Rhophylac

Product Specs	Description
Manufacturer Name	CSL Behring
Indications	Rhophylac is an Rh0(D) Immune Globulin Intravenous (Human) indicated for: Suppression of Rhesus (Rh) Isoimmunization in: Pregnancy and obstetric conditions in non-sensitized, Rh0(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 Rh0(D)-negative individuals transfused with blood components containing Rh0(D)-positive red blood cells (RBCs) Immune Thrombocytopenic Purpura (ITP): Raising platelet counts in Rh0(D)-positive, non-splenectomized adults with chronic ITP
Contraindications	History of anaphylactic or severe systemic reaction to human immune globulin products. IgA deficient patients with antibodies against IgA and a history of hypersensitivity to RHOPHYLAC or any of its components. Do not administer to the newborn infant of the mother that received RHOPHYLAC postpartum.
Viral Safety Process	Solvent/detergent and nanofiltration (Planova 15 nm): Effective for inactivating and removing enveloped and non-enveloped viruses.
Route of Administration	IV or IM depending on indication
Clearance of Rh-positive Red Blood Cells	Both the IV and IM administration of a 1500 IU (300 mcg) dose 24 hours after injection of 15 mL of Rh(D)-positive RBCs resulted in an effective clearance of Rh(D)-positive RBCs.
Product Half-Life	16 ± 4 days for IV administration, 18 ± 5 days for IM administration
Latex Content	No
Thimerosal Content	No
Storage Requirements/Shelf Life	Refrigerate at 2°C to 8°C (36°F to 46°F) for up to 36 months from manufacture date. Do not freeze. Keep in original carton to protect it from light.
Supply Method	Prefilled, ready-to-use, glass syringe(s). Each syringe is accompanied by SafetyGlide needle.
Available Sizes	One or ten (10) single-dose prefilled syringes each containing 2 mL liquid for injection.