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

HyperRHO S/D Full Dose is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Therapeutics LLC [1-800-520-2807].

The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.

NEVER ADMINISTER HYPERRHO S/D FULL DOSE INTRAVENOUSLY. INJECT ONLY INTRAMUSCULARLY. NEVER ADMINISTER TO THE NEONATE.

Rh_o(D) Immune Globulin (Human) should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

The attending physician who wishes to administer Rh_o(D) Immune Globulin (Human) to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.

Reactions to Rh_o(D) Immune Globulin (Human) are infrequent in Rh_o(D) negative individuals and consist primarily of slight soreness at the site of injection and slight temperature elevation. While sensitization to repeated injections of human immune globulin is extremely rare, it has occurred. Elevated bilirubin levels have been reported in some individuals receiving multiple doses of Rh_o(D) Immune Globulin (Human) following mismatched transfusions. This is believed to be due to a relatively rapid rate of foreign red cell destruction.

A large fetomaternal hemorrhage late in pregnancy or following delivery may cause a weak mixed field positive D^u test result. If there is any doubt about the mother’s Rh type, she should be given Rh_o(D) Immune Globulin (Human). A screening test to detect fetal red blood cells may be helpful in such cases.

If more than 15 mL of D-positive fetal red blood cells are present in the mother’s circulation, more than a single dose of HyperRHO S/D Full Dose is required. Failure to recognize this may result in the administration of an inadequate dose.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.

Other antibodies in the Rh_o(D) Immune Globulin (Human) preparation may interfere with the response to live vaccines such as measles, mumps, polio or rubella. Therefore, immunization with live vaccines should not be given within 3 months after Rh_o(D) Immune Globulin (Human) administration.

Animal reproduction studies have not been conducted with Rh_o(D) Immune Globulin (Human) — HyperRHO S/D Full Dose. It is also not known whether HyperRHO S/D Full Dose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperRHO S/D Full Dose should be given to a pregnant woman only if clearly needed.

Safety and effectiveness in the pediatric population have not been established.

Babies born of women given Rh_o(D) Immune Globulin (Human) antepartum may have a weakly positive direct antiglobulin test at birth.

Passively acquired anti-Rh_o(D) may be detected in maternal serum if antibody screening tests are performed subsequent to antepartum or postpartum administration of Rh_o(D) Immune Globulin (Human).