Sebivo

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Telbivudine

Disponible depuis:

Novartis Pharmaceuticals Australia Pty Ltd

classe:

Medicine Registered

Notice patient

SEBIVO
®

_Telbivudine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sebivo. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. Some more recent
information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SEBIVO IS USED
FOR
Sebivo belongs to a group of
medicines called antivirals.
Sebivo is used to treat chronic
hepatitis B in patients. 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 multiplication, resulting
in less liver damage and
improvement in liver function.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is only available with
a doctor's prescription. It is not
addictive.
Sebivo does not reduce the risk of
infecting others with hepatitis B virus
(HBV) through sexual contact or
exposure to contaminated blood or
other body fluids. You should use
appropriate precautions.
BEFORE YOU TAKE
SEBIVO
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SEBIVO IF:
•
YOU ARE ALLERGIC (HYPERSENSITIVE)
TO TELBIVUDINE (ACTIVE
INGREDIENT) OR TO ANY OF THE

Résumé des caractéristiques du produit

 
1 
SEBIVO


(telbivudine) 

NAME OF THE MEDICINE 

The active ingredient of SEBIVO

  is  telbivudine.  The chemical name is:  1-((2S,4R,5S)-4-
hydroxy-5-hydroxymethyltetrahydrofuran-2-y1)-5-methyl-1H-pyrimidine-2,4-dione or 1-(2-
Deoxy-
β-L-ribofuranosyl)-5-methyluracil; β-L-2′-Deoxythymidine  
(INN/USAN= telbivudine). 
Telbivudine is the unmodified 
β-L enantiomer of naturally-occurring thymidine. 
Alternative name: L-thymidine 
The chemical structure of telbivudine (CAS number 3424-98-4) is: 

HN
N
O
OH
OH
O
O
CH
3

DESCRIPTION 

SEBIVO

 is available as coated
tablets containing 600 mg telbivudine and as oral solution* 
containing 20mg telbivudine per millilitre. 

SEBIVO

 (telbivudine) 600
mg film-coated tablets contain the following inactive ingredients: 
colloidal silicon dioxide, magnesium stearate,
microcrystalline cellulose, povidone, and 
sodium starch glycolate. The tablet coating contains titanium
dioxide, polyethylene glycol, talc 
and hypromellose. 

SEBIVO

 (telbivudine) 20mg/mL oral solution* contain
the following inactive ingredients: 
citric acid anhydrous, benzoic acid, passion fruit flavouring,
sodium saccharin, sodium 
hydroxide and purified water.   

2 
PHARMACOLOGY 

PHARMACOTHERAPEUTIC GROUP:  Antiviral for systemic use. 

PHARMACODYNAMICS 
Telbivudine is a synthetic thymidine nucleoside analogue with activity against
HBV DNA 
polymerase. It is efficiently phosphorylated by cellular kinases to
the active triphosphate form, 
which has an intracellular half-life of 14
hours  in human hepatocarcinoma cell line HepG2. 
Telbivudine-5'-triphosphate
inhibits HBV DNA polymerase (reverse transcriptase)  and thus 
HBV replication. This inhibition is thought to
involve competition with the natural substrate 
thymidine 5'-triphosphate  and incorporation of telbivudine into