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Arthritis, Psoriasis

NANERCEPT

DESCRIPTION

 

 

Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kDa tumor necrosis factor receptor (TNFR) linked to the Fc portion of  human IgG1. The Fc  component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids and has a molecular weight of approximately 150 KDa.

The solution of Nanercept in the single-use prefilled syringe is clear and colourless, sterile, preservative-free, and is formulated at pH 6.3 ± 0.2.

COMPOSITION

 

 

Each single-use prefilled syringe is available in  25 mg (0.51 mL of a 50 mg/ mL solution of Etanecept) or 50 mg (0.98 mL of a 50 mg/ mL solution of Etanecept) dosage strengths.

THERAPEUTIC INDICATIONS

 

 

Rheumatoid Arthritis: Nanercept is indicated for reducing signs and symptoms, inducing major clinical responses, inhibiting the progression of structural damages, and improving physical function in patients having either moderately or  severely active rheumatoid arthritis (RA). Nanercept can be initiated in combination with Methotrexate (MTX) or used alone.

Polyarticular Juvenile Idiopathic Arthritis: Nanercept is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.

Nanercept is indicated for reducing signs and symptoms, inhibiting the progression of structural damages of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Nanercept can be used in combination with methotrexate (MTX) in patients who do not respond adequately to MTX alone.

Ankylosing Spondylitis: Nanercept is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).

Plaque Psoriasis: Nanercept is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

Adminstration route: SC injection

CONTRAINDICATIONS

 

 

Nanercept should not be administered to patients with sepsis.

STORAGE, SHELF-LIFE AND PACKING UNITS

 

 

Storage: at 2° to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep way from light.


Shelf life: 24 months from manufacturing date


Packing units


Box 01 prefilled syringe of Nanercept solution for injection (0.5 mL)


Box 01 vial of Nanercept solution for injection (1 mL)

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