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GEMCITABINE TEVA
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 GEMCITABINE TEVA
 
Package(a):
VIAL (powder for solution for injection): 1 x 200 mg.
Dosage(a):
This product must be administered by healthcare professionals experienced in the administration of chemotherapeutic drugs.
Non-small cell lung cancer: IV infusion at a dose of 1 g/m2 over 30 minutes once weekly for 3 consecutive weeks, followed by 1 week rest period. This 4-cycle is to be repeated.
Breast cancer: To be given in combination with paclitaxel as follows: It is recommended to administer paclitaxel (175 mg/m2 on Day 1 over approximately 3 hours as an IV infusion, followed by Gemcitabine Teva (1,250 mg/m2) as a 30-minute IV infusion on Days 1 and 8 of each 21-day cycle.
Pancreatic cancer: Gemcitabine Teva should be used by IV infusion at a dose of 1,000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by one week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.
Bladder cancer: Gemcitabine Teva should be administered by IV infusion at a dose of 1,000 mg/m2 over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 70 mg/m2 on Day 1 of each 28-day cycle. This 4-week schedule is then repeated.
Ovarian cancer: Gemcitabine Teva 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. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Please contact distributing company for more detailed dosing and dosage adjustments.
Pediatrics (< 17 years of age): Safety and effectiveness in children younger than 17 years have not been established.
Prescribing Restrictions:  None

Package(b):
VIAL (powder for solution for injection): 1 x 1 g.
Dosage(b):
This product must be administered by healthcare professionals experienced in the administration of chemotherapeutic drugs.
Non-small cell lung cancer: IV infusion at a dose of 1 g/m2 over 30 minutes once weekly for 3 consecutive weeks, followed by 1 week rest period. This 4-cycle is to be repeated.
Breast cancer: To be given in combination with paclitaxel as follows: It is recommended to administer paclitaxel (175 mg/m2 on Day 1 over approximately 3 hours as an IV infusion, followed by Gemcitabine Teva (1,250 mg/m2) as a 30-minute IV infusion on Days 1 and 8 of each 21-day cycle.
Pancreatic cancer: Gemcitabine Teva should be used by IV infusion at a dose of 1,000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by one week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.
Bladder cancer: Gemcitabine Teva should be administered by IV infusion at a dose of 1,000 mg/m2 over 30 minutes on Days 1, 8 and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 70 mg/m2 on Day 1 of each 28-day cycle. This 4-week schedule is then repeated.
Ovarian cancer: Gemcitabine Teva 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. Dosage reduction with each cycle or within a cycle may be applied based upon the amount of toxicity experienced by the patient.
Please contact distributing company for more detailed dosing and dosage adjustments.
Pediatrics (< 17 years of age): Safety and effectiveness in children younger than 17 years have not been established.
Prescribing Restrictions:  None


Indications:
Non-Small Cell Lung Cancer: Palliative treatment of adult patients with locally advanced or metastatic non-small cell lung cancer.
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. 
Pancreatic Cancer: Palliative treatment of adult patients with locally advanced or metastatic adenocarcinoma of the pancreas and for patients with 5-FU refractory pancreatic cancer.
Bladder Cancer: Treatment of patients with bladder cancer at the invasive stage. 
Ovarian cancer: In combination with carboplatin, for the treatment of patients with recurrent epithelial ovarian carcinoma who have relapsed at least 6 months after platinum-based therapy.
Contra-Indications:
Known hypersensitivity to gemcitabine or to any other ingredient of the preparation.
Special Precautions:
Please contact distributing company for full details.
Side Effects:
Please contact distributing company for full details.
Drug Interactions:
Please contact distributing company for full details.