GEMCITABINE HYDROCHLORIDE injection, powder, lyophilized, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

BluePoint Laboratories

INN (שם בינלאומי):

GEMCITABINE HYDROCHLORIDE

הרכב:

GEMCITABINE 38 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

      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

leaflet_short:

Gemcitabine for Injection, USP, is supplied as follows: NDC Gemcitabine for Injection, USP 68001-282-22 200 mg/Vial 68001-282-23 1 g/Vial 68001-282-24 2 g/Vial 200 mg white to off-white, lyophilized powder sterile single-use-vial are packed individually per shelf pack with NDC 68001-282-25 1 g white to off-white, lyophilized powder sterile single-use-vial are packed individually per shelf pack with NDC 68001-282-26 2 g white to off-white, lyophilized powder sterile single-use-vial are packed individually per shelf pack with NDC 68001-282-27 Unopened vials of Gemcitabine for Injection 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)] .

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

GEMCITABINE HYDROCHLORIDE- GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
BLUEPOINT 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)
06/2014
Warnings and Precautions:
Posterior Reversible Encephalopathy Syndrome ( 5.9) 06/2014
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 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)
2 g/single-use vial ( 3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitab