HUMAN ALBUMIN 20% | RELIANCE ALBUREL – 100MLS

KSh13,780.00

Albumin solutions in Kenya are used for plasma volume replacement and to restore colloid osmotic pressure. They have been used in conditions such as burns, severe acute albumin loss, and acute hypovolaemic shock. They are also used as an exchange fluid in therapeutic plasmapheresis in Kenya. Concentrated albumin solutions are used in neonatal hyperbilirubinaemia associated with haemolytic disease of the newborn. HUMAN ALBUMIN can also be used for short-term management of hypoproteinaemia in hepatic disease and in diuretic-resistant patients with nephrotic syndrome but are of little value in chronic hypoproteinaemias.

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Description

Adverse Effects and Precautions

Adverse reactions to albumin infusion occur rarely and include nausea and vomiting, increased salivation, flushing, urticaria, hypotension, tachycardia, and febrile reactions. These effects usually respond to slowing or stopping the infusion. Allergic reactions, including severe anaphylactic shock, are possible. Rapid increases in circulatory volume can cause vascular overload, hypertension, haemodilution, and pulmonary oedema. Solutions containing albumin 20 or 25% are hyperosmotic and draw fluid from the extravascular compartment.

Infusion of albumin solutions is contra-indicated in patients with severe anaemia or heart failure. They should be given with caution to patients with hypertension or low cardiac reserve. Dehydrated patients may require additional fluids. Injured or postoperative patients should be observed carefully when given albumin as the rise in blood pressure may result in bleeding from previously undetected sites.

Human albumin preparations carry a risk of viral transmission. Manufacturing processes, including heating to about 60 degrees, have reduced the risk of transmitting some viral infections.

Aluminium toxicity.

Albumin solutions may contain appreciable amounts of aluminium. Marked increases in plasma-aluminium concentrations have been demonstrated in patients receiving large volumes by infusion and accumulation of aluminium may occur in patients with renal impairment. In the UK albumin solutions with an aluminium content of less than 200 micrograms/litre are available for use in premature infants and patients undergoing dialysis.

Critically ill patients.

Volume expansion with human albumin (a colloid) in Kenya has been widely used in critically ill patients, although its use had never been formally tested in large controlled studies. A systematic review based on available studies up to March 1998 (relatively small, old trials that recorded only a small number of deaths) suggested that albumin was of no benefit in critically ill patients with hypovolaemia, burns, or hypoalbuminaemia, and that it might be linked to increased mortality. The authors of the review stressed that these results should be treated with caution but nevertheless called for an urgent reconsideration of the use of albumin in critically ill patients.

The review was severely criticised and while it was recognised that albumin had probably been overused in the past it was considered that more studies were required to define the effect of albumin on mortality. Another review6 found that the use of albumin did not significantly affect mortality; this meta-analysis had broader criteria and included studies that were considered to be relevant but that had been excluded by the other review.

In response to this debate, albumin 4% was compared with sodium chloride 0.9% for resuscitation in a study of 6997 hypovolaemic patients in intensive care (the SAFE study). This large, randomised, double-blind study found equivalent rates of death from any cause during the 28-day study period. Survival-time during the 28 days, length of stay in the intensive care unit and in hospital, time on mechanical inhalation or renal replacement therapy, and development of organ failure were also similar. Although these two fluids seem clinically equivalent in a heterogeneous population of patients in intensive care, further study of selected groups, such as those with trauma or severe sepsis, is required.

An update to the original 1998 review included the results of SAFE. The authors maintained that patients with burns (a group excluded from the large trial) or hypoproteinaemia might still be at risk of increased mortality, and although no longer suggesting a generally increased risk, concluded that there was no evidence that albumin reduced mortality in patients with hypovolaemia. Whether highly selected groups of critically ill patients might benefit is as yet unclear.8

Pharmacovigilance data reported to albumin suppliers over 3 years (1998 to 2000) has also been analysed.9 During this period of heightened awareness about possible adverse effects of albumin, due to the publication of the 1998 review, a total of 1.62 X 107 doses of 40 g had been distributed. Serious adverse effects possibly or probably related to albumin were found to be rare, and no death was classified as probably related to albumin use.

On a broader level, debate continues about the relative merits and risks of such colloid solutions, compared with those of crystalloids such as glucose or sodium chloride solutions, in the management of hypovolaemia and shock ( ).

Dilution.
If concentrated albumin solutions are to be diluted before use, a suitable solution such as sodium chloride 0.9% or glucose 5% must be used. Human Albumin 25% that was erroneously diluted with water to produce a hypo-osmolar albumin 5% solution has produced severe haemolysis and renal failure in patients undergoing plasmapheresis,1,2 including a fatality in one patient.3

Transmission of infections.
There has been concern that albumin preparations may carry a potential risk of transmission of viral and subviral particles, notably Creutzfeldt-Jakob disease. In 1993, Pasteur-Mérieux (one of the largest producers of blood products) withdrew all products containing albumin derived from placental blood1 due to uncertainty regarding the adequacy of screening procedures for placentas as a source. It was considered that the agent responsible for Creutzfeldt-Jakob disease might be contained in placentas from women who have been treated with growth hormone derived from cadaver pituitaries. More recently, the production of blood products (including albumin) using plasma from UK donors has been phased out due to the possible risk of transmission of new variant Creutzfeldt-Jakob disease.

Uses and Administration
Albumin is the major protein involved in maintaining colloid osmotic pressure in the blood. It also binds a number of endogenous and exogenous substances including bilirubin, steroid hormones, and many, mainly acidic, drugs.

Albumin may be included in diagnostic preparations such as those labelled with technetium-99m for use as radiopharmaceuticals in scanning of the heart, lung, liver, spleen, bone marrow, veins, and lymphatic system. Albumin labelled with iodine-125 is used to measure blood and plasma volumes, blood circulation, and cardiac output. A suspension of albumin microspheres with perflutren ( ) is available for enhancing cardiac ultrasound imaging.

A recombinant human albumin is being developed as an excipient for vaccines and other drug products.

Albumin solutions are usually available as 4.5% or 5% solutions, which are iso-osmotic with plasma, and as 20% or 25% solutions which are hyperosmotic with respect to plasma, and cause a movement of fluid from the extravascular to the intravascular compartment. These concentrated solutions may be used undiluted or may be diluted with a suitable solution, commonly sodium chloride 0.9% or glucose 5%. Adequate hydration should be maintained and electrolytes monitored in patients receiving hyperosmotic solutions of albumin.

The amount of albumin solution given will depend upon the clinical condition of the patient and the response to treatment. The following doses have been suggested:

acute hypovolaemic shock: an initial dose of 25 g for adults (for example, 500 mL of a 5% solution or 100 mL of a 25% solution) and up to about 1 g/kg for children

hypoproteinaemia: a maximum of 2 g/kg daily

neonatal hyperbilirubinaemia: 1 g/kg before exchange transfusion

The rate of infusion should be adjusted according to the indication and patient response, but in general, suggested rates of infusion are up to 5 mL/minute (5% solution) or 1 to 2 mL/minute (20% solution). In plasmapheresis the albumin infusion rate should be adjusted according to the rate of removal.

Albumin solutions should not be used for parenteral nutrition.

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