Rhophylac



RHOPHYLAC®

Product Specs RHOPHYLAC®
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
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    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.
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    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.
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    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.


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