GEMCITABINE HYDROCHLORIDE- gemcitabine hydrochloride injection, powder, lyophilized, for solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)

可用日期:

Heritage Pharmaceuticals Inc.

INN（国际名称）:

GEMCITABINE HYDROCHLORIDE

组成:

GEMCITABINE 200 mg in 5 mL

给药途径:

INTRAVENOUS

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 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 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 5-FU. Gemcitabine for Injection USP is contraindicated in patients with a known hypersensitivity to gemcitabine. Pregnancy Catego

產品總結:

Gemcitabine for Injection USP is available in sterile single-use vials individually packaged in a carton containing: 200 mg white to off-white, lyophilized powder in a 10-mL size sterile single-use vial - NDC 23155-483-31 1 g white to off-white, lyophilized powder in a 50-mL size sterile single-use vial - NDC 23155-484-31 Unopened vials of Gemcitabine for Injection USP are stable until the expiration date indicated on the package 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) [See USP Controlled Room Temperature] [see Dosage and Administration (2.5 and 2.6)] .

授权状态:

Abbreviated New Drug Application

产品特点

GEMCITABINE HYDROCHLORIDE- GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
HERITAGE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE FOR INJECTION USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE FOR
INJECTION USP.
GEMCITABINE FOR INJECTION USP, 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 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 USP 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 21day
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/single-use vial (3)
1 g/single-use vial (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemc