Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
gemcitabine hydrochloride (UNII: U347PV74IL) (gemcitabine - UNII:B76N6SBZ8R)
Sagent Pharmaceuticals
gemcitabine hydrochloride
gemcitabine 200 mg in 5 mL
INTRAVENOUS
PRESCRIPTION DRUG
Gemcitabine for Injection, USP in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. Gemcitabine for Injection, USP in combination with paclitaxel is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. Gemcitabine for Injection, USP in combination with cisplatin is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC). Gemcitabine for Injection, USP is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine for Injection, USP is indicated for patients previously treated with fluorouracil. Gemcitabine f
Gemcitabine for Injection, USP is supplied as follows: Gemcitabine for Injection, USP is a white to off-white, lyophilized powder. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Gemcitabine for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
GEMCITABINE- GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GEMCITABINE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE FOR INJECTION. GEMCITABINE FOR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Gemcitabine for Injection is a nucleoside metabolic inhibitor indicated: in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. (1.1) in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated. (1.2) in combination with cisplatin, for the treatment of non-small cell lung cancer. (1.3) as a single agent for the treatment of pancreatic cancer. (1.4) DOSAGE AND ADMINISTRATION Gemcitabine for Injection is for intravenous use only. Ovarian Cancer: 1000 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.1) Breast Cancer: 1250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.2) Non-Small Cell Lung Cancer: 1000 mg/m over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3) Pancreatic Cancer: 1000 mg/m over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly for 3 weeks of each 28-day cycle. (2.4) DOSAGE FORMS AND STRENGTHS Gemcitabine for Injection: 200 mg or 1 gram lyophilized powder in single-dose vials for reconstitution. (3) CONTRAINDICATIONS Patients with a known hypersensitivity to gemcitabine. (4) WARNINGS AND PRECAUTIONS Schedule-Dependent Toxicity: Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly. (5.1) Myelosuppression: Mo Baca dokumen lengkap