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NDC 16729-0295-31

Carboplatin 10 mg/mL INJECTION

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NDC
16729-0295-31
Generic Name
Carboplatin
Brand Name
Carboplatin
Strength
10 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Package Size
—
Labeler
Accord Healthcare, Inc.

FDA Drug Information

Indications & Usage

INDICATIONS Initial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival betwee…

Important Warnings

WARNINGS Bone marrow suppression (leukopenia, neutropenia, and thrombocytopenia) is dose-dependent and is also the dose-limiting toxicity. Peripheral blood counts should be frequently monitored during carboplatin injection treatment and, when appropriate, until recovery is achieved. Median nadir occurs at day 21 in patients receiving single agent carboplatin. In general, single intermittent course…

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

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