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gemcitabine injection powder 2GM
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gemcitabine injection powder 2GM Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Ovarian Cancer
Gemcitabine in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Ovarian Cancer
Recommended Dose and Schedule
The...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
For injection: 2 g gemcitabine as a sterile white to off-white lyophilized powder in a single-dose vial for reconstitution.
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Contraindications
4 CONTRAINDICATIONS
Gemcitabine is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6.1)].
...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Schedule-Dependent Toxicity
In clinical trials evaluating the maximum tolerated dose of gemcitabine, prolongation of the infusion time...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity [see Contraindications (4)] ...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on animal data...
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Overdosage
10 OVERDOSAGE
There is no known antidote for overdoses of gemcitabine. Myelosuppression, paresthesias, and severe rash were the principal toxicities seen when a single dose as high as 5,700 mg/m2 was...
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Description
11 DESCRIPTION
Gemcitabine is a nucleoside metabolic inhibitor. Gemcitabine hydrochloride is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer) with the following structural formula:
...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term animal studies to evaluate the carcinogenic potential of gemcitabine...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Ovarian Cancer
The efficacy of gemcitabine was evaluated in a randomized trial (Study 1) conducted in women with advanced ovarian cancer...
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References
15 REFERENCES
1. OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
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...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Myelosuppression
Advise patients of the risks of myelosuppression. Instruct patients to immediately...
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