ANTHIM Solution for injection Ref.[10346] Active ingredients: Obiltoxaximab

Source: FDA, National Drug Code (US)  Revision Year: 2019 

Product description

Obiltoxaximab is a chimeric IgG1 kappa monoclonal antibody (mAb) that binds the PA component of B. anthracis toxin. It has an approximate molecular weight of 148 kDa.

ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates. ANTHIM is supplied as 600 mg/6 mL in single-dose vials for intravenous infusion. Each mL contains 100 mg obiltoxaximab in L-histidine (6.2 mg), polysorbate 80 (0.1 mg), sorbitol (36 mg) with a pH of 5.5.

Dosage Forms and Strengths

Injection: 600 mg/6 mL (100 mg/mL) in a single-dose vial.

ANTHIM is a clear to opalescent, colorless to pale yellow to pale brownish-yellow solution and may contain few translucent-to-white proteinaceous particulates.

How Supplied

ANTHIM injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brownish-yellow solution that may contain few translucent-to-white proteinaceous particulates in single-dose vials containing 600 mg/6 mL (100 mg/mL) and is available in the following packaging configuration:

Carton: Contains one (1) single-dose vial of ANTHIM 600 mg/6 mL (NDC 69604-204-02).

Drugs

Drug Countries
ANTHIM United States

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