Anthrasil - Anthrax Immune Globulin Injection
ANTHRASIL is a clear to opalescent sterile liquid of purified immune globulin G (IgG) fraction of human plasma containing polyclonal antibodies that bind the protective antigen (PA) component of Bacillus anthracislethal and edema toxins.ANTHRASIL is prepared using plasma collected from healthy, screened donors who were immunized with BioThrax®(Anthrax Vaccine Adsorbed) to achieve high titers of anti-anthrax antibody (meeting minimum potency specifications) and purified by an anion-exchange column chromatography method.Product potency, as determined by the Toxin Neutralization Assay, is expressed in units (U) by comparison to the Centers for Disease Control and Prevention (CDC) standard AVR414.A single use 50 mL vial contains anti-anthrax antibodies at ≥60 Units by Toxin Neutralization Activity (TNA), regardless of fill volume.
Features
- Acute renal dysfunction, acute renal failure, acute kidney injury, osmotic nephropathy, acute tubular necrosis, proximal tubular nephropathy, and death may occur in patients receiving immune globulin treatment, including ANTHRASIL. Increases in serum creatinine and blood urea nitrogen have been observed as soon as one to two days after treatment with other IGIVs.
- Risk factors include, but are not limited to, those with any degree of pre-existing renal insufficiency and in patients at risk of developing renal insufficiency including those with diabetes mellitus, age greater than 65 years, volume depletion, paraproteinemia, sepsis and patients receiving known nephrotoxic drugs.
- Ensure that patients are not volume depleted before administering ANTHRASIL. Administer ANTHRASIL at the minimum concentration available and at the minimum infusion rate practicable. Do not exceed the recommended infusion rate. If renal function deteriorates, consider discontinuing ANTHRASIL.
- Periodic monitoring of renal function and urine output is important in patients judged to be at increased risk of developing acute renal failure. Assess renal function before the initial infusion of ANTHRASIL and at appropriate intervals thereafter.
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