Active Substance: Human anti-D immunoglobulin.
Overview
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This medicine contains an important and useful components, as it consists of
Human anti-D immunoglobulinis available in the market in concentration
Human Anti-D Immunoglobulin
IgA deficient patients with known antibodies to IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions . It is made from human blood; therefore it may contain infectious agents; e.g., viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent
Hemolytic disease of newborn, Rhesus disease
Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
The most serious adverse reactions in patients receiving Rh0(D) Immune Globulin Intravenous (Human) have been observed in the treatment of ITP and include intravascular hemolysis, clinically compromising anemia, acute renal insufficiency, and, very rarely, DIC and death The most common adverse reactions observed in the use for suppression of Rh isoimmunization (?0.5% of subjects) are nausea, dizziness, headache, injection-site pain, and malaise. The most common adverse reactions observed in the treatment of ITP (>14% of subjects) are chills, pyrexia/increased body temperature, and headache. Mild hemolysis (manifested by an increase in bilirubin, a decrease in hemoglobin, or a decrease in haptoglobin) was also observed.
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Anti-Rho(D) immune globulins from human donors.
May interfere with the immune response to live measles vaccine, live mumps vaccine, live rubella vaccine and live varicella vaccine, therefore these vaccines should be given at least 3 wk before or 3 mth after the admin of the immunoglobulins.
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