GEMCITABINE HYDROCHLORIDE injection powder lyophilized for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

hameln rds gmbh

INN (الاسم الدولي):

gemcitabine hydrochloride

تركيب:

gemcitabine 200 mg in 5 mL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

GEMCITABINE HYDROCHLORIDE- GEMCITABINE HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
HAMELN RDS GMBH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE FOR INJECTION USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GEMCITABINE FOR
INJECTION USP.
GEMCITABINE FOR INJECTION USP (GEMCITABINE FOR INJECTION) POWDER,
LYOPHILIZED, FOR SOLUTION
FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Gemcitabine for Injection USP is a nucleoside metabolic inhibitor
indicated for:
Ovarian cancer in combination with carboplatin (_1.1_)
Breast cancer in combination with paclitaxel (_1.2_)
Non-small cell lung cancer in combination with cisplatin (_1.3_)
Pancreatic cancer as a single-agent (_1.4_)
DOSAGE AND ADMINISTRATION
Gemcitabine for Injection USP 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: 4-week schedule; 1000 mg/m over 30 minutes
on Days 1, 8, and 15 of each 28-day cycle:
3-week schedule; 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 up to 7
weeks (or until toxicity necessitates reducing
or holding a dose), followed by a week of rest from treatment.
Subsequent cycles should consist of infusions once
weekly for 3 consecutive weeks out of every 4 weeks (_2.4_)
Dose Reductions or discontinuation may be needed based on toxicities
(_2.1-2.4_)
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 PRECAUTIONS
Infusion time and dose frequency: Increased toxicity with infusion
time >60 minutes or dosing more frequently than
once weekly. (_5.1_)
Hematology: Monitor for myelosuppression, which can be dose-limiting.
(_5.2, 5.