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TOPOTECAN TEVA

Package(a):
VIALS (concentrate for solution for infusion): 1 x 1 ml.
Dosage(a):
Must be diluted before use. 
Ovarian and Small Cell Lung Carcinoma: Initial dose: 1.5 mg/m² body surface area/daily administered by IV infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course. If well tolerated, treatment may continue until disease progression.
Cervical Carcinoma: Initial dose: 0.75 mg/m²/daily administered as 30 minute IV infusion daily on days 1, 2 and 3. Cisplatin is administered as IV infusion on day 1 at a dose of 50 mg/m²/daily and following the topotecan dose. This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Subsequent doses: Should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10⁹/l, the platelet count is more than or equal to 100 x 10⁹/l, and the hemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary). 
Dosage in renally and hepatically impaired patients: See literature. 
Children: Not recommended.
Prescribing Restrictions:  None

Package(b):
VIALS (concentrate for solution for infusion): 5 x 1 ml.
Dosage(b):
Must be diluted before use. 
Ovarian and Small Cell Lung Carcinoma: Initial dose: 1.5 mg/m² body surface area/daily administered by IV infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course. If well tolerated, treatment may continue until disease progression.
Cervical Carcinoma: Initial dose: 0.75 mg/m²/daily administered as 30 minute IV infusion daily on days 1, 2 and 3. Cisplatin is administered as IV infusion on day 1 at a dose of 50 mg/m²/daily and following the topotecan dose. This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Subsequent doses: Should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10⁹/l, the platelet count is more than or equal to 100 x 10⁹/l, and the hemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary). 
Dosage in renally and hepatically impaired patients: See literature. 
Children: Not recommended.
Prescribing Restrictions:  None

Package(c):
VIALS (concentrate for solution for infusion): 1 x 4 ml.
Dosage(c):
Must be diluted before use. 
Ovarian and Small Cell Lung Carcinoma: Initial dose: 1.5 mg/m² body surface area/daily administered by IV infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course. If well tolerated, treatment may continue until disease progression.
Cervical Carcinoma: Initial dose: 0.75 mg/m²/daily administered as 30 minute IV infusion daily on days 1, 2 and 3. Cisplatin is administered as IV infusion on day 1 at a dose of 50 mg/m²/daily and following the topotecan dose. This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Subsequent doses: Should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10⁹/l, the platelet count is more than or equal to 100 x 10⁹/l, and the hemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary). 
Dosage in renally and hepatically impaired patients: See literature. 
Children: Not recommended.
Prescribing Restrictions:  None

Package(d):
VIALS (concentrate for solution for infusion): 5 x 4 ml.
Dosage(d):
Must be diluted before use. 
Ovarian and Small Cell Lung Carcinoma: Initial dose: 1.5 mg/m² body surface area/daily administered by IV infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course. If well tolerated, treatment may continue until disease progression.
Cervical Carcinoma: Initial dose: 0.75 mg/m²/daily administered as 30 minute IV infusion daily on days 1, 2 and 3. Cisplatin is administered as IV infusion on day 1 at a dose of 50 mg/m²/daily and following the topotecan dose. This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Subsequent doses: Should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10⁹/l, the platelet count is more than or equal to 100 x 10⁹/l, and the hemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary). 
Dosage in renally and hepatically impaired patients: See literature. 
Children: Not recommended.
Prescribing Restrictions:  None


Indications:
Treatment of metastatic carcinoma of the ovary after failure of initial or subsequent therapy.
Treatment of small cell lung cancer sensitive disease after failure of first line chemotherapy.
In combination with cisplatin, for the treatment of Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
Contra-Indications:
History of severe hypersensitivity to the active substance or to any of the excipients. Pregnancy and lactation. Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 10⁹/l and/or a platelet count < 100 x 10⁹/l.
Special Precautions:
Please contact distributing company for full details.
Side Effects:
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Drug Interactions:
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