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GEMCITABINE medac
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GEMCITABINE medac
 
 
Package(a):
VIAL (powder for solution for infusion): 1 x 200 mg.
Dosage(a):
Should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy.
Non-Small Cell Lung Cancer: Combination use: Adults: Gemcitabine in combination with cisplatin has been investigated using two dosing regimens. One regimen used a three week schedule and the other used a four week schedule. The three week schedule used gemcitabine 1,250 mg/m2, given by 30 minute IV infusion, on days 1 and 8 of each 21 day cycle. The four week schedule used gemcitabine 1000 mg/m2, given by 30 minute IV infusion, on days 1, 8, 15 of each 28 day cycle. Cisplatin has been used at doses between 75-100 mg/m2 once every 3 or 4 weeks. Single-agent use: Adults: The recommended dose of gemcitabine is 1,000 mg/m2, given by 30 minute IV infusion. This should be repeated 1x weekly for three weeks, followed by a one week rest period. This four week cycle is then repeated. See prescribing information for full details. 
Breast cancer: Combination use: Adults: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3 hours as an IV infusion, followed by gemcitabine (1,250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle. See prescribing information for full details.
Pancreatic Cancer: Adults: The recommended dose of gemcitabine is 1,000 mg/m2given by 30¬minute IV infusion. This should be repeated 1 x weekly for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of injections 1 x weekly for 3 consecutive weeks out of every 4 weeks. See prescribing information for full details. 
Bladder Cancer: Combination use: Adults: The recommended dose for gemcitabine is 1,000 mg/m2, given by 30 minute infusion. The dose should be given on days 1, 8, and 15 of each 28 day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70 mg/m2 on day 1 following gemcitabine or day 2 of each 28 day cycle. This four week cycle is then repeated. See prescribing information for full details.
Ovarian cancer: Combination use: Adults: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1,000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute IV infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target AUC of 4.0 mg/ml*min. See prescribing information for full details.
Prescribing Restrictions:  None

Package(b):
VIAL (powder for solution for infusion): 1 x 1,000 mg.
Dosage(b):
Should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy.
Non-Small Cell Lung Cancer: Combination use: Adults: Gemcitabine in combination with cisplatin has been investigated using two dosing regimens. One regimen used a three week schedule and the other used a four week schedule. The three week schedule used gemcitabine 1,250 mg/m2, given by 30 minute IV infusion, on days 1 and 8 of each 21 day cycle. The four week schedule used gemcitabine 1000 mg/m2, given by 30 minute IV infusion, on days 1, 8, 15 of each 28 day cycle. Cisplatin has been used at doses between 75-100 mg/m2 once every 3 or 4 weeks. Single-agent use: Adults: The recommended dose of gemcitabine is 1,000 mg/m2, given by 30 minute IV infusion. This should be repeated 1x weekly for three weeks, followed by a one week rest period. This four week cycle is then repeated. See prescribing information for full details. 
Breast cancer: Combination use: Adults: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3 hours as an IV infusion, followed by gemcitabine (1,250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle. See prescribing information for full details.
Pancreatic Cancer: Adults: The recommended dose of gemcitabine is 1,000 mg/m2given by 30¬minute IV infusion. This should be repeated 1 x weekly for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of injections 1 x weekly for 3 consecutive weeks out of every 4 weeks. See prescribing information for full details. 
Bladder Cancer: Combination use: Adults: The recommended dose for gemcitabine is 1,000 mg/m2, given by 30 minute infusion. The dose should be given on days 1, 8, and 15 of each 28 day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70 mg/m2 on day 1 following gemcitabine or day 2 of each 28 day cycle. This four week cycle is then repeated. See prescribing information for full details.
Ovarian cancer: Combination use: Adults: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1,000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute IV infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target AUC of 4.0 mg/ml*min. See prescribing information for full details.
Prescribing Restrictions:  None

Package(c):
VIAL (powder for solution for infusion): 1 x 1,500 mg.
Dosage(c):
Should only be prescribed by a physician qualified in the use of anti-cancer chemotherapy.
Non-Small Cell Lung Cancer: Combination use: Adults: Gemcitabine in combination with cisplatin has been investigated using two dosing regimens. One regimen used a three week schedule and the other used a four week schedule. The three week schedule used gemcitabine 1,250 mg/m2, given by 30 minute IV infusion, on days 1 and 8 of each 21 day cycle. The four week schedule used gemcitabine 1000 mg/m2, given by 30 minute IV infusion, on days 1, 8, 15 of each 28 day cycle. Cisplatin has been used at doses between 75-100 mg/m2 once every 3 or 4 weeks. Single-agent use: Adults: The recommended dose of gemcitabine is 1,000 mg/m2, given by 30 minute IV infusion. This should be repeated 1x weekly for three weeks, followed by a one week rest period. This four week cycle is then repeated. See prescribing information for full details. 
Breast cancer: Combination use: Adults: Gemcitabine in combination with paclitaxel is recommended using paclitaxel (175 mg/m2) administered on Day 1 over approximately 3 hours as an IV infusion, followed by gemcitabine (1,250 mg/m2) as a 30-minute intravenous infusion on Days 1 and 8 of each 21-day cycle. See prescribing information for full details.
Pancreatic Cancer: Adults: The recommended dose of gemcitabine is 1,000 mg/m2given by 30¬minute IV infusion. This should be repeated 1 x weekly for up to 7 weeks, followed by a week of rest. Subsequent cycles should consist of injections 1 x weekly for 3 consecutive weeks out of every 4 weeks. See prescribing information for full details. 
Bladder Cancer: Combination use: Adults: The recommended dose for gemcitabine is 1,000 mg/m2, given by 30 minute infusion. The dose should be given on days 1, 8, and 15 of each 28 day cycle in combination with cisplatin. Cisplatin is given at a recommended dose of 70 mg/m2 on day 1 following gemcitabine or day 2 of each 28 day cycle. This four week cycle is then repeated. See prescribing information for full details.
Ovarian cancer: Combination use: Adults: Gemcitabine in combination with carboplatin is recommended using gemcitabine 1,000 mg/m2 administered on Days 1 and 8 of each 21-day cycle as a 30-minute IV infusion. After gemcitabine, carboplatin will be given on Day 1 consistent with a target AUC of 4.0 mg/ml*min. See prescribing information for full details.
Prescribing Restrictions:  None


Indications:
200 mg, 1,000 mg: Palliative treatment of patients with locally advanced or metastatic non-small cell lung cancer and locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer. Treatment of patients with bladder cancer at the invasive stage. Breast cancer: In combination with paclitaxel for the treatment of patients with unresectable locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Ovarian cancer: In combination with carboplatin for the treatment of patients with recurrent epithelial ovarian carcinoma whom have relapsed at least six months after platinum-based therapy.
1,500 mg: Treatment of locally advanced or metastatic bladder cancer in combination with cisplatin. Treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. In combination with cisplatin as first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Monotherapy can be considered in elderly patients or those with performance status 2. Treatment of patients with locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, first-line therapy. In combination with paclitaxel, for the treatment of patients with unresectable, locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated.
Contra-Indications:
Hypersensitivity to the active substance or to any of the excipients. Lactation.
Special Precautions:
See prescribing information for full details.
Side Effects:
See prescribing information for full details.
Drug Interactions:
See prescribing information for full details.