GEMCITABINE injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hospira, Inc.

INN (Διεθνής Όνομα):

GEMCITABINE HYDROCHLORIDE

Σύνθεση:

GEMCITABINE 38 mg in 1 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Gemcitabine 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 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 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 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 Injection is indicated for patients previously treated with fluorouracil. Gemcitabine Injection is contraindicated in patients with

Περίληψη προϊόντος:

Gemcitabine Injection appears as a clear and colorless to light straw-colored solution. It is available in sterile single-dose vials individually packaged in a carton as follows: Store at 2° to 8°C (36° to 46°F). Do not freeze. Gemcitabine Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

GEMCITABINE- GEMCITABINE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEMCITABINE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
GEMCITABINE INJECTION.
GEMCITABINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Warnings and Precautions, Hemolytic Uremic Syndrome (5.4)
6/2019
INDICATIONS AND USAGE
Gemcitabine Injection is a nucleoside metabolic inhibitor indicated:
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DOSAGE AND ADMINISTRATION
Gemcitabine Injection is for intravenous use only.
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DOSAGE FORMS AND STRENGTHS
Injection: 200 mg/5.26 mL (38 mg/mL), 1 g/26.3 mL (38 mg/mL), or 2
g/52.6 mL (38 mg/mL) in a single-
dose vial. (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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)
Ovarian Cancer: 1000 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle. (2.1)
2
Breast Cancer: 1250 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle. (2.2)
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)
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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)
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Schedule-Dependent Toxicity: Increased toxicity with infusion time
greater