Sebivo

Land: Europese Unie

Taal: Engels

Bron: EMA (European Medicines Agency)

Werkstoffen:

telbivudine

Beschikbaar vanaf:

Novartis Europharm Limited

ATC-code:

J05AF11

INN (Algemene Internationale Benaming):

telbivudine

Therapeutische categorie:

Nucleoside and nucleotide reverse transcriptase inhibitors

Therapeutisch gebied:

Hepatitis B, Chronic

therapeutische indicaties:

Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.

Product samenvatting:

Revision: 20

Autorisatie-status:

Withdrawn

Autorisatie datum:

2007-04-24

Bijsluiter

47
B. PACKAGE LEAFLET
Medicinal product no longer authorised
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEBIVO 600 MG FILM-COATED TABLETS
Telbivudine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sebivo is and what it is used for
2.
What you need to know before you take Sebivo
3.
How to take Sebivo
4.
Possible side effects
5.
How to store Sebivo
6.
Contents of the pack and other information
1.
WHAT SEBIVO IS AND WHAT IT IS USED FOR
Sebivo contains the active substance telbivudine. Sebivo belongs to a
group of medicines called
antiviral medicines, which are used to treat infections caused by
viruses.
Sebivo is used to treat adults with chronic hepatitis B. Starting
treatment with Sebivo should only be
considered when it is not possible or appropriate to use an
alternative medicine to which the hepatitis
B virus is less likely to develop resistance. Your doctor will decide
which treatment is most
appropriate for you.
Hepatitis B is caused by infection with the hepatitis B virus, which
multiplies in the liver and causes
liver damage. Treatment with Sebivo reduces the amount of hepatitis B
virus in the body by blocking
its growth, resulting in less liver damage and improved liver
function.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SEBIVO
DO NOT TAKE SEBIVO
-
if you are allergic to telbivudine or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are being treated with pegylated or standard interferon alfa
(see “Taking other
medicines”).
If this applies to you, DO NO

Productkenmerken

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Sebivo 600 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg telbivudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to slightly yellowish, oval film-coated tablet, imprinted with
“LDT” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sebivo is indicated for the treatment of chronic hepatitis B in adult
patients with compensated liver
disease and evidence of viral replication, persistently elevated serum
alanine aminotransferase (ALT)
levels and histological evidence of active inflammation and/or
fibrosis.
Initiation of Sebivo treatment should only be considered when the use
of an alternative antiviral agent
with a higher genetic barrier to resistance is not available or
appropriate.
See section 5.1 for details of the study and specific patient
characteristics on which this indication is
based.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy must be initiated by a physician experienced in the management
of chronic hepatitis B
infection.
Posology
_Adults _
The recommended dose of Sebivo is 600 mg (one tablet) once daily.
Sebivo oral solution may be considered for patients who have
difficulties swallowing tablets.
_Monitoring during treatment _
On-treatment response at week 24 has been shown to be predictive of
longer-term response (see
Table 7 in section 5.1). 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 therapy, treatment modification should be
considered.
HBV DNA should be monitored every 6 months to assure continued
response. If patients test positive
for HBV DNA at any time after their initial response, treatment
modification should be considered.
Optimal therapy should be guided by resistance testing.
Medicinal product no