Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: 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 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 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 Injection 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 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 Injection is indicated for patients previously treated with fluorouracil. Gemcitabine Injection is contraindicated in patients with
Gemcitabine Injection appears as a clear and colorless to light straw-colored solution. It is available in sterile single-dose vials individually packaged in a carton as follows: Store at 2° to 8°C (36° to 46°F). Do not freeze. Gemcitabine Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
New Drug Application
GEMCITABINE- GEMCITABINE INJECTION, SOLUTION HOSPIRA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GEMCITABINE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE INJECTION. GEMCITABINE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1996 RECENT MAJOR CHANGES Warnings and Precautions, Hemolytic Uremic Syndrome (5.4) 6/2019 INDICATIONS AND USAGE Gemcitabine 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 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 Injection: 200 mg/5.26 mL (38 mg/mL), 1 g/26.3 mL (38 mg/mL), or 2 g/52.6 mL (38 mg/mL) in a single-dose vial. (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: Monitor for Izlasiet visu dokumentu