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gemcitabine injection solution

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gemcitabine injection solution Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Ovarian Cancer

Gemcitabine Injection in combination with carboplatin is indicated for the treatment of patients with advanced...

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2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule...

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3 DOSAGE FORMS AND STRENGTHS

Injection: 200 mg/5.26 mL (38 mg/mL), 1 g/26.3 mL (38 mg/mL), and 2 g/52.6 mL (38 mg/mL) as a clear and colorless to light straw-colored solution in a single-dose vial.

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4 CONTRAINDICATIONS

Gemcitabine Injection is contraindicated in patients with a known hypersensitivity to gemcitabine. Reactions include anaphylaxis [see Adverse Reactions (6. 1)]...

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5 WARNINGS AND PRECAUTIONS

5.1 Schedule-Dependent Toxicity

In clinical trials evaluating the maximum tolerated dose of gemcitabine, prolongation of the infusion...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity [see

    6.1 Clinical Trials Experience

    ...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on animal data...

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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 5700 mg/m2 was...

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11 DESCRIPTION

Gemcitabine is a nucleoside metabolic inhibitor. The chemical name of gemcitabine HCl is 2´-deoxy-2´,2´-difluorocytidine monohydrochloride (β-isomer). The structural formula is as follows:

...
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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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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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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 that...

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15 REFERENCES

1. OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

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16 HOW SUPPLIED/STORAGE AND HANDLING

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:

...
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17 PATIENT COUNSELING INFORMATION

Myelosuppression

Advise patients of the risks of myelosuppression. Instruct patients to immediately...

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Distributed by Hospira, Inc. Lake Forest, IL 60045 USA

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