COPEGUS TABLET 200 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

RIBAVIRIN

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

J05AB04

Dosage:

200 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

RIBAVIRIN 200 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Patheon Inc.

Authorization status:

ACTIVE

Authorization date:

2003-10-13

Patient Information leaflet

Copegus  

Product Information FE 
______________________________________________________________________________________ 

1

COPEGUS
®

Ribavirin 

DIRECT ACTING ANTIVIRAL 

1. 
P
HARMACEUTICAL 
F
ORM

Supplied as a 200mg film-coated tablet for oral administration. 
Light pink, oval-shaped film-coated tablets (marked with RIB 200 on
one side and ROCHE on the 
opposite side). 

2. 
Q
UALITATIVE AND 
Q
UANTITATIVE 
C
OMPOSITION

_Active ingredient:_ Ribavirin. 

3. 
C
LINICAL 
P
ARTICULARS

3.1 
THERAPEUTIC INDICATIONS 
The  combination  of  Copegus  with  peginterferon  alfa  2a  or  interferon  alfa  2a  is  indicated  in  adult 
patients  with  elevated  transaminase  who  are  positive  for  serum  HCV  RNA,  including  patients  with 
compensated  cirrhosis.  The  combination  of  Copegus  with  peginterferon  alfa  2a  is  also  indicated  in 
adult patients without elevated transaminase who are positive for serum HCV RNA, including patients 
with compensated cirrhosis

(see section 3.4).

The  combination  with  peginterferon  alfa  2a  is  also  indicated  in  patients  with  HIV  disease  that  is 
clinically  stable  (e.g.  antiretroviral  therapy  not  required  or  receiving  stable  antiretroviral  therapy), 
including  patients  with  compensated  cirrhosis  (see  section  3.3)
. 
The  combination  regimens  are 
indicated  in  previously  untreated  patients  as  well  as  in  patients  who  have  previously  responded  to 
interferon alpha therapy and subsequently relapsed after treatment
was stopped.  

Copegus is indicated for the treatment of chronic hepatitis C and
must only be used as part of a 
combination regimen with peginterferon alfa-2a or with interferon
alfa-2a. Copegus monotherapy must 
not be used

Summary of Product characteristics

1
COPEGUS
®
Ribavirin
DIRECT ACTING ANTIVIRAL
1.
P
HARMACEUTICAL
F
ORM
Supplied as a 200mg film-coated tablet for oral administration.
Light pink, oval-shaped film-coated tablets (marked with RIB 200 on
one
side and ROCHE on the opposite side).
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
_Active ingredient:_ Ribavirin.
3.
C
LINICAL
P
ARTICULARS
3.1
THERAPEUTIC INDICATIONS
The combination of Copegus with peginterferon alfa 2a or interferon
alfa
2a
is
indicated
in
adult
patients
with
elevated
transaminase
who
are
positive
for
serum
HCV
RNA,
including
patients
with
compensated
cirrhosis. The combination of Copegus with peginterferon alfa 2a is
also
indicated in adult patients without elevated transaminase who are
positive
for serum HCV RNA, including patients with compensated cirrhosis (see
section 3.4).
The combination with peginterferon alfa 2a is also indicated in
patients
with HIV disease that is clinically stable (e.g. antiretroviral
therapy not
required or receiving stable antiretroviral therapy), including
patients with
compensated cirrhosis (see section 3.3). The combination regimens are
indicated in previously untreated patients as well as in patients who
have
previously responded to interferon alpha therapy and subsequently
relapsed
after treatment was stopped.
Copegus is indicated for the treatment of chronic hepatitis C and must
only
be used as part of a combination regimen with peginterferon alfa-2a or
with
interferon alfa-2a. Copegus monotherapy must not be used.
Please refer to the package insert of interferon alfa 2a or
peginterferon alfa
2a products for additional information.
3.2
DOSAGE AND METHOD OF ADMINISTRATION
3.2.1
STANDARD DOSAGE
Copegus film-coated tablets are administered orally in two divided
doses
with food (morning and evening), in combination with interferon alfa
and
peginterferon alfa solution for injection.
The exact dose and duration of treatment depend on the interferon
product
used.
_Posology in combination with peginterferon alfa-2a: _
_Dose to be administered_
The recommende