KALBITOR Solution for injection Ref.[10232] Active ingredients: Ecallantide

Source: FDA, National Drug Code (US)  Revision Year: 2018 

Product description

KALBITOR (ecallantide) is a human plasma kallikrein inhibitor for injection for subcutaneous use. Ecallantide is a 60-amino-acid protein produced in Pichia pastoris yeast cells by recombinant DNA technology.

KALBITOR is a clear and colorless, sterile, and nonpyrogenic solution. Each vial contains 10 mg ecallantide as the active ingredient, and the following inactive ingredients: 0.76 mg disodium hydrogen orthophosphate (dihydrate), 0.2 mg monopotassium phosphate, 0.2 mg potassium chloride, and 8 mg sodium chloride in water for injection, USP. KALBITOR is preservative free, with a pH of approximately 7.0. A 30 mg dose is supplied as 3 vials each containing 1 mL of 10 mg/mL KALBITOR. Vials are intended for single use.

Dosage Forms and Strengths

KALBITOR is a clear, colorless liquid free of preservatives. Each vial of KALBITOR contains ecallantide at a concentration of 10 mg/mL.

How Supplied

KALBITOR (ecallantide) is supplied as three 10 mg/mL single-use vials packaged in a carton. Each vial contains 10 mg of ecallantide. Each vial contains a slight overfill.

  • NDC (47783-101-01): 3 single-use vials in 1 carton

Drugs

Drug Countries
KALBITOR United States

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