SEBIVO telbivudine 600mg tablet blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

Telbivudine

Inapatikana kutoka:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Jina la Kimataifa):

Telbivudine

Taarifa za kipeperushi

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
OTHER INGREDIEN

Tabia za bidhaa

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

-L enantiomer of naturally-occurring thymidine.
Alternative name: L-thymidine
The chemical structure of telbivudine (CAS number 3424-98-4) is:
HN
N
O
O
H
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.
A 600 mg dose (30 mL) of Sebivo oral solution contains approximately
47 mg of sodium.
PHARMACOLOGY
PHARMACOTHERAPEUTIC GROUP:
Antiviral for systemic use.
2
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 viral
DNA, causing DNA
chain termination. Telbivudine is an inhibitor of both HBV
first-strand (EC
50
= 0.4-3.1

M)
and second-strand (EC
50
= 0.12-0.47

M) synthesis, an