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EBETAXEL EBEWE

Package(a):
MULTIDOSE VIAL: 1 x 30 mg/5 ml.
Dosage(a):
135 mg/m², 175 mg/m² or 210 mg/m² administered IV over 24 hours, or over 3 hours respectively every 3 weeks as continuous infusion. Dosage is according to doctor’s instructions, and has to be adjusted according to the indication, general condition, cardiac or hepatic function and concurrent chemotherapy and the blood counts. See prescribing information for full details.
Prescribing Restrictions:   

Package(b):
MULTIDOSE VIAL: 1 x 100 mg/16.7 ml.
Dosage(b):
135 mg/m², 175 mg/m² or 210 mg/m² administered IV over 24 hours, or over 3 hours respectively every 3 weeks as continuous infusion. Dosage is according to doctor’s instructions, and has to be adjusted according to the indication, general condition, cardiac or hepatic function and concurrent chemotherapy and the blood counts. See prescribing information for full details.
Prescribing Restrictions:   

Package(c):
MULTIDOSE VIAL: 1 x 150 mg/25 ml.
Dosage(c):
135 mg/m², 175 mg/m² or 210 mg/m² administered IV over 24 hours, or over 3 hours respectively every 3 weeks as continuous infusion. Dosage is according to doctor’s instructions, and has to be adjusted according to the indication, general condition, cardiac or hepatic function and concurrent chemotherapy and the blood counts. See prescribing information for full details.
Prescribing Restrictions:    


Package(d):
MULTIDOSE VIAL: 1 x 300 mg/50 ml.
Dosage(d):
135 mg/m², 175 mg/m² or 210 mg/m² administered IV over 24 hours, or over 3 hours respectively every 3 weeks as continuous infusion. Dosage is according to doctor’s instructions, and has to be adjusted according to the indication, general condition, cardiac or hepatic function and concurrent chemotherapy and the blood counts. See prescribing information for full details.
Prescribing Restrictions:    


Package(e):
ONCOSAFE MULTIDOSE VIAL: 1 x 600 mg/100 ml.
Dosage(e):
135 mg/m², 175 mg/m² or 210 mg/m² administered IV over 24 hours, or over 3 hours respectively every 3 weeks as continuous infusion. Dosage is according to doctor’s instructions, and has to be adjusted according to the indication, general condition, cardiac or hepatic function and concurrent chemotherapy and the blood counts. See prescribing information for full details.
Prescribing Restrictions:    

Indications:
Alone or in combination, for the treatment of advanced carcinoma of the ovary. For the treatment of metastatic breast cancer after failure of combination chemotherapy. Prior therapy should have included an anthracycline unless clinically containdicated. For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. Advanced non small cell lung cancer: Paclitaxel, associated with cisplatinum is indicated for the treatment of non small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. Kaposis's sarcoma: In the second-line treatment of AIDS related Kaposi's sarcoma. For the treatment of advanced gastric carcinoma.
Contra-Indications:
Patients who have shown severe hypersensitivity to either paclitaxel or any of the excipients, or to macrogol glycerol ricinoleate, and patients with an initial blood count of <1,500 mm³ of neutrophils. Pregnancy. Discontinue breast feeding before treatment. See prescribing information for full details.
Special Precautions:
All patients must undergo prior treatment with corticosteroids, antihistaminic agents and H₂ antagonists. Regular monitoring of the cardiac function must be performed throughout therapy. Frequent monitoring of hematological parameters. Dental treatment should only be carried out in exceptional cases. Should not be administered to patients with severe hepatic dysfunction. Herpes zoster, varicella zoster, serious infections or bone marrow depression. Immunization with live virus vaccines should be avoided. See prescribing information for full details.
Side Effects:
Infections and infestations. Blood and lymphatic system disorders. Immune system disorders. Cardiac disorders. GI disorders. Alopecia, arthralgia and myalgia, injection site reactions. See prescribing information for full details.
Drug Interactions:
Administer before cisplatin, protease inhibitors (ritonavir, saquinar, indinavir and nelfinavir). Special care must be exercised when using in combination with known substrates or inhibitors of CYP3A4. Immunization with live virus vaccines should be avoided.