ENTECAVIR VIATRIS entecavir (as monohydrate) 0.5 mg film coated tablets bottle

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

entecavir, Quantity: 0.5 mg

Disponible depuis:

Alphapharm Pty Ltd

DCI (Dénomination commune internationale):

entecavir monohydrate

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; crospovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; macrogol 400

Mode d'administration:

Oral

Unités en paquet:

30

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

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 lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Descriptif du produit:

Visual Identification: A white, film-coated, round, biconvex, beveled edge tablet debossed with 'M' on one side of the tablet and 'EV1' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

2016-04-18

Résumé des caractéristiques du produit

AUSTRALIAN PRODUCT INFORMATION
ENTECAVIR MYLAN
_entecavir (as monohydrate) film coated tablets _
1
NAME OF THE MEDICINE
Entecavir (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ENTECAVIR MYLAN tablet contains 0.5 mg or 1 mg of entecavir (as
monohydrate).
Excipients with known effects: sugars (as lactose).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ENTECAVIR MYLAN
0.5 mg
:
A white, film-coated, round, biconvex, beveled edge tablet debossed
with
‘M’ on one side of the tablet and ‘EV1’ on the other side.
ENTECAVIR MYLAN
1 mg
:
A white, film-coated, round, biconvex, beveled edge tablet debossed
with
‘M’ on one side of the tablet and ‘EV2’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 naïve and lamivudine-resistant adult patients with
HBeAg-positive or HBeAg-negative chronic
HBV infection with compensated liver disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSAGE
Entecavir should be taken orally, on an empty stomach (at least 2
hours after a meal and at least 2 hours before
the next meal).
The recommended oral dose of entecavir in adults and adolescents older
than 16 years is 0.5 mg once daily.
For lamivudine-refractory patients [history of hepatitis B viremia
while receiving lamivudine therapy or
known lamivudine resistance (LVD
R
commonly called YMDD mutations)], the recommended dose is 1 mg
once daily.
RENAL IMPAIRMENT
In patients with renal impairment, the apparent oral clearance of
entecavir decreased as creatinine clearance
decreased (see section 5.1 PHARMACOKINETIC PROPERTIES: Special
Populations). Dosage adjustment
of entecavir is recommended for patients with creatinine clearance <50
mL/min, including patients on
haemodialysis or