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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Sagent Pharmaceuticals

INN (International Name):

gemcitabine hydrochloride

Sammensetning:

gemcitabine 200 mg in 5 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Gemcitabine for Injection, USP 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, USP 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, USP 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 for Injection, USP 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, USP is indicated for patients previously treated with fluorouracil. Gemcitabine f

Produkt oppsummering:

Gemcitabine for Injection, USP is supplied as follows: Gemcitabine for Injection, USP is a white to off-white, lyophilized powder. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. Gemcitabine for Injection, USP 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° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

GEMCITABINE- GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED,
FOR
SOLUTION
SAGENT PHARMACEUTICALS
----------
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
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
Gemcitabine for Injection: 200 mg or 1 gram lyophilized powder in
single-dose vials for reconstitution. (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: Mo