ENTECAVIR SANDOZ entecavir (as monohydrate) 1 mg film-coated tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

entecavir, Quantity: 1 mg

Disponible des:

Sandoz Pty Ltd

Designació comuna internacional (DCI):

Entecavir

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: purified talc; hypromellose; titanium dioxide; lactose monohydrate; crospovidone; magnesium stearate; microcrystalline cellulose; macrogol 6000; iron oxide red; iron oxide yellow

Vía de administración:

Oral

Unidades en paquete:

30 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Entecavir Sandoz is indicated for the treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation. This indication is based on histologic, virologic, biochemical and serological responses in nucleoside-treatment naive and lamividine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.

Resumen del producto:

Visual Identification: Pink, round film coated tablet with debossment on both sides, "SZ", on one side and "109" on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2015-12-10

Informació per a l'usuari

ENTECAVIR SANDOZ
®
1
ENTECAVIR SANDOZ
®
_Entecavir (as monohydrate) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking Entecavir Sandoz. This leaflet
answers some common questions
about Entecavir Sandoz.
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 Entecavir
Sandoz 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 ENTECAVIR
SANDOZ IS USED FOR
Entecavir Sandoz contains entecavir
monohydrate and belongs to a group
of medicines called antiviral
medicines.
Entecavir Sandoz is used to treat
adults infected with hepatitis B virus.
_HOW ENTECAVIR SANDOZ _
_WORKS _
Infection by the hepatitis B virus can
lead to damage to the liver. Entecavir
Sandoz 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 Entecavir
Sandoz is when taken for long
periods.
Your doctor may have prescribed it
for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
ENTECAVIR SANDOZ IS NOT ADDICTIVE.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
Entecavir Sandoz is not
recommended for use in children
under 16 years, as there have been no
studies of its effects in children.
BEFORE YOU TAKE
ENTECAVIR SANDOZ
It is important that you check the
information below before you take
Entecavir Sandoz.
_WHEN YOU MUST NOT TAKE IT _
You must not take Entecavir Sandoz
if you have a history of severe
allergic reactions to Entecavir
Sandoz 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

Fitxa tècnica

200221-Entecavir Sandoz-pi
Page 1 of 25
AUSTRALIAN PRODUCT INFORMATION
ENTECAVIR SANDOZ
® (ENTECAVIR MONOHYDRATE) FILM-COATED
TABLETS
1
NAME OF THE MEDICINE
Entecavir monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
ENTECAVIR
SANDOZ
0.5
mg
film-coated
tablet
contains
0.5
mg
entecavir
(as
monohydrate).
Each
ENTECAVIR
SANDOZ
1
mg
film-coated
tablet
contains
1
mg
entecavir
(as
monohydrate).
_List of excipients with known effect:_
lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ENTECAVIR SANDOZ 0.5 mg film coated tablet – white, round with
debossment on both sides,
“SZ” on one side and “108” on the other side.
ENTECAVIR SANDOZ 1 mg film coated tablet – pink, round with
debossment on both sides,
“SZ” on one side and “109” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
ENTECAVIR SANDOZ is indicated for the treatment of chronic hepatitis B
virus infection in
adults 16 years or older with evidence of active liver inflammation.
This indication is based on histologic, virologic, biochemical and
serological responses in
nucleoside-treatment naive and lamividine-resistant adult patients
with HBeAg-positive or
HBeAg-negative chronic HBV infection with compensated liver disease.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The recommended oral dose of ENTECAVIR SANDOZ in adults and
adolescents older than 16
years is 0.5 mg once daily. For lamivudine-refractory patients
[history of hepatitis B viremia
while receiving lamivudine therapy or known lamivudine resistance (LVD
R
commonly called
YMDD mutations)], the recommended dose is 1 mg once daily (or
alternatively 2 tablets of 0.5
mg once daily).
_Duration of Therapy _
The optimal duration of treatment with entecavir monohydrate for
patients with chronic hepatitis
B infection and the relationship between treatment and long-term
outcomes such as cirrhosis and
hepatocellular carcinoma are unknown.
200221-Entecavir Sandoz-pi
Page 2 of 25
METHOD OF ADMINISTRATION
E