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  • Gliadel Wafer
    / Megapharm


    Active Ingredient *
    Polideprosan 192.3 mg
    Carmustine 7.7 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Wafer

    8

    not in the basket chart 69961 7872

    Dosage

    Each Wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight wafers are implanted. It is recommended that eight wafers be placed in the resection cavity if the size and shape of it allows. Should the size and shape not accommodate eight wafers, the maximum number of wafers as allowed should be placed.
    Since there is no clinical experience, no more than eight wafers should be used per surgical procedure.


    Indications

    For use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated.
    Gliadel implant is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation.
    Gliadel implant is indicated for use as an adjunct to surgery in patients with Recurrent histogically proved glioblastoma multiforme for whom surgical resection is indicated.


    Contra-Indications

    GLIADEL Wafer contains carmustine. GLIADEL Wafer should not be given to
    individuals who have demonstrated a previous hypersensitivity to carmustine or any of the components of GLIADEL Wafer.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    Interactions with other drugs have not been formally evaluated.


    Pregnancy and Lactation

    Pregnancy: There are no studies assessing the reproductive toxicity of GLIADEL Wafer. Carmustine, the active component of GLIADEL Wafer, can cause fetal harm when administered to a pregnant woman.
    If GLIADEL Wafer is used during pregnancy, or if the patient becomes pregnant after GLIADEL Wafer implantation, the patient must be warned of the potential hazard to the fetus.
    Nursing Mothers: It is not known if either carmustine, carboxyphenoxypropane, or sebacic acid is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from carmustine in nursing infants, it is recommended that patients receiving GLIADEL Wafer discontinue nursing.


    Overdose

    There is no clinical experience with use of more than eight GLIADEL Wafers per surgical procedure.


    Important notes

    Storage: GLIADEL Wafer must be stored at or below -20ºC (-4ºF).


    Manufacturer
    Eisai Inc.
    Licence holder
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