Sebivo Tablet 600mg

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

Telbivudine

Boleh didapati daripada:

NOVARTIS (SINGAPORE) PTE LTD

Kod ATC:

Pending

Dos:

600.0mg

Borang farmaseutikal:

TABLET, FILM COATED

Komposisi:

Telbivudine 600.0mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

Novartis Pharma Stein AG

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2007-06-22

Risalah maklumat

 
S
EBIVO™  

Antiviral for systemic use  

COMPOSITION AND PHARMACEUTICAL FORM 

Each film-coated tablet contains 600 mg telbivudine.  

For a full list of excipients, see section EXCIPIENTS.  

White to slightly  yellowish-coloured, ovaloid-shaped, film-coated tablet, imprinted with “LDT” 
on one side; in a blister pack of 28 tablets.  

INDICATIONS  

Sebivo is indicated for the treatment of HBeAg-positive and HBeAg-negative chronic hepatitis B 
in  patients  who  have  compensated  liver  disease,  evidence  of  viral  replication  and  active  liver 
inflammation and who are nucleoside analogue naïve.  
The following points should be considered when
initiating therapy with Sebivo:  

  For HBeAg-positive patients, Sebivo treatment should
only be initiated in patients with 
baseline HBV DNA < 9 log
10
 copies/mL and baseline ALT ≥ 2x ULN. 

  For HBeAg-negative patients, Sebivo treatment should
only be initiated in patients with 
baseline HBV DNA < 7 log
10
 copies/mL. 

DOSAGE AND ADMINISTRATION  

ADULTS  

The recommended dose of Sebivo is 600 mg once daily, taken
orally, with or without food.  
Due  to  risk  of  higher  rates  of  resistance  that  may  develop  with  longer  term  treatment  among 
patients with incomplete viral suppression, treatment should only be initiated after baseline HBV 
DNA criteria are met (see section INDICATIONS).   
MONITORING AND DURATION OF TREATMENT 
On-treatment response at week 24 has been shown to be predictive of longer-term response (see 
section  PHARMACODYNAMICS).  HBV  DNA  levels  should  be  monitored  at  24  weeks  of 
treatment  to  assure  complete  viral  suppression  (HBV  DNA  less  than  300  copies/mL).  For 
patients with detectable HBV DNA after 24 weeks of 

Ciri produk

SEBIVO™
Antiviral for systemic use
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
White to slightly yellowish, ovaloid, slightly curved film-coated
tablet with beveled edges;
imprinted (debossed) with “LDT” on one side; in a blister pack of
28 tablets.
ACTIVE SUBSTANCE
Telbivudine
Each film-coated tablet contains 600 mg telbivudine.
EXCIPIENTS
TABLET CORE: cellulose microcrystalline; povidone; sodium starch
glycolate; magnesium stearate;
silica, colloidal anhydrous.
TABLET FILM COAT: titanium dioxide (E171); macrogol; talc;
hypromellose.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Sebivo is indicated for the treatment of HBeAg-positive and
HBeAg-negative chronic hepatitis B in
patients who have compensated liver disease, evidence of viral
replication and active liver inflammation
and who are nucleoside analogue naïve.
The following points should be considered when initiating therapy with
Sebivo:

For HBeAg-positive patients, Sebivo treatment should only be initiated
in patients with
baseline HBV DNA < 9 log
10
copies/mL and baseline ALT ≥ 2x ULN.

For HBeAg-negative patients, Sebivo treatment should only be initiated
in patients with
baseline HBV DNA < 7 log
10
copies/mL.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
ADULTS
The recommended dose of Sebivo is 600 mg once daily.
Due to risk of higher rates of resistance that may develop with longer
term treatment among patients
with incomplete viral suppression, treatment should only be initiated
after baseline HBV DNA criteria
are met (see section INDICATIONS).
MONITORING AND DURATION OF TREATMENT
On-treatment response at week 24 has been shown to be predictive of
longer-term response (see section
CLINICAL STUDIES). HBV DNA levels should be monitored at 24 weeks of
treatment to ensure
complete viral suppression (HBV DNA less than 300 copies/mL). For
patients with detectable
HBV DNA after 24 weeks of therapy, treatment modifications should be
considered.
HBV DNA should be monitored every 6
months
to ensure continued respons