AVSOLA Powder for solution for injection Ref.[10753] Active ingredients: Infliximab

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

Product description

Infliximab-axxq, the active ingredient in AVSOLA, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions) specific for human tumor necrosis factor-alpha (TNFα). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-axxq is produced in a recombinant Chinese Hamster Ovary (CHO) cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.

AVSOLA is supplied as a sterile, white to slightly yellow, lyophilized powder for intravenous infusion. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the resulting pH is approximately 7.2. Each single-dose vial contains 100 mg infliximab-axxq, dibasic sodium phosphate, anhydrous (4.9 mg), monobasic sodium phosphate, monohydrate (2.2 mg), polysorbate 80 (0.5 mg), and sucrose (500 mg).

No preservatives are present.

Dosage Forms and Strengths

For injection: 100 mg of infliximab-axxq as a white to slightly yellow lyophilized powder in a single-dose vial, for intravenous use.

How Supplied

Each AVSOLA (infliximab-axxq) for Injection 20 mL vial is individually packaged in a carton.

AVSOLA is supplied as a single carton containing 1 vial.

NDC 55513-670-01 100 mg vial

Each single-dose vial contains 100 mg of infliximab-axxq for final reconstitution volume of 10 mL.

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799

Drugs

Drug Countries
AVSOLA Brazil, Canada, Turkey, United States

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