Alburel

Alburel

human albumin

Manufacturer:

Reliance

Distributor:

Ambica

Marketer:

Ambica
Full Prescribing Info
Contents
Human albumin.
Description
Each mL contains: Concentration available (%) 20%, Pack size 50 mL/100 mL, Total Protein 0.2 g (200 mg), Sodium Caprylate 0.00665 mg, Na+ not more than 160 μM, K+ not more than 2 μM, Aluminium ≤ 0.0002 mg.
Human albumin does not contain any antimicrobial agents.
Action
Pharmacology: Albumin is a highly soluble, globular protein (molecular weight 66, 500), accounting for 70-80% of the colloid osmotic pressure of plasma. Therefore, albumin is important in regulating the osmotic pressure of plasma. Albumin 20% solution will increase the circulating plasma volume by four times the volume infused. This extra fluid reduces haemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume. When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The haemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume. Albumin also functions as a transport protein and binds to naturally occurring, therapeutic and toxic materials in the circulation. The binding properties of albumin may, in special circumstances, provide an indication for its clinical use.
Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 Kg man is approximately 320 g; it has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.
Indications/Uses
Clinical Indications: Albumin (Human Albumin), may be given intravenously without dilution or it may be diluted with normal saline or 5% glucose before administration. The addition of one volume of albumin solution to four volumes of normal saline or 5% glucose gives a solution approximately isotonic and iso-osmotic with citrated plasma. When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough (1 mL per minute) to prevent too rapid expansion of plasma volume.
Hypovolemic shock: Albumin is indicated in the treatment of hypovolemic 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: Albumin is used for severe burns (>15% body surface area) after the first 24 hours, if hypoproteinaemia develops and/or to maintain plasma volume.
Hypoproteinemia: Albumin is indicated in the treatment of hypo-proteinaemia caused by a loss of plasma proteins. Loss of plasma proteins may occur through decreased absorption in gastrointestinal disorders, inadequate synthesis in chronic liver diseases or excessive urinary catabolism in chronic liver diseases. 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: Albumin may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid in patients suffering from ascites.
Plasma exchange/dialysis: Albumin 20% may be used as an adjunct in patients who are undergoing long-term haemodialysis and are susceptible to shock and hypotension, or in dialysis patients who are hypovolaemic and may not tolerate large volumes of crystalloid infusion as treatment for shock or hypotension.
Indications: 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 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 hypovolemic shock. They are also used as an exchange fluid in therapeutic plasmapheresis. Concentrated albumin solutions are used in neonatal hyperbilirubinaemia.
Dosage/Direction for Use
The amount of albumin solution given will depend upon the clinical condition of the patient and the response to treatment.
Acute Hypovolemic shock: An initial dose of 25 g for adults 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 infusions are up to 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.
Overdosage
Rapid infusion and large volumes may cause hypervolemia. The physician is recommended to look for clinical signs and symptoms and stop infusion immediately.
Contraindications
Albumin is contraindicated in patients with severe anaemia or cardiac failure in the presence of normal or increased intravascular volume.
The use of Albumin is contraindicated in patients with a history of allergic reactions to Albumin preparations.
Special Precautions
General: Solutions of Albumin should not be used if they appear turbid or if there is sediment in the bottle. Contents must not be used more than four hours after the container has been penetrated. Discard unused portion.
Medical products prepared from human plasma carry a very remote risk of transmission of infective agents that are reduced by several methodologies.
Albumin 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.
Patients with marked dehydration require administration of additional fluids. Albumin may be administered with the usual dextrose and saline intravenous solutions. However, solutions containing protein hydrolysates or alcohol must never be infused through the same administration set in conjunction with Human Albumin since these combinations may cause precipitation of proteins.
Use in Pregnancy: Pregnancy Category C: There are no known adverse reports on Albumin usage in pregnant women in any trimester or to the foetus.
Use in Children: Appropriate dose based on body weight is not known to cause any undesirable effect.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Category C: There are no known adverse reports on Albumin usage in pregnant women in any trimester or to the foetus.
Side Effects
Allergic or pyrogenic reactions are characterized primarily by fever and chills. Rash, nausea, vomiting, tachycardia, hypotension and increased salivation have also been reported. Should an adverse reaction occur, stop the infusion immediately for a period of time, which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Albumin, material from a different lot should be used.
Albumin, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.
Caution For Usage
Human Albumin is available in 20% concentration. Physicians are requested to refer to the contents chart for each formulation.
Product Safety: The manufacturing process for Human Albumin uses plasma collected from approved blood banks where the donors are screened for their history as per guidelines laid down by the regulatory authorities. Their blood is screened for the mandatory infectious diseases. These are repeat donors whose samples are quarantined and retested. Only on being declared negative to HbsAg, HIV I & II antibodies and HCV RNA the plasma is used for processing. The manufacturing procedure incorporates Heat Pasteurization (60°C for 10 hours), which inactivates viruses. After manufacturing, the product is tested by suitable methods to show freedom from viruses like HIV, HBV, HCV, Parvovirus and HAV. Multiple steps have been employed to assure product safety hence there is a very remote probability that unknown infectious agents may be present in these products like newer emerging viruses and theoretical CJD (Creutzfeldt Jakob disease). The process parameters, characterizations and final product quality are designed such, that they meet the regulatory requirements. Records of blood donors whose plasma have been used for manufacturing of this product has been maintained for at least ten years at the site of origin.
Storage
Store the container at or below 25°C. Do not freeze. Protect from light.
Shelf Life: 3 years from the date of manufacturing.
ATC Classification
B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.
Presentation/Packing
Inj 20% x 50 mL, 100 mL.
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