Baraclude

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Entecavir monohydrate

Saatavilla:

Bristol-Myers Squibb Australia Pty Ltd

luokka:

Medicine Registered

Pakkausseloste

BARACLUDE
®
 TABLETS

(BARR-AH-KLUDE)
_Entecavir monohydrate (en-TEH-cuh-veer mon-O-HI-drate )_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Baraclude. This leaflet
answers some common questions
about Baraclude.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Baraclude
against the benefits they expect it
will have for you.
If you have any concerns about
taking this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT BARACLUDE IS
USED FOR
Baraclude contains entecavir
monohydrate and belongs to a group
of medicines called antiviral
medicines.
Baraclude is used to treat adults
infected with hepatitis B virus.
_HOW BARACLUDE WORKS_
Infection by the hepatitis B virus can
lead to damage to the liver.
Baraclude reduces the amount of
virus in your body, and has been
shown to improve the condition of
the liver.
It is not known how safe Baraclude is
when taken for long periods.
Your doctor may have prescribed
Baraclude for another reason. Ask
your doctor if you have any questions
about why Baraclude has been
prescribed for you.
BARACLUDE IS NOT ADDICTIVE. THIS
MEDICINE IS AVAILABLE ONLY WITH A
DOCTOR'S PRESCRIPTION.
Baraclude is not recommended for
use in children under 16 years, as
there have been no studies of its
effects in children.
BEFORE YOU TAKE
BARACLUDE
IT IS IMPORTANT THAT YOU CHECK THE
INFORMATION BELOW BEFORE YOU TAKE
BARACLUDE.
_WHEN YOU MUST NOT TAKE_
_BARACLUDE_
You must not take Baraclude if you
have a history of severe allergic
reactions to Baraclude or to any of
the ingredients listed at the end of
this leaflet. Symptoms of a severe
allergic reaction may include; chills,
fever, fast heart beat, wheezing or
coughing, difficulty breathing,
dizziness, flushing, sweating and
swelling of the face, tongue or other
parts of the b

Valmisteyhteenveto

V5.0 10 May 2013 

PRODUCT INFORMATION 

BARACLUDE
TM 
TABLETS AND ORAL SOLUTION 
(entecavir monohydrate) 

NAME OF THE MEDICINE 

Entecavir monohydrate, is a guanosine nucleoside analogue with
selective activity against hepatitis 
B  virus  (HBV).  The  chemical  name  for  entecavir  monohydrate  is  2-amino-1,9-dihydro-9-
[(_1S,3R,4S_)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6_H_-purin-6-one, 
monohydrate. Its molecular formula is C
12
H
15
N
5
O
3

H
2
O, which corresponds to a molecular weight 
of 295.3.  Entecavir monohydrate has the following structural formula: 

1_S_
3_R_
4_S_
H
2
O
N
HN
N
N
H
2
N
O
OH
OH
CH
2

CAS number: 209216-23-9 

DESCRIPTION 

Entecavir  monohydrate  is  a  white  to  off-white  powder.    It  is  slightly  soluble  in  water  (2.4 
mg/mL), and the pH of the saturated solution in water is 7.9 at
25
0


 0.5
0
 C. 
BARACLUDE  film-coated  tablets  are  available  for  oral  administration  in  strengths  of  0.5  mg 
and  1 mg_  _of  entecavir  monohydrate.    BARACLUDE  0.5  mg  and  1  mg  film-coated  tablets 
contain  the  following  inactive  ingredients:  lactose,  microcrystalline  cellulose,  crospovidone, 
povidone,  and  magnesium  stearate.  The    0.5  mg  tablet  coating  contains  titanium  dioxide, 
hypromellose,  Macrogol  400,  polysorbate  80,  and  the  1  mg  tablet  coating  contains  titanium 
dioxide,  hypromellose,  Macrogol  400  and  iron  oxide  red  CI177491.  BARACLUDE  Oral 
Solution  is  available  for  oral  administration  as  a  ready-to-use  solution  containing  0.05  mg  of 
entecavir  monohydrate  per  milliliter.  BARACLUDE  Oral  Solution  contains