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  • Carboplatin Ebewe
    / Novartis


    Active Ingredient
    Carboplatin 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    150 mg / 15 ml

    partial basket chart 28850 3806

    Vial

    450 mg / 45 ml

    partial basket chart 28851 3807

    Related information


    Dosage

    Previously untreated adult patients with normal renal function receive 400 mg carboplatin/m² body surface as IV short-term infusion (15-60 min), therapy cycles can be repeated after 4 weeks therapy-free interval. Patients with risks (previously treated with myelosuppressive drugs and/or radiation therapy, or general poor condition) should be treated with an initial dose of 300-320 mg/m². In patients with impaired renal function the carboplatin dose must be reduced and adapted to the glomerular filtration rate.
    A suggested dosage schedule based on creatinine clearance is as follows:
    Creatinine Clearance (ml/min): ≥40 ml per minute; Dosage of Carboplatin: 400 mg/m².
    Creatinine Clearance (ml/min): 20-39 ml per minute; Dosage of Carboplatin: 250 mg/m².
    Creatinine Clearance (ml/min): 0-19 ml per minute; Dosage of Carboplatin: 150 mg/m².
    For children no specific dosage recommendations can be made because of lack of experience in this field.
    Route of administration: Carboplatin is administered after preparation of the solution as IV short-time infusion over a period of 15-60 min.
    Dilution: The product may be diluted with 5% Glucose for Injection BP to concentrations as low as 0.4 mg/ml (400 microgram/ml).
    Since the formulation does not contain antibacterial preservatives, it is recommended that any carboplatin solution should be discarded after eight hours from dilution if stored at room temperature or after 24 hours if stored refrigerated.


    Indications

    Carboplatin is used alone or in combination with other antineoplastic agents in the treatment of advanced ovarian carcinoma and metastatic small-cell lung cancer.


    Contra-Indications

    – Hypersensitivity to drug components or other platinum-containing agents;
    – Patients with bleeding tumours;
    – Pregnancy and lactation period;
    – Severe myelosuppression;
    – Renal impairment (glomerular filtration rate <30 ml/min);
    – Hearing impairment.


    Special Precautions

    To be administered after preparation of the solution as I.V. short-time infusion over a period of 15-60 minutes. Solution should be discarded after eight hours from dilution if stored at room temperature or after 24 hours if stored refrigerated. Should be administered under the direction of an oncologist. Carboplatin myelosuppression is closely related to its renal clearance.
    Patients with abnormal kidney function or receiving concomitant therapy with other potentially nephrotoxic drugs. Renal function parameters should be carefully assessed before and during therapy.
    Should not be repeated more frequently than monthly under normal circumstances.
    Weekly monitoring of peripheral blood counts is recommended during the initial course of therapy.
    Combination therapy with other myelosuppressive compounds must be planned very carefully with respect to dosages and timing. Neurological evaluations should be performed regularly.
    Cases of hepatic toxicity associated with renal toxicity have been reported with very high doses.
    May impair concentration and ability in driving and operating machinery.
    Should not be used during pregnancy and lactation.


    Side Effects

    Myelosuppression, thrombocytopenia, leucopenia and anemia. Increased blood urea or serum creatinine levels can occur. Renal function impairment. Decreased serum electrolytes. Hyponatremia. Nausea, vomiting, infrequent allergic reactions. Subclinical decrease in hearing acuity. Incidence of peripheral neuropathies after treatment is 4%. Transient visual disturbances, abnormalities in liver function tests.
    See prescribing information for full details.


    Drug interactions

    Other myelosuppressive compounds. Aminoglycocides or other agents with similar toxicity.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: The safe use of carboplatin during pregnancy has not been established. Animal studies have shown carboplatin to be embryotoxic and teratogenic in rats and it should not be used during pregnancy.
    Carboplatin has been shown to be mutagenic in vivo and in vitro. The carcinogenic potential of carboplatin has not been studied, but compounds with similar mechanisms of action and mutagenicity have been reported to be carcinogenic.
    Nursing mothers: It is not known whether carboplatin is excreted in human milk. Therefore, it should not be administered to women who are breastfeeding infants.


    Overdose

    A specific antidote for overdosage is not available.
    There is no known antidote for carboplatin overdosage. The anticipated complications of overdosage would be related to myelosuppression as well as impairment of hepatic and renal functions.


    Manufacturer
    Ebewe Pharma
    Licence holder
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