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    WINRHO SDF LIQUID

    RHO (D) IMMUNE GLOBULIN I.V. HUMAN

    BOXED WARNING: ACUTE RENAL DYSFUNCTION and FAILURE; RISK OF THROMBOSIS
    See full prescribing information for complete boxed warning.
    • Renal dysfunction, acute renal failure, osmotic nephrosis, and death may be associated with Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients.
    • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. GAMUNEX does not contain sucrose.
    • Administer IGIV products at the minimum concentration available and the minimum infusion rate practicable.
    • FDA has analyzed recent data that has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. Additional caution regarding the use of these products is warranted.
    • FDA is requiring manufacturers to add information on thrombosis to the current boxed warning in the labels of all intravenous human immune globulin products and to add a boxed warning to the labels of all subcutaneous and intramuscular human immune globulin products to highlight the risk of thrombosis and to add information on its mitigation.

    HOW MEDICINE IS ADMINISTERED? TOP
    Use this medicine exactly as directed on the label, unless instructed differently by your doctor
    * This medication is usually given by injection and administered by a healthcare professional.
    * Follow manufacturer's directions to properly reconstitute.
    WARNINGS/PRECAUTIONS: TOP
    * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR.
    Other Common Side Effects: TOP
    Low blood pressure; High blood pressure; Back pain; Fever; Injection site reaction; Nausea; Serum creatinine elevation; Vomiting.
    Other Common Side Effects:
    If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients.



    Copyright © CliniDATA Source, Inc. 03/14. All rights reserved


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