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ALBUSOL 4% (Solution for IV Infusion)
ALBUSOL 4% (Solution for IV Infusion)
SCHEDULING STATUS
S4
PROPRIETARY NAME
(and dosage form):
ALBUSOL 4% (Solution for IV Infusion)
COMPOSITION
DESCRIPTIVE NAME: HUMAN PLASMA ALBUMIN 4%
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.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection, testing of plasma pools by NAT (Nucleic Acid Amplification Technology) for HCV and HIV RNA, and the inclusion of effective manufacturing steps for the inactivation / removal of viruses.
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 10hours at 60ºC, a process that has been validated and shown to be effective against HIV, HCV and HBV viruses.
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
Albusol 4% is a sterile solution containing 4% m/v (8g/200mL) human plasma albumin. It is stabilised with 0,16mmol sodium caprylate per gram protein and 3% m/v dextrose.
The solution is at pH7. 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.
PHARMACOLOGICAL CLASSIFICATION
A 30.3 Biologicals (Blood fractions)
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. It also has a transport function and is a carrier of hormones, enzymes, medicinal products and toxins.
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 200mL 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 3hours after administration.
INDICATIONS
Albusol 4% is indicated in the following instances
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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. |
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Burns: Use for severe burns (>15% body surface area) after the first 24 hours if hypoproteinaemia develops and/or to maintain plasma volume. |
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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 renal 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. |
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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:
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Decompensated cardiac insufficiency |
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Hypertension |
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Oesophageal varices |
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Pulmonary oedema |
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Haemorrhagic diathesis |
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Severe anaemia |
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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).
WARNINGS:
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
INTERACTIONS
No specific interactions of Albusol 4% with other medicinal products are known.
PREGNANCY AND LACTATION
The safety of Albusol 4% 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.
DOSAGE AND DIRECTIONS FOR USE
Albumin solutions need not be given through a filter. No compatibility testing (crossmatching) need be performed since ABO blood group antibodies are not 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.
If human plasma albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:
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arterial blood pressure and pulse rate |
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central venous pressure |
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pulmonary artery wedge pressure |
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urine output |
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electrolytes |
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haemoglobin |
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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. |
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Paediatric dosage: Approximately 2,5 to 12,5 grams in total or 0,5 to 1gram 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. |
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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. |
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Hypoproteinaemia |
Adult dosage: 50 to 75 grams administered IV |
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Ascites |
Dosage as per hypovolaemia. |
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Gastrointestinal: Less frequent: Nausea, vomiting, increased salivation
Skin and appendages: More frequent: Urticaria
Autonomic nervous system: Less frequent: Flushing
Body as a whole/ General disorders:
More frequent: Chills, febrile reactions, fever
Rare: Acute allergic shock.
Cardiovascular disorders(general):
Rare: 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.
Special Precautions
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.
In the case of a diabetic patient, the serum glucose should be monitored as Albusol 4% contains dextrose.
It is strongly recommended that every time that you administer Albusol 4% to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
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 (headache, dyspnoea, jugular vein congestion) 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.
IDENTIFICATION
A clear, almost colourless to amber solution.
PRESENTATION
200mL: Albusol 4% solution in a clear glass bottle with a rubber stopper and an aluminium closure.
STORAGE DIRECTIONS
Store below 25ºC.
Protect from light.
Keep out of reach of children.
Discard any unused material.
REGISTRATION NUMBER
T/30.3/738
NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
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PRIVATE BAG X9043 |
10 EDEN ROAD |
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PINETOWN |
PINETOWN |
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3600 |
3610 |
Telephone: (031) 719 6789
Telefax: (031) 708 5614
DATE OF PUBLICATION OF THIS PACKAGE INSERT
09/2006
2006/06P46
Updated on this site: June 2010
Source: Pharmaceutical Industry
Disclaimer:
Please note that the National 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 (0)31 714 6700or +27 (0)82 870 3705 or +27 (0)82 895 0056.
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