Alburel

Alburel Caution For Usage

human albumin

Manufacturer:

Reliance

Distributor:

Ambica

Marketer:

Ambica
Full Prescribing Info
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.
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