Sebivo
País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Folheto informativo - Bula
(PIL)
16-06-2017
Características técnicas
(SPC)
04-07-2017
Ingredientes ativos:
Telbivudine 600mg;
Disponível em:
Novartis New Zealand Ltd
DCI (Denominação Comum Internacional):
Telbivudine 600 mg
Dosagem:
600 mg
Forma farmacêutica:
Film coated tablet
Composição:
Active: Telbivudine 600mg Excipient: Colloidal silicon dioxide Hypromellose Macrogol 4000 Magnesium stearate Microcrystalline cellulose Povidone Purified talc Sodium starch glycolate Titanium dioxide
Unidades em pacote:
Blister pack, PVC/Al x 28 tablets, 28 tablets
Classe:
Prescription
Tipo de prescrição:
Prescription
Fabricado por:
Novartis Pharma Stein AG
Indicações terapêuticas:
Sebivo® is indicated for the treatment of chronic hepatitis B in patients with evidence of viral replication and active liver inflammation. This indication is based on virological, serological, biochemical and histological responses in adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B. The following points should be considered when initiating therapy with Sebivo: 1. For HBeAg-positive patients, Sebivo treatment should only be initiated in patients with baseline HBV DNA 2 x ULN. 2. For HBeAg-negative patients, Sebivo treatment should only be initiated in patients with baseline HBV DNA < 7 log 10 copies/mL
Resumo do produto:
Package - Contents - Shelf Life: Blister pack, PVC/Al - 28 tablets - 36 months from date of manufacture stored at or below 30°C
Data de autorização:
2006-02-20
Folheto informativo - Bula
SEBIVO
®
1
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
O
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Características técnicas
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.0 January 2017
Page 1 of 22
1 PRODUCT NAME
SEBIVO
®
(TELBIVUDINE)
600 mg Film-Coated Tablets
20 mg/mL Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Telbivudine
Each film-coated tablet contains 600 mg telbivudine.
Each mL of oral solution contains 20 mg telbivudine.
3 PHARMACEUTICAL FORM
FILM-COATED TABLET
White to slightly yellowish, ovaloid, slightly curved film-coated
tablet with beveled edges,
imprinted with “LDT” on one side.
ORAL SOLUTION
Clear, colourless to pale yellow, liquid.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sebivo
®
is indicated for the treatment of chronic hepatitis B in patients with
evidence of viral
replication and active liver inflammation.
This indication is based on virological, serological, biochemical and
histological responses in
adult patients with HBeAg-positive and HBeAg-negative chronic
hepatitis B.
The following points should be considered when initiating therapy with
Sebivo:
•
For HBeAg-positive patients, Sebivo treatment should only be initiated
in patients with
baseline HBV DNA < 9 log
10
copies/mL and baseline ALT ≥ 2x ULN.
•
For HBeAg-negative patients, Sebivo treatment should only be initiated
in patients with
baseline HBV DNA < 7 log
10
copies/mL.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of Sebivo for the treatment of chronic hepatitis
B is 600 mg once daily.
Sebivo oral solution may be considered for patients who have
difficulties in swallowing tablets.
Due to risk of higher rates of resistance that may develop with longer
term treatment among
patients with incomplete viral suppression, treatment should only be
initiated after baseline
HBV DNA criteria are met (see section 4.1 Therapeutic indications).
NEW ZEALAND DATA SHEET
New Zealand Data Sheet Template v 1.0 January 2017
Page 2 of 22
MONITORING AND DURATION OF TREATMENT
On-treatment response at week 24 has been shown to be predictive of
longer-term response
(see Pharmacodynamic properties). HBV DNA level
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