Seroalbumin

Human albumin.

Each vial contains total protein 200 g/Lit, sodium caprylate 6.65 g/Lit, Na+ not more than 160 mmol/L, K+ not more than 2 mmol/L, aluminum <200 ug/L.
An aqueous solution of protein obtained from the plasma of healthy donors; the plasma is tested for the absence of hepatitis B surface antigen and antibodies against HIV-1 and HIV-2 and hepatitis C virus. It is prepared as a concentrated solution containing 15 to 25% of total protein or as an isotonic solution containing 3.5 to 5% of total protein; not less than 95% of the total protein is albumin. A suitable stabiliser, such as sodium octanoate or N-acetyltryptophan or a combination of the two, may be added but no antimicrobial preservative is added. It contains not more than 160 mmol of sodium per litre and not more than 200 micrograms of aluminium per litre. The solution is sterilized by filtration and distributed aseptically into containers which are sealed to prevent contamination and maintained at 59°C to 61°C for not less than 10 hours. Finally, the containers are incubated for not less than 14 days at 30°C to 32°C or for not less than 4 weeks at 20°C to 25° C and examined visually for signs of microbial contamination. It should be stored in a colourless glass container and protected from light. A clear, almost colourless, yellow, amber, or green slightly viscous liquid. A solution in sodium chloride 0.9% containing 1 % protein has a pH of 6. 7 to 7.3. The BP 2008 gives Albumin and Human Albumin as approved synonyms.

Pharmacology: Mechanism of Action: Blood volume expander: Albumin is an important regulator of the volume of circulating blood. It accounts for 70 to 80% of the colloid oncotic pressure of plasma. An infusion of albumin 5% is oncotically equivalent to an equal volume of human plasma and increases blood volume by an amount approximately equal to the volume of albumin infused; albumin 25% is oncotically equivalent to approximately 5 times the volume of human plasma and draws into the circulation an amount of fluid approximately 3.5 times the volume of albumin infused. Albumin provides a temporary increase in blood volume, which reduces hemoconcentration and blood viscosity.
Antihyperbilirubinemic: Albumin is a transport protein that reversibly binds both endogenous and exogenous substances including bilirubin, fatty acids, hormones, enzymes, drugs, dyes and trace metals.

Albumin replacement in patients with major albumin deficiency.

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient's individual requirements.
The choice of albumin rather than artificial colloid will depend on the clinical situation of the patient, based on official recommendations.
Posology: In general, dosage and infusion rate should be adjusted to the patient's individual requirements. When human albumin is used in replacement therapy, the dosage required is guided by the usual circulatory parameters.
The lowest limit for colloidal osmotic pressure is 20 mmHg (2.7 kPa).
If albumin is to be administered, the dose in grams required can be estimated using the following calculation: [required total proteins (g/L) - actual total proteins (g/L)] x plasma volume (L) x 2.
The physiological plasma volume may be calculated as approximately 40 mL/kg of body weight. In case of extensive substitution therapy and in cases with haematocrit below 30% (see Precautions).
Pediatric Use: The fact that in children the physiological plasma volume is age-dependent should be taken into account.
Method of Administration: Human Albumin is ready for use and is to be administered by intravenous infusion only.
The infusion rate should be adjusted according to individual circumstances and indications, normally be set at 1-2 mL/min.
Maximum time for administration is 3 hours. Infusion rate should not exceed 30 mL/min during plasmapheresis.
If large volumes are to be administered, the product should be warmed to room or body temperature before use.
When suggested by clinical indications, Human Albumin can be diluted with 0.9% NaCl solution and 5% or 10% glucose solutions.

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), increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion is to be stopped immediately and the patient's haemodynamic parameters carefully monitored. Additionally, diuresis and cardiac output should be increased according to the severity of the clinical situation.

Hypersensitivity to human albumin preparations or to any of the excipients. Allergic reactions to this preparation. All conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient. Examples of such conditions are: Decompensated cardiac insufficiency, Oesophageal varices, Pulmonary oedema, Haemorrhagic diathesis, Severe anaemia, Renal and post-renal anuria, Dehydration (unless sufficient fluid is infused simultaneously).

When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. This applies also to pathogens of hitherto unknown nature.
To reduce the risk of transmission of infective agents, donors and donations are duly screened.
Each unit of plasma used for the preparation of Human Albumin was tested and found negative for the presence of HBsAg, of HIV 1, HIV 2 and HCV antibodies, and was tested for the ALT content; the plasma pool has also been controlled for the presence of HCV-RNA through a genic amplification technique and the result was non reactive. The production process includes procedures for the removal and inactivation of viruses.
The ultrafiltration and diafiltration treatment removes metal ions; the risk of aluminum accumulation and of the toxicity related thereto are therefore drastically reduced.

If allergic reactions occur, the infusion should be stopped immediately. If allergic reactions persist, then appropriate treatment is recommended. In anaphylactic reactions, treatment should follow the current recommendations for shock therapy.
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.
If the required volume of Human Albumin 20% exceeds 200 mL, appropriate additional electrolyte solutions should be administered to maintain normal fluid balance.
Alternatively, therapy may be continued with 5% human albumin solution.
If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care should be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).
If haematocrit drops below 30%, packed red cells should be given in order to maintain the oxygen transport capacity of the blood.
Effects on the ability to drive and use machines: There are no indications that human albumin may impair the ability to drive or use machines.

The safety of human albumin for use in human pregnancy has not been determined by means of controlled clinical trials.
Experimental animal studies are insufficient to assess the safely with respect to reproduction, development of the embryo or foetus, course of gestation and peri and postnatal development.
However, human albumin is a normal constituent of human blood, therefore albumin may be used, if clearly needed, during pregnancy and lactation. However, in general, particular attention must be paid when a substitution of volume is affected in a pregnant patient.

No interactions of human albumin with other products are known so far.
Incompatibilities: Human Albumin should not be mixed with other drugs, whole blood or packed red cells, and with other solutions that may cause the precipitation of proteins.

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. 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.
Uses and Administration: Albumin is the major protein involved in maintaining colloid osmotic pressure in the blood. II also binds a number of endogenous and exogenous substances including bilirubin, steroid hormones, and many, mainly acidic, drugs. Albumin solutions 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. Concentrated albumin solutions are used in neonatal hyperbilirubinaemia associated with haemolytic disease of the newborn.
They have also been suggested 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. 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. Recombinant forms of human albumin have been developed as excipients for vaccines and other drug products, and for the treatment of hypoalbuminaemia and hypovolaemic shock. 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.

Store at temperatures not exceeding 25°C. Should be kept in a dark place.
Shelf Life: 36 months.

Intravenous & Other Sterile Solutions

B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.

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