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

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

entecavir monohydrate, Quantity: 1.064 mg

Fáanlegur frá:

Cipla Australia Pty Ltd

INN (Alþjóðlegt nafn):

entecavir monohydrate

Lyfjaform:

Tablet, film coated

Samsetning:

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

Stjórnsýsluleið:

Oral

Einingar í pakka:

10, 30

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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.

Vörulýsing:

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

Leyfisstaða:

Licence status A

Leyfisdagur:

2016-12-19