APOTEX-Adefovir adefovir dipivoxil 10mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adefovir dipivoxil, Quantity: 10 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Adefovir dipivoxil

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: lactose monohydrate; pregelatinised maize starch; purified talc; magnesium stearate; croscarmellose sodium

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

? Adefovir dipivoxil is indicated for the treatment of chronic hepatitis B in patients 12 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. ? For adult patients, this indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg-/HBVDNA+ chronic hepatitis B with compensated liver function, and in adult patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function. ? For adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus with compensated liver function.

Product summary:

Visual Identification: White to off-white, round, flat-faced bevelled edge tablet. Engraved "APO" on one side, "A10" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-05-12