HYPERRHO S/D FULL DOSE Solution for injection Ref.[11135] Active ingredients: Anti-D (rh) immunoglobulin

HyperRHO S/D Full Dose is used to prevent isoimmunization in the Rh_o(D) negative individual exposed to Rh_o(D) positive blood as a result of a fetomaternal hemorrhage occurring during a delivery of an Rh_o(D) positive infant, abortion (either spontaneous or induced), or following amniocentesis or abdominal trauma. Similarly, immunization resulting in the production of anti-Rh_o(D) following transfusion of Rh positive red cells to an Rh_o(D) negative recipient may be prevented by administering Rh_o(D) Immune Globulin (Human).(5,6)

Rh hemolytic disease of the newborn is the result of the active immunization of an Rh_o(D) negative mother by Rh_o(D) positive red cells entering the maternal circulation during a previous delivery, abortion, amniocentesis, abdominal trauma, or as a result of red cell transfusion.(7,8) HyperRHO S/D Full Dose acts by suppressing the immune response of Rh_o(D) negative individuals to Rh_o(D) positive red blood cells. The mechanism of action of HyperRHO S/D Full Dose is not fully understood.

The administration of Rh_o(D) Immune Globulin (Human) within 72 hours of a full-term delivery of an Rh_o(D) positive infant by an Rh_o(D) negative mother reduces the incidence of Rh isoimmunization from 12%–13% to 1%–2%.(9)

The 1%–2% treatment failures are probably due to isoimmunization occurring during the latter part of pregnancy or following delivery.(10) Bowman and Pollock(11) have reported that the incidence of isoimmunization can be further reduced from approximately 1.6% to less than 0.1% by administering Rh_o(D) Immune Globulin (Human) in two doses, one antenatal at 28 weeks' gestation and another following delivery.

In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.