Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
gemcitabine hydrochloride (UNII: U347PV74IL) (gemcitabine - UNII:B76N6SBZ8R)
Bedford Laboratories
gemcitabine hydrochloride
gemcitabine 40 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Gemcitabine for injection 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 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 is indicated in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer. Gemcitabine for injection 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 is indicated for patients previously treated with 5-FU. Gemcitabine for injection is contraindicated in patie
Gemcitabine for Injection, USP is available in sterile single-use vials individually packaged in a carton containing: 200 mg white, lyophilized powder in a sterile single-use vial - NDC 55390-391-10. 1 g white, lyophilized powder in a sterile single-use vial – 55390-391-50. Unopened vials of gemcitabine for injection are stable until the expiration date indicated on the package when stored at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. [see Dosage and Administration ( 2.5 and 2.6 ) ].
Abbreviated New Drug Application
GEMCITABINE- GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BEDFORD LABORATORIES ---------- 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 RECENT MAJOR CHANGES Dosage and Administration:Dose Modifications for Non-Hematologic Adverse Reactions (2.5) 05/2014 Warnings and Precautions:Capillary Leak Syndrome (5.8) 05/2013 Posterior Reversible Encephalopathy Syndrome (5.9) 05/2014 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 200 mg vial for injection (3) 1 g vial for injection (3) CONTRAINDICATIONS Patients with a known hypersensitivity to Gemcitabine (4) WARNINGS AND PRECAUTION Прочитать полный документ