GEMCITABINE injection, powder, lyophilized, for solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

gemcitabine hydrochloride (UNII: U347PV74IL) (gemcitabine - UNII:B76N6SBZ8R)

Boleh didapati daripada:

Bedford Laboratories

INN (Nama Antarabangsa):

gemcitabine hydrochloride

Komposisi:

gemcitabine 40 mg in 1 mL

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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 ) ].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

GEMCITABINE- GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
BEDFORD LABORATORIES
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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