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gemcitabine injection powder 1GM, 200MG

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

gemcitabine injection powder 1GM, 200MG 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 in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that...

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2 DOSAGE AND ADMINISTRATION

2.1 Ovarian Cancer

Recommended Dose and Schedule

The...

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3 DOSAGE FORMS AND STRENGTHS

For injection: 200 mg gemcitabine or 1 g gemcitabine as a sterile white to off-white lyophilized powder in a single-dose vial for reconstitution.

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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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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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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 5,700 mg/m2...

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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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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 for Injection, USP is a sterile white to off-white lyophilized powder available in single-dose vials individually packaged in a carton containing 200 mg or 1 g gemcitabine:...

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17 PATIENT COUNSELING INFORMATION

Myelosuppression

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

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