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1 Indications And Usage Winrho ® Sdf Is An Rh O (D) Immune Globulin Intravenous (Human) (Anti-D) Product That Is Indicated For The Treatment Of Itp In Rh O (D)-Positive Patients And For The Suppression Of Rh Isoimmunization In Non-Sensitized Rh O (D)-Negative Patients. Winrho ® Sdf Is A Rh O (D) Immune Globulin Intravenous (Human) Indicated For: Immune Thrombocytopenic Purpura (Itp) (1.1) Raising Platelet Counts In Rh O (D) Positive, Non-Splenectomized: Children With Chronic Or Acute Itp Adults With Chronic Itp Children And Adults With Itp Secondary To Hiv Infection Suppression Of Rhesus (Rh) Isoimmunization (1.2) Pregnancy And Other Obstetric Conditions In Non-Sensitized, Rh O (D)-Negative Women With An Rh-Incompatible Pregnancy Including: Routine Antepartum And Postpartum Rh Prophylaxis Rh Prophylaxis In Obstetric Complications Or Invasive Procedures Incompatible Transfusions In Rh O (D)-Negative Individuals Transfused With Blood Components Containing Rh O (D)-Positive Red Blood Cells (Rbcs). 1.1 Treatment Of Itp Winrho Sdf Is Indicated For Use In Clinical Situations Requiring An Increase In Platelet Count To Prevent Excessive Hemorrhage In The Treatment Of Non-Splenectomized, Rh O (D)-Positive Children With Chronic Or Acute Itp Adults With Chronic Itp Children And Adults With Itp Secondary To Hiv Infection The Safety And Efficacy Of Winrho Sdf Have Not Been Evaluated In Clinical Trials For Patients With Non-Itp Causes Of Thrombocytopenia Or In Previously Splenectomized Patients Or In Patients Who Are Rh O (D)-Negative. 1.2 Suppression Of Rh Isoimmunization Pregnancy And Other Obstetric Conditions Winrho Sdf Is Indicated For The Suppression Of Rh Isoimmunization In Non-Sensitized, Rh O (D)-Negative (D-Negative) Women With An Rh-Incompatible Pregnancy, Including: Routine Antepartum And Postpartum Rh Prophylaxis Rh Prophylaxis In Cases Of: – Obstetric Complication (E.g., Miscarriage, Abortion, Threatened Abortion, Ectopic Pregnancy Or Hydatidiform Mole, Transplancental Hemorrhage Resulting From Antepartum Hemorrhage) – Invasive Procedures During Pregnancy (E.g., Amniocentesis, Chorionic Biopsy) Or Obstetric Manipulative Procedures (E.g., External Version, Abdominal Trauma) An Rh-Incompatible Pregnancy Is Assumed If The Fetus/baby Is Either Rh O (D)-Positive Or Rh O (D)-Unknown Or If The Father Is Either Rh O (D)-Positive Or Rh O (D)-Unknown. Incompatible Transfusions Winrho Sdf Is Indicated For The Suppression Of Rh Isoimmunization In Rh O (D)-Negative Individuals Transfused With Rh O (D)-Positive Red Blood Cells (Rbcs) Or Blood Components Containing Rh O (D)-Positive Rbcs. Winrho Sdf Is Not Indicated For Use As Immunoglobulin Replacement Therapy For Immune Globulin Deficiency Syndromes.
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