GEMCITABINE hydrochloride injection powder lyophilized for solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Sun Pharma Global FZE

INN (Միջազգային անվանումը):

GEMCITABINE HYDROCHLORIDE

Կազմը:

GEMCITABINE 200 mg in 5 mL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

GEMCITABINE - GEMCITABINE HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
SUN PHARMA GLOBAL FZE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GEMCITABINE.
GEMCITABINE FOR INJECTION USP, 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: 1,000 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle (2.1)
Breast Cancer: 1,250 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle (2.2)
Non-Small Cell Lung Cancer: 1,000 mg/m over 30 minutes on Days 1, 8,
and 15 of each 28-day cycle or 1,250 mg/m
over 30 minutes on Days 1 and 8 of each 21-day cycle (2.3)
Pancreatic Cancer: 1,000 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 gemcitabine (4)
WARNINGS AND PRECAUTIONS
Schedule-dependent toxicity: Increased toxicity with infusion time
greater th