CINQAIR Solution for injection Ref.[10775] Active ingredients: Reslizumab

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4Îș). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa.

CINQAIR is a sterile, preservative-free, clear to slightly hazy/opalescent, colorless to slightly yellow solution (injection) for intravenous infusion. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent to white, amorphous particulates. Each single-use vial contains 100 mg reslizumab in 10 mL. Each mL contains 10 mg of reslizumab, glacial acetic acid (0.12 mg), sodium acetate trihydrate (2.45 mg), and sucrose (70 mg), with a pH of 5.5.

Dosage Forms and Strengths

Injection: 100 mg/10 mL (10 mg/mL), clear to slightly hazy/opalescent, colorless to slightly yellow solution in single-use vials.

How Supplied

CINQAIR (reslizumab) injection, 100 mg/10 mL (10 mg/mL), is supplied as a preservative-free, sterile, clear to slightly hazy/opalescent, colorless to slightly yellow solution in single-use vials. The following packaging configuration is available:

  • NDC 59310-610-31: 100 mg/10 mL (10 mg/mL) single-use vial.

Manufactured by: Teva Respiratory, LLC, West Chester, PA 19380

Drugs

Drug Countries
CINQAIR Canada, Israel, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.