Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)
Hospira, Inc.
GEMCITABINE HYDROCHLORIDE
GEMCITABINE 38 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Gemcitabine 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 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 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 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 is indicated for patients previously treated with fluorouracil. Gemcitabine is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include a
Gemcitabine for injection, USP is available is a sterile white to off-white lyophilized powder available in single-dose vials individually packaged in a carton containing 2 g gemcitabine: Gemcitabine 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°C and 30°C (59°F and 86°F) [ see USP Controlled Room Temperature].
Abbreviated New Drug Application
GEMCITABINE- GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HOSPIRA, INC. ---------- 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, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Warnings and Precautions, Hemolytic Uremic Syndrome (5.4) 5/2019 INDICATIONS AND USAGE Gemcitabine is a nucleoside metabolic inhibitor indicated: • • • • DOSAGE AND ADMINISTRATION Gemcitabine for injection, USP is for intravenous use only. • • • • DOSAGE FORMS AND STRENGTHS For injection: 2 gram lyophilized powder in single-dose vials for reconstitution. (3) CONTRAINDICATIONS Patients with a known hypersensitivity to gemcitabine. (4) WARNINGS AND PRECAUTIONS • • • • • • • • • ADVERSE REACTIONS The most common adverse reactions for the single agent (≥20%) are nausea/vomiting, anemia, increased 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) Ovarian Cancer: 1,000 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.1) 2 Breast Cancer: 1,250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.2) 2 Non-Small Cell Lung Cancer: 1,000 mg/m over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1,250 mg/m over 30 minutes on Days 1 and 8 of each 21-day cycle. (2.3) 2 2 Pancreatic Cancer: 1,000 mg/m over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly fo Прочетете целия документ