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  • Anidulafungin Teva
    / Abic


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Powder for concentrate for solution for infusion, for I.V infusion after reconstitution and dilution

    100 mg

    VIAL

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    Dosage

    Treatment with Anidulafungin Teva should be initiated by a physician experienced in the management of invasive fungal infections.
    Specimens for fungal culture should be obtained prior to therapy. Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
    Posology
    A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter. Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.
    Duration of treatment
    There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
    Patients with renal and hepatic impairment
    No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. Anidulafungin Teva can be given without regard to the timing of haemodialysis.
    Other special populations
    No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly.
    Paediatric population
    The safety and efficacy of anidulafungin in children below 18 years have not been established. Anidulafungin Teva is not indicated for children and adolescents below 18 years of age.
    Method of administration
    For intravenous use only.
    Anidulafungin Teva should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL.  It is recommended that Anidulafungin Teva be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min. Anidulafungin Teva must not be administered as a bolus injection.
    Please refer to the license holder for further details.


    Indications

    Treatment of invasive candidiasis in adult patients.

     


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipient.
    Hypersensitivity to other medicinal products of the echinocandin class.

     


    Manufacturer
    Actavis, Italy S.P.S
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