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  • Dacarbazine Medac
    / Tzamal


    Active Ingredient
    Dacarbazine (as Citrate) 200, 500, 1000 mg/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 200 mg/vial

    partial basket chart 86830 4523

    Vial

    1 X 500 mg/vial

    partial basket chart 86831 4524

    Vial

    1 X 1000 mg/vial

    partial basket chart 86832 4525

    Related information


    Dosage

    Malignant Melanoma: Dacarbazine can be administered as single agent in doses of 200 to 250 mg/m² body surface area/day as an i.v. injection for 5 days every 3 weeks. As an alternative to an intravenous bolus injection dacarbazine can be administered as a shortterm infusion (over 15 – 30 minutes).
    It is also possible to give 850 mg/m² body surface area on day 1 and then once every 3 weeks as intravenous infusion.
    Hodgkin’s Disease: Dacarbazine is administered in a daily dose of 375 mg/m² body surface area i.v. every 15 days in combination with doxorubicin, bleomycin and vinblastine (ABVD regimen). During dacarbazine treatment frequent monitoring of blood counts should be conducted as well as monitoring of hepatic and renal function. Since severe gastrointestinal reactions frequently occur, antiemetic and supportive measures are advisable.
    Because severe gastrointestinal and hematological disturbances can occur an extremely careful benefit-risk analysis has to be made before every course of therapy with dacarbazine.
    Duration of therapy: The treating physician should individually decide about the duration of therapy taking into account the type and stage of the underlying disease, the combination therapy administered and the response to and adverse effects of dacarbazine. In advanced Hodgkin’s disease, a usual
    recommendation is to administer 6 cycles of ABVD combination therapy. In metastasized malignant melanoma and in advanced tissue sarcoma, the duration of treatment depends on the efficacy and tolerability in the individual patient.
    Rate of administration: Doses up to 200 mg/m2 may be given as a slow intravenous injection. Larger doses (ranging from 200 to 850 mg/m²) should be administered as an i.v. infusion over 15-30 minutes. It is recommended to test the patency of the vein first with a 5- to 10-ml flush of sodium chloride infusion solution or glucose 5%. The same solutions should be used after infusion to flush any remaining drug from the tubing. After reconstitution with water for injection without further dilution with sodium chloride infusion solution or glucose 5 %, dacarbazine 200 mg preparation is hypo-osmolar (ca. 100mOsmol/kg) and should therefore be given by slow intravenous injection e.g. over 1 minute rather than rapid intravenous bolus over a few seconds.
    Special populations:
    Patients with kidney/liver insufficiency: 
    If there is mild to moderate renal or hepatic insufficiency alone, a dose reduction is not usually required. In patients with combined renal and hepatic impairment elimination of dacarbazine is prolonged. However, no validated recommendations on dose reductions can be given currently.
    Elderly patients: As limited experience in elderly patients is available no special instructions for the use in elderly patients can be given.
    Children: No special recommendations for the use of dacarbazine in the paediatric age group can be given until further data become available.
    See prescribing information for full details.


    Indications

    Treatment of metastatic malignant melanoma. As a second line treatment: Part of a combination chemotherapy in advanced Hodgkin’s disease.


    Contra-Indications

    History of hypersensitivity reactions to dacarbazine, pregnancy and lactation, leucopenia and/or thrombocytopenia, severe liver or kidney diseases.


    Special Precautions

    See prescribing information for full details.


    Side Effects

    See prescribing information for full details.


    Drug interactions

    See prescribing information for full details.


    Manufacturer
    medac GmbH
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