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1 Indications And Usage Winrho ® Sdf Is A 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 A 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 A 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, Transplacental Hemorrhage Resulting From Antepartum Hemorrhage) – Invasive Procedures During Pregnancy (E.g., Amniocentesis, Chorionic Biopsy) Or Obstetric Manipulative Procedures (E.g., External Version, Abdominal Trauma) A 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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