| Composition : | Each lyophilized vial contains:
Gemcitabine Hydrochloride
equivalent to Gemcitabine………..200mg , 1000mg, 1400mg
• Mannitol…………………………..200 mg, 1000mg, 1400mg |
| Indication : | Gemcitabine hcl in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer.
• Gemcitabine hcl in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer.
• Gemcitabine hcl is indicated in combination with cisplatin for the first-line treatment of patients with non-small cell lung cancer.
Gemcitabine hcl is indicated as first-line treatment for patients with adenocarcinoma of the pancreas. Gemcitabine hcl is indicated for patients previously treated with 5-FU |
| Dosage :- | Adult : Administered i.v. at a dose of 1000 mg/m² over 30 minutes, once weekly for upto 7 weeks or if toxicity calls for reducing or holding a dose. Followed by a week of rest from treatment subsequent cycles consist of infusions one weekly for three weeks out of every 4 weeks. |
| Contra Indications :- | Gemcitabine hcl is contraindicated in those patients with a known hypersensitivity to the drug. |
| Adverse effect :- | Most adverse reactions are reversible and do not need to result in discontinuation, although doses may need to be withheld or reduced. Myelosuppression, Nausea and vomiting, mild proteinuria and hematuria, fever, rash, dyspnea, edema, infection, alopecia, bronchospasm
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| Storage: | Gemcitabine hcl are stable when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F)
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| Pharmacological action: B> | Gemcitabine exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and also blocking the progression of cells through the Gl/S-phase boundary. Gemcitabine is metabolized intracellular by nucleoside kinases to the active diphosphate and triphosphate nucleosides. |
| Specification: - | Gemcitabine for injection is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HC1 is 2'-deoxy-2',2'-difluorocytidine monohydrochloride (β-isomer). The empirical formula for Gemcitabine HC1 is C9H11F2N3O4•HCI It has a molecular weight of 299.66. Gemcitabine HC1 is a white to off-white solid. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents |
| Drug Interactions :- | No specific drug interaction studies have been conducted. |
| Purity : | Not less than 99%. |
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