UPLIZNA Solution for injection Ref.[10302] Active ingredients:

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

Product description

Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight is approximately 149 kDa.

UPLIZNA (inebilizumab-cdon) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution, free from visible particles, for intravenous use.

Each single-dose vial contains 100 mg of inebilizumab in 10 mL of solution. Each mL contains 10 mg of inebilizumab-cdon, L-histidine (1.4 mg), L-histidine hydrochloride monohydrate (2.3 mg), polysorbate 80 (0.1 mg), sodium chloride (4.1 mg), α,α-trehalose dihydrate (40.1 mg), and Water for Injection, USP and a pH of 6.

Dosage Forms and Strengths

Injection: 100 mg/10 mL (10 mg/mL) clear to slightly opalescent, colorless to slightly yellow solution in a single-dose vial.

How Supplied

UPLIZNA (inebilizumab-cdon) injection is a clear to slightly opalescent, colorless to slightly yellow solution supplied as:

  • One carton containing three 100 mg/10 mL single-dose vials – NDC 72677-551-01.

Drugs

Drug Countries
UPLIZNA Estonia, Japan, United States

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