GEMCITABINE HYDROCHLORIDE injection, powder, lyophilized, for solution GEMCITABINE HYDROCHLORIDE injection, powder, lyophilized

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Accord Healthcare Inc.

INN (আন্তর্জাতিক নাম):

GEMCITABINE HYDROCHLORIDE

রচনা:

GEMCITABINE 200 mg in 5 mL

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 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 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 fluorouracil. Gemcitabine for Injection is contraind

পণ্য সারাংশ:

Gemcitabine for Injection is a sterile white to off-white lyophilized powder available in single-dose vials individually packaged in a carton containing 200 mg, 1g or 2 g gemcitabine: Gemcitabine for Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

GEMCITABINE HYDROCHLORIDE- GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
GEMCITABINE HYDROCHLORIDE - GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
ACCORD HEALTHCARE INC.
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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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions,
Hemolytic Uremic Syndrome ( 5.4)
5/2019
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
For injection: 200 mg or 1 gram or 2 gram lyophilized powder in
single-dose vials for reconstitution. ( 3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine. (4)
WARNINGS AND PRECAU