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LAVIV TM . (azficel-T)Suspension for Intradermal Injection
2015-12-10 03:08:57 来源: 作者: 【 】 浏览:409次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LAVIVTM (azficel-T) safely and effectively. See full prescribing information for LAVIV TM .
    LAVIV
    TM . (azficel-T)
    Suspension for Intradermal Injection.
    Initial U.S. Approval: 2011
     

    INDICATIONS AND USAGE

    LAVIVTM (azficel-T) is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. (1)


    The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. (1)


    The efficacy of LAVIV beyond six months has not been established. (1)

    DOSAGE AND ADMINISTRATION

    For autologous intradermal injection only

    Only healthcare providers who have completed a Fibrocell-approved training program should administer LAVIV. (2)


    Inject LAVIV at 0.1 milliliter per linear centimeter into the nasolabial fold wrinkles. The recommended treatment regimen is three treatment sessions at 3-6 week intervals. (2)

    DOSAGE FORMS AND STRENGTHS

    A single vial of LAVIV contains approximately 18 million autologous fibroblasts in a 1.2 milliliters suspension, sufficient to administer 1 milliliter of product. (3)

    CONTRAINDICATIONS

    • Allogeneic use of LAVIV
    • Allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO), or material of bovine origin
    • Active infection in the facial area

    WARNINGS AND PRECAUTIONS

    • Hypersensitivity reactions can occur with LAVIV. (5.1)
    • LAVIV can cause bleeding and bruising at the treatment site. (5.2)
    • Vasculitis has occurred following treatment with LAVIV. (5.3)
    • Herpes labialis has occurred following treatment with LAVIV. (5.4)
    • Basal cell cancer has occurred following treatment with LAVIV. (5.5)
    • Keloid and hypertrophic scarring may occur following post-auricular skin biopsies or LAVIV injections. (5.6)
    • Patients with genetic disorders affecting dermal fibroblasts or formation of normal collagen matrices may have an abnormal response to LAVIV. (5.7)
    • Immunosuppressed patients, or those who undergo chemotherapy for malignancies or receive immunomodulatory therapies for autoimmune diseases, may have an increased susceptibility to infection and difficulty healing from LAVIV treatments. (5.8)
    • Employ universal precautions when handling LAVIV. Patients undergoing procedures associated with LAVIV are not routinely tested for adventitious viruses. (5.9)
    • Sterility tests are not completed when LAVIV is shipped to the clinic. (5.10)
    ADVERSE
    以下是“全球医药”详细资料
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