CIPLA ENTECAVIR entecavir (as monohydrate) 1mg film coated tablets

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

entecavir monohydrate, Quantity: 1.064 mg

Disponible desde:

Cipla Australia Pty Ltd

Designación común internacional (DCI):

entecavir monohydrate

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; hyprolose; titanium dioxide; hypromellose; iron oxide red; macrogol 400

Vía de administración:

Oral

Unidades en paquete:

10, 30

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

CIPLA ENTECAVIR is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.,This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment na?ve and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Resumen del producto:

Visual Identification: pink coloured, triangular shaped, biconvex, film coated tablet, debossed with 'E' on one side and "1" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Licence status A

Fecha de autorización:

2016-12-19