SCILIN R

Ország: Indonézia

Nyelv: indonéz

Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktív összetevők:

HUMAN INSULIN

Beszerezhető a:

DEXA MEDICA - Indonesia

INN (nemzetközi neve):

HUMAN INSULIN

Adagolás:

100 IU

Gyógyszerészeti forma:

INJEKSI

db csomag:

DUS, 5 CARTRIDGES @ 3 ML

Gyártó:

BIOTON S.A. - Poland

Engedély dátuma:

2020-03-02

Termékjellemzők

SEBIVO
TM
(Telbivudine)
600 mg tablets
NAME OF THE MEDICINAL PRODUCT
SEBIVO
TM
600 mg film-coated tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg telbivudine
For excipients, see section List of excipients
PHARMACEUTICAL FORM
Film-coated tablet.
While to slightly yellowish-coloured, ovaloid-shaped, film-coated
tablet, imprinted with “LDT” on
one side.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Sebivo is indicated for the treatment of chronic hepatitis B in
patients with evidence of viral
replication and active liver inflammation.
This indications is based on virological, serological, biochemical and
histological responses after
one year of treatment in adult patients with HBeAg-positive and
HBeAg-negative chronic
hepatitis B.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of Sebivo for the treatment of chronic hepatitis
B is 600 mg once daily,
taken orally, with or without food.
The optimal treatment duration has not been established.
RENAL IMPAIRMENT/INSUFFICIENCY
Sebivo may be used for the treatment of chronic hepatitis B in
patients with impaired renal
function. No adjustment of the recommended dose of telbivudine is
necessary in patients whose
creatinine clearance is = 50 mL/min. Adjustment of the dose interval
is required in patients with
creatinine clearance < 50 mL/min including those with end stage renal
disease (ESRD) on
haemodialysis, as shown below (see Table 1). The recommended dose (600
mg) was not
studied in these patients. The recommended change in the dosage
interval is based on
extrapolation of data from patients with varying degrees of renal
impairment, including ESRD.
The safety and efficacy of the dose-interval-adjustment guidelines has
not yet been clinically
tested. It is necessary to ensure close monitoring of efficacy and
safety patients with renal
insufficiency.
TABLE 1 DOSE INTERVAL ADJUSTMENT OF SEBIVO IN PATIENTS WITH RENAL
IMPAIRMENT
CREATININE CLEARANCE (ML/MIN)
DOSE OF SEBIVO
≥50
600 mg once daily
30-49
600 mg once