Daclavir 60mg Film Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

daclatasvir dihydrochloride

Boleh didapati daripada:

PHARMANIAGA MANUFACTURING BERHAD

INN (Nama Antarabangsa):

daclatasvir dihydrochloride

Unit dalam pakej:

28 Tablets

Dikeluarkan oleh:

European Egyptian for Pharmaceutical Industries Co.

Risalah maklumat

DACLAVIR 60MG FILM COATED TABLET
Daclatasvir (60 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DACLAVIR is used for
2.
How DACLAVIR works
3.
Before using DACLAVIR
4.
How to use DACLAVIR
5.
While you are using it DACLAVIR
6.
Side effects
7.
Storage
and
Disposal
of
DACLAVIR
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT DACLAVIR IS USED FOR
Daclavir contains the active ingredient
daclatasvir. It is used to treat adults with
hepatitis
C,
an
infectious
disease
that
affects the liver, caused by the hepatitis
C virus.
HOW DACLAVIR WORK?
This
medicine
works
by
stopping
the
hepatitis C virus from multiplying and
infecting
new
cells.
This
lowers
the
amount of hepatitis C virus in your body
and removes the virus from your blood
over a period of time.
Daclavir must always be used together
with other medicines against hepatitis C
infection
and
must
never
be
used
by
itself.
BEFORE USING DACLAVIR
_-When you must not use it _
•
if you are allergic to daclatasvir or
any of the other ingredients of this
medicine
•
If
you
are
taking
(by
mouth
or
other
ways
that
affect
the
whole
body)
any
of
the
following
medicines

phenytoin,
carbamazepine,
oxcarbazepine or phenobarbital,
used to treat epileptic seizures.

rifampicin,
rifabutin
or
rifapentine, antibiotics
used
to
treat tuberculosis.

dexamethasone, a steroid used
to
treat
allergic
and
inflammatory diseases.

medicines containing St. John’s
wort (Hypericum perforatum, a
herbal preparation).
These
medicines
lower
the
effect
of
Daclavir
and
may
result
in
your
treatment not working. If you take any of
these
medicines,
tell
your
doctor
immediately.
-Before you start to use it
Talk to your doctor or pharmacist before
taking Daclavir.
Tell your doctor if any of the following
applies:
•
Currently take, or have taken in the
last
few
months,
the
medicine
amiodarone
to
treat
irregular
heartbeats
(your
doctor
may
consider
alternative
treatments
if
you have taken this medicine)
•
I

Ciri produk

1
DACLAVIR 60 MG FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Daclavir 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Daclavir 60 mg film-coated tablets
Each film-coated tablet contains daclatasvir dihydrochloride
equivalent to 60 mg daclatasvir.
Excipient(s) with known effect
Each 60 mg film-coated tablet contains 104 mg of lactose (as
anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Daclavir 60 mg film-coated tablet is a green, round biconvex
film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DACLAVIR is indicated in combination with other medicinal products for
the treatment of chronic
hepatitis
C
(CHC)
in
adults
(see
sections
Recommended
Dose,
Instruction
for
Use,
Warning
and
Precautions and Pharmacodynamics).
For hepatitis C virus (HCV) genotype specific activity, (see sections
Warning and Precautions and
Pharmacodynamics).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Daclavir should be initiated and monitored by a
physician experienced in the management
of chronic hepatitis C.
Posology
The recommended dose of Daclavir is 60 mg once daily, to be taken
orally with or without meals. Daclavir
must be administered in combination with other medicinal products. The
Product Information for the other
medicinal products in the regimen should also be consulted before
initiation of therapy with Daclavir.
Table 1 provides the recommended Daclavir-containing treatment
regimens and duration based on HCV
genotype
and
patient
population.
For
specific
dosage
recommendations
for
sofosbuvir, refer
to
the
prescribing information. The optimal duration of Daclavir and
sofosbuvir with or without ribavirin has not
been established for HCV genotype 3 patients with cirrhosis or for HCV
genotype 1 patients with Child-
Pugh C cirrhosis (see sections 5.1).
TABLE 1: RECOMMENDED TREATMENT FOR DACLAVIR INTERFERON-FREE
COMBINATION THERAPY
PATIENT POPULATION*
REGIMEN AND DURATION
_HCV Genotype 1 _
Without cirrhosis
Child Pugh A cirrhosis
Dacla