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NDC 16729-0115-05

Mitomycin 5 mg/10mL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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NDC
16729-0115-05
Generic Name
Mitomycin
Brand Name
Mitomycin
Strength
5 mg/10mL
Dosage Form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Package Size
Labeler
Accord Healthcare, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS AND USAGE Mitomycin for Injection is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.

Important Warnings

WARNINGS Patients being treated with mitomycin must be observed carefully and frequently during and after therapy. The use of mitomycin results in a high incidence of bone marrow suppression, particularly thrombocytopenia and leukopenia. Therefore, the following studies should be obtained repeatedly during therapy and for at least eight weeks following therapy: platelet count, white blood cell cou…

Source: FDA. For professional use only. Not a substitute for prescribing information.

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