Rho(D) Immune Globulin (Human) -- BayRho-D® Full Dose treated with solvent/detergent is a sterile solution of immune globulin containing antibodies to Rho(D) for intramuscular administration; it contains no preservative.
BayRho-D Full Dose is indicated for the following:
PREGNANCY AND OTHER OBSTETRIC CONDITIONS
BayRho-D Full Dose is recommended for the prevention of Rh hemolytic disease of the newborn by its administration to the Rho(D) negative mother within 72 hours after birth of an Rho(D) positive infant,12 providing the following criteria are met:
The mother must be Rho(D) negative and must not already be sensitized to the Rho(D) factor.
Her child must be Rho(D) positive, and should have a negative direct antiglobulin test (see PRECAUTIONS).
If BayRho-D Full Dose is administered antepartum, it is essential that the mother receive another dose of BayRho-D Full Dose after delivery of an Rho(D) positive infant.
If the father can be determined to be Rho(D) negative, BayRho-D Full Dose need not be given.
BayRho-D Full Dose should be administered within 72 hours to all nonimmunized Rho(D) negative women who have undergone spontaneous or induced abortion, following ruptured tubal pregnancy, amniocentesis or abdominal trauma unless the blood group of the fetus or the father is known to be Rho(D) negative.7,8 If the fetal blood group cannot be determined, one must assume that it is Rho(D) positive,2 and BayRho-D Full Dose should be administered to the mother.
BayRho-D Full Dose may be used to prevent isoimmunization in Rho(D) negative individuals who have been transfused with Rho(D) positive red blood cells or blood components containing red blood cells. 5,13