WYOST Solution for injection Ref.[109628] Active ingredients: Denosumab

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

Denosumab-bbdz is a human IgG2 monoclonal antibody that binds to human RANKL. Denosumab-bbdz has an approximate molecular weight of 147 kDa and is produced in genetically engineered mammalian (Chinese hamster ovary) cells.

Wyost (denosumab-bbdz) injection is a sterile, preservative-free, clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution for subcutaneous use.

Each single-dose vial of Wyost contains 120 mg denosumab-bbdz, glacial acetic acid (1.85 mg), polysorbate 20 (0.17 mg), sodium hydroxide (0.91 mg), sorbitol (78.9 mg), and Water for Injection (USP) with a pH of 5.2.

Hydrochloric acid and sodium hydroxide may be added to adjust pH.

Dosage Forms and Strengths

Injection: 120 mg/1.7 mL (70 mg/mL) clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution in a single-dose vial.

How Supplied

Wyost injection is a clear to slightly opalescent and colorless to slightly yellowish to slightly brownish solution supplied in a single-dose vial. The vial stopper is not made with natural rubber latex.

120 mg/1.7 mL (70 mg/mL) 1 vial per cartonNDC 61314-228-94

Manufactured by: Sandoz Inc., Princeton, NJ 08540, U.S. License No. 2003

Drugs

Drug Countries
WYOST Canada, Lithuania, United States

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