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ALBUSOL 4% (Solution for IV Infusion)

REGISTRATION NUMBER
T/30.3/738

PROPRIETARY NAME
(and dosage form):

ALBUSOL 4% (Solution for IV Infusion)

DESCRIPTIVE NAME OF MEDICINE
Human plasma albumin 4%

PHARMACOLOGICAL CLASSIFICATION
A 30.3 Biologicals (Blood fractions)

SCHEDULING STATUS
S4

COMPOSITION
Albusol 4% is prepared from pooled human plasma of volunteer non-remunerated blood donors. Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to the hepatitis C virus and for antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Albusol 4% solution is prepared by cold ethanol fractionation to further reduce the risk of viral transmission.
Albusol 4% solution is sterilised by filtration and then pasteurised by heating for 10 hours at 60°C, a process that inactivates viruses, including HIV and hepatitis viruses.
Albusol 4% is a sterile solution containing 4% m/v (8g / 200 mL, 16g / 400 mL) human plasma albumin. It is stabilised with 0,16 mmol sodium caprylate per gram protein and 3% m/v dextrose.
The solution is at pH 7. Each litre of solution contains less than 130 mmol sodium ions, less than 2 mmol potassium ions and less than 4 mmol citrate ions.
Albusol 4% contains no antimicrobial agent or preservative.

IDENTIFICATION
A clear, almost colourless to amber solution.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Albumin is the dynamic protein in plasma responsible for maintaining the plasma colloid osmotic pressure thus regulating intravascular blood volume.
Human albumin 4% is osmotically and oncotically equivalent to plasma. The oncotic effect of 200 mL of this solution is approximately equal to that of 200 mL of normal human plasma.
Less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. As a result the circulating volume will increase from 1 to 3 hours after administration.

INDICATIONS
Albusol 4% is indicated in the following instances

•	Hypovolaemic shock: Albusol 4% is indicated in the treatment of hypovolaemic shock associated with blood loss, trauma and surgical procedures. Albumin solutions are an accepted form of resuscitation, although crystalloids are the initial fluid of choice.
•	Burns: Use for severe burns (>15% body surface area) after the first 24 hours if hypoproteinaemia develops and/or to maintain plasma volume.
•	Hypoproteinaemia: Albusol 4% is indicated in the treatment of hypoproteinaemia caused by a loss of plasma proteins. Loss of plasma proteins may occur through decreased absorption in gastrointestinal disorders, inadequate synthesis in chronic liver disease or excessive urinary catabolism in chronic liver disease. This loss of proteins leads to oedema, secondary to a fluid shift from the intravascular space to the interstitium, and a compensatory increase in salt and water retention. Albumin serves to restore colloid osmotic pressure and in, conjunction with a diuretic, promotes diuresis.
•	Ascites: Albusol 4% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid.

CONTRA-INDICATIONS
A history of allergic reaction to albumin preparations
Infusion of albumin solutions is contra-indicated in patients in whom hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a special risk for the patient. Examples of such conditions are

-	Decompensated cardiac insufficiency
-	Hypertension
-	Oesophageal varices
-	Pulmonary oedema
-	Haemorrhagic diathesis
-	Severe anaemia
-	Renal and post-renal anuria

(see "SIDE EFFECTS AND SPECIAL PRECAUTIONS" and "KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT").
In burns and in severely shocked patients, administration of albumin solutions should be deferred until the phase of maximal capillary permeability to albumin molecules is over (i.e. after the first 24 hours).

DOSAGE AND DIRECTIONS FOR USE
Albumin solutions need not be given through a filter. No compatibility testing (crossmatching) need be performed since no ABO blood group antibodies are present.
Albusol 4% is given by intravenous infusion at a rate of about 1 mL per minute. The rate of infusion and the total volume of albumin administered ultimately must be guided by the haemodynamic response of the patient and the clinical indication for which it has been prescribed.

Dosage guidelines:
The following doses are included as a guide only. The doctor should determine appropriate therapy after clinical assessment of the patient. Serum albumin values alone should not be used to determine dosage.

Hypovolaemia	Adult dosage: Approximately 25 grams administered as an IV infusion. If adequate clinical response is not achieved within 15 to 30 minutes, an additional dose may be given. Paediatric dosage: Approximately 2,5 to 12,5 grams in total or 0,5 to 1 gram per kg of body mass administered as an IV infusion. If adequate clinical response is not achieved within 15 to 30 minutes, an additional dose may be given.
Burns	Adult and paediatric dosage: It is recommended that therapy begin with the administration of large volumes of crystalloid infusion to maintain plasma volume. After 24 hours, albumin may be added at an initial dose of 25 grams, with the dose adjusted thereafter.
Hypoproteinaemia	Adult dosage: 50 to 75 grams administered IV
Ascites	Dosage as per hypovolaemia.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Adverse reactions to albumin infusions include chills, nausea, vomiting, increased salivation and febrile reactions.
Infusion rate related side effects include flushing, urticaria, fever and nausea. These normally disappear when the infusion rate is slowed or the infusion stopped.
In the event of an acute allergic shock, the injection must be stopped immediately and appropriate therapy initiated
Rapid increases in circulating volume can cause vascular overload, haemodilution and pulmonary oedema. Caution is advised in patients with low cardiac reserve or cardiac insufficiency.
If large volumes are to be replaced, monitoring of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets, and erythrocytes), if indicated.
Infectious diseases due to the transmission of infectious agents cannot be totally excluded. To reduce risk, selection of donors and donations is performed. Additionally, viral inactivation procedures are included in the manufacturing process.
In the case of a diabetic patient, the serum glucose should be monitored as Albusol 4% contains dextrose.
Safety in pregnancy has not been established in controlled clinical trials. However, human albumin is a normal constituent of human blood. Therefore Albusol 4% may be used if clearly needed during pregnancy

Use within three hours of opening.
Do not use if turbid or if a precipitate is present.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion must be stopped immediately. Additionally, diuresis or cardiac output should be increased according to the severity of the clinical condition.

PRESENTATION
Pack sizes available
200 mL: Albusol 4% solution in a clear glass bottle with a rubber stopper and an aluminium closure.
400 mL: Albusol 4% solution in a clear glass bottle with a rubber stopper and an aluminium closure.

STORAGE DIRECTIONS
Store below 25°C.
Protect from light.
Keep out of reach of children.
Discard any unused material.

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATAL BIOPRODUCTS INSTITUTE
Reg. No. 94/02044/08

PRIVATE BAG X9043	10 EDEN ROAD
PINETOWN	PINETOWN
3600	3610

Telephone:         (031) 719 6789
Telefax:         (031) 708 5416

DATE OF PUBLICATION OF THIS PACKAGE INSERT
7/93

P0970 03/99

Date of Amendment: -01 March 1999
Approved: 14 June 1999

Updated on this site September 1999

Please note that the Natal Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at (+27)(+31) 719 6789 or 082 870 3705 or 082 895 0056.
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