and appropriate treatment initiated.
Albutein® 20%, particularly if administered rapidly, may result in vascular
overload with resultant pulmonary edema.
b. Tabulated summary of adverse reactions
Because adverse reactions are reported voluntarily post-approval from a
population of uncertain size, it is not always possible to reliably estimate their
frequency or to establish a causal relationship to product exposure. The following
adverse reactions have been identified during post approval use of Albutein® 20%,
in decreasing order of significance:
• Anaphylactic shock
• Heart failure
• Pulmonary edema
• Hypotension
• Tachycardia
• Vomiting
• Urticaria
• Rash
• Headache
• Chills
• Fever
• Flushing
• Nausea
c. Description of selected adverse reactions
The most serious adverse reactions are anaphylactic shock, heart failure and
pulmonary edema.
The most common adverse reactions are anaphylactoid type reactions.

Adverse reactions to Albutein® 20% normally resolve when the infusion rate is
slowed or the infusion is stopped.
In the case of severe reactions, the infusion is stopped and appropriate treatment
initiated.
d. Pediatric population
No human or animal data. Use only if clearly needed.
e. Other special population(s)
No human or animal data. Use only if clearly needed.
To report SUSPECTED REACTIONS, contact Grifols at +1-323-225-2221.
To report any side effect(s):
• Saudi Arabia:
- The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-
2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

Hypervolemia may occur if the dosage and rate of infusion are too high. At the first
clinical signs of cardiovascular overload (headache, dyspnea, jugular vein congestion),
or increased blood pressure, raised central venous pressure and pulmonary edema, the
infusion should be stopped immediately and the patient’s hemodynamic parameters
carefully monitored.

Pharmacotherapeutic group: Blood substitutes and plasma protein fractions,
Anatomical Therapeutic Chemical (ATC) code: B05AA01.
Human albumin accounts quantitatively for more than half of the total protein in the
plasma and represents about 10% of the protein synthesis activity of the liver. Physicochemical data: human albumin 4 to 5% is mildly hypooncotic to normal plasma.
Albutein® 20% has a corresponding hyperoncotic effect.
The most important physiological functions of albumin result from its contribution to
oncotic pressure of the blood and transport function. Albumin stabilizes circulation
blood volume and is a carrier of hormones, enzymes, medicinal products and toxins.

Under normal conditions, the total exchangeable albumin pool is 4 - 5 g/kg body
weight, of which 40 - 45% is present intravascularly and 55 - 60% in the extravascular
space. Increased capillary permeability will alter albumin kinetics and abnormal
distribution may occur in conditions such as severe burns or septic shock.
Under normal conditions, the average half-life of albumin is about 19 days. The balance
between synthesis and breakdown is normally achieved by feed-back regulation.
Elimination is predominantly intracellular and due to lysosome proteases.
In healthy subjects, less than 10% of infused albumin leaves the intravascular
compartment during the first 2 hours following infusion. There is considerable
individual variation in the effect on plasma volume.
In some patients the plasma volume can remain increased for some hours. However, in
critically ill patients, albumin can leak out of the vascular space in substantial amounts
at an unpredictable rate.

Human albumin is a normal constituent of human plasma and acts like physiological
albumin.
In animals, single dose toxicity testing is of little relevance and does not permit the
evaluation of toxic or lethal doses or of a dose-effect relationship.
Repeated dose toxicity testing is impracticable due to the development of antibodies to
heterologous protein in animal models.
To date, Albutein® 20% has not been reported to be associated with embryo-fetal
toxicity, oncogenic or mutagenic potential.
No signs of acute toxicity have been described in animal models.

Albutein® 20% must not be mixed with other medicinal products (except the
recommended diluents), whole blood and packed red cells.
Do not administer protein hydrolysates or alcohol via the same administration set used
for Albutein® 20%. It may cause the proteins to precipitate.
Albutein® 20% must not be diluted with sterile water for injection as this may cause
hemolysis in recipients. The product can be diluted in an isotonic solution (e.g., 5%
Dextrose in Water or 0.9% sodium chloride).

Store Albutein® 20% at temperatures not exceeding 30 C.
Protect from freezing

Albutein® 20% is supplied in: 50 mL, clear, Type II glass vial containing 10 g of albumin

Directions for Use:
When an Administration Set is Used
Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber
stopper with suitable germicidal solution, being sure to remove any excess. Observe
aseptic technique and prepare sterile intravenous equipment as follows:
1. Close clamp on administration set.
2. With bottle upright, squeeze drip chamber, thrust piercing pin straight through
stopper center. Do not twist or angle.
3. Immediately invert bottle, release drip chamber to automatically establish proper
fluid level in drip chamber (half full).
4. Attach infusion set to administration set, open clamp and allow solution to expel air
from tubing and needle, then close clamp.
5. Make venipuncture and adjust flow.
6. Discard all administration equipment after use. Discard any unused contents.
When an Administration Set is Not Used
Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber
stopper with suitable germicidal solution, being sure to remove any excess. Observe
aseptic technique and prepare sterile intravenous equipment as follows:
1. Using aseptic technique, attach filter needle to a sterile disposable plastic syringe.
2. Insert filter needle into Albutein® 20%.
3. Aspirate Albutein®20% from the vial into the syringe.
4. Remove and discard the filter needle from the syringe.
5. Attach desired size needle to syringe.
6. Discard all administration equipment after use. Discard any unused contents.