GEMCITABINE injection, powder, lyophilized, for 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 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 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 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 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 is indicated for patients previously treated with fluorouracil. Gemcitabine is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include a

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

GEMCITABINE- GEMCITABINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
----------
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 is a nucleoside metabolic inhibitor indicated:
•
•
•
•
DOSAGE AND ADMINISTRATION
Gemcitabine for injection, USP is for intravenous use only.
•
•
•
•
DOSAGE FORMS AND STRENGTHS
For injection: 2 gram lyophilized powder in single-dose vials for
reconstitution. (3)
CONTRAINDICATIONS
Patients with a known hypersensitivity to gemcitabine. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions for the single agent (≥20%) are
nausea/vomiting, anemia, increased
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: 1,000 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle. (2.1)
2
Breast Cancer: 1,250 mg/m over 30 minutes on Days 1 and 8 of each
21-day cycle. (2.2)
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)
2
2
Pancreatic Cancer: 1,000 mg/m over 30 minutes once weekly for the
first 7 weeks, then one week
rest, then once weekly fo