MyHep ALL (Sofosbuvir and Velpatasvir Film Coated Tablets 400mg100mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

VELPATASVIR; Sofosbuvir

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

VELPATASVIR; Sofosbuvir

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MYHEP ALL (SOFOSBUVIR AND VELPATASVIR
FILM COATED TABLETS 400MG/100MG)
Sofosbuvir & Velpatasvir (400mg/100mg)
WHAT IS IN THIS LEAFLET
1.
What
_MyHep ALL _
is used for
2.
How it works
3.
Before you use
_MyHep ALL _
4.
How to use
_MyHep ALL _
5.
While you are using it
6.
Side Effects
7.
Storage and disposal of
_MyHep _
_ALL _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT _MYHEP ALL _IS USED FOR
_MyHep _
_ALL _
is
a
medicine
that
contains
the
active
substances
sofosbuvir
and
velpatasvir
in
a
single tablet. It is given to treat a
chronic (long-term) viral infection of
the liver called hepatitis C in adults
of 18 years and older.
HOW MYHEP ALL WORKS
The
active
substances
in
this
medicine work together by blocking
two different proteins that the virus
needs to grow and reproduce itself,
allowing
the
infection
to
be
permanently
eliminated
from
the
body.
_MyHep ALL _
is sometimes taken with
another medicine, ribavirin.
It is very important that you also
read
the
leaflets
for
the
other
medicines that you will be taking
with
_MyHep ALL_
. If you have any
questions
about
your
medicines,
please
ask
your
doctor
or
pharmacist.
BEFORE YOU USE MYHEP ALL_ _
_ _
_When you must not use it _
DO NOT TAKE _MYHEP ALL _
•
If you are allergic to sofosbuvir,
velpatasvir or any of the other
ingredients of this medicine.
•
IF YOU ARE CURRENTLY TAKING ANY
OF THE FOLLOWING MEDICINES:
i.
RIFAMPICIN
and
RIFABUTIN
(antibiotics
used
to
treat
infections,
including
tuberculosis);
ii.
ST.
JOHN’S
WORT
(Hypericum
perforatum – herbal medicine
used to treat depression);
iii.
CARBAMAZEPINE,
PHENOBARBITAL
and
PHENYTOIN
(medicines
used
to
treat
epilepsy and prevent seizures);
_Before _
_you _
_start _
_to _
_use _
_it _
WARNING
AND
PRECAUTIONS
Talk to your doctor if you:
•
HAVE LIVER PROBLEMS
other than
from hepatitis C, for instance
i.
IF
YOU
HAVE
A
CURRENT
OR
PREVIOUS INFECTION WITH THE
HEPATITIS B VIRUS
, since your
doctor

Ciri produk

Sofosbuvir and Velpatasvir Film Coated Tablets
400 mg/100 mg
1. NAME OF THE MEDICINAL PRODUCT
MYHEP ALL (Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100
mg)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH FILM COATED TABLET CONTAINS:
SOFOSBUVIR 400 MG
VELPATASVIR 100 MG
Excipients with known effects: Each film-coated tablet contains 261.0
mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film coated tablet;
Light green to green colored capsule shaped biconvex beveled edge film
coated tablet debossed with ‘S and F on either
side of score line’ on one side and ‘M and V on either side of
Score Line’ on another side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sofosbuvir and Velpatasvir Film Coated Tablets 400 mg/100 mg is
indicated for the treatment of chronic hepatitis
C virus (HCV) infection in adults (see sections Posology & Method of
Administration, Warning & Precautions, and
Pharmacodynamics).
4.2 POSOLOGY
The recommended dose of Sofosbuvir and Velpatasvir Film Coated Tablets
400 mg/100 mg is one tablet, taken orally,
once daily with or without food (see section Pharmacokinetics).
TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES
PATIENT POPULATION
A
TREATMENT AND DURATION
Patients with genotype 1, 2, 3, 4, 5 or 6 HCV
Patients without cirrhosis and patients with
compensated cirrhosis
Sofosbuvir and Velpatasvir Film Coated Tablets
400 mg/100 mg for 12 weeks
Patients with genotype 1 or 3 HCV
PATIENTS WITH DECOMPENSATED CIRRHOSIS
Sofosbuvir and Velpatasvir Film Coated Tablets
400 mg/100 mg + ribavirin
b
for 12 weeks
a.
Includes patients co-infected with human immunodeficiency virus (HIV).
b.
When administered with Sofosbuvir and Velpatasvir Film Coated Tablets
400 mg/100 mg, the recommended
dosage of ribavirin is based on weight (administered with food); 1000
mg per day for patients less than 75kg
and 1200 mg for those weighing at least 75kg, divided and administered
twice daily. The starting dosage and
on-treatment dosage o