PREZISTA™ TABLET 600MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DARUNAVIR ETHANOLATE 650.46 mg EQV DARUNAVIR; Darunavir Ethanolate eqv Darunavir

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

J05AE10

Dosage:

600mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

DARUNAVIR ETHANOLATE 650.46 mg EQV DARUNAVIR 600mg; Darunavir Ethanolate eqv Darunavir 600mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

JANSSEN-ORTHO LLC

Authorization status:

ACTIVE

Authorization date:

2010-08-26

Patient Information leaflet

- 1 -

PRODUCT NAME 
PREZISTA
®
 75 mg film-coated tablets. 
PREZISTA
®
 150 mg film-coated tablets. 
PREZISTA
®
 400 mg film-coated tablets. 
PREZISTA
®
 600 mg film-coated tablets. 
PREZISTA
®
 800mg film-coated tablets. 

PHARMACEUTICAL FORM 
Film-coated tablet. 
-  75mg white caplet-shaped tablet, debossed with 75 on one side and TMC on the other side; contains 
75 mg of darunavir (corresponding to 81.31 mg of
darunavir ethanolate). 
-  150mg white oval-shaped tablet, debossed with 150 on one side and TMC on the other side; contains 
150 mg of darunavir (corresponding to 162.62 mg of
darunavir ethanolate). 
-  400mg  light  orange  oval-shaped  tablet,  debossed  with  400MG  on  one  side  and  TMC  on  the  other 
side;  contains  400 mg  of  darunavir  (corresponding  to  433.64  mg  of  darunavir  ethanolate).  The 
film-coating of
the light orange tablet contains sunset yellow FCF (E110). 
-  600mg  orange  oval-shaped  tablet,  debossed  with  600MG  on  one  side  and  TMC  on  the  other  side; 
contains  600 mg  of  darunavir  (corresponding  to  650.46  mg  of  darunavir  ethanolate).  The 
film-coating of the orange tablet contains sunset yellow
FCF (E110). 
-  800mg dark red oval-shaped tablet, debossed with 800 on one side and T on the other side; contains 
800mg  of  darunavir  (corresponding  to  867.28mg  of  darunavir  ethanolate).  The  film  coating  of  the 
dark red tablet contains Iron Oxide Red. 
For excipients, see _List of Excipients_. 

CLINICAL INFORMATION 
INDICATIONS 
ADULT PATIENTS 
PREZISTA,  in  combination  with  100 mg  low  dose  ritonavir  (PREZISTA/rtv)  and  with  other 
antiretroviral agents, is indicated for the treatment of human
immunodeficiency virus (HIV) infe

Summary of Product characteristics

- 1 -
PRODUCT NAME
PREZISTA
®
75 mg film-coated tablets.
PREZISTA
®
150 mg film-coated tablets.
PREZISTA
®
400 mg film-coated tablets.
PREZISTA
®
600 mg film-coated tablets.
PREZISTA
®
800mg film-coated tablets.
DOSAGE FORMS AND STRENGTHS
Film-coated tablet
-
75mg white caplet-shaped tablet, debossed with 75 on one side and TMC
on the other side; contains
75 mg of darunavir (corresponding to 81.31 mg of darunavir
ethanolate).
-
150mg white oval-shaped tablet, debossed with 150 on one side and TMC
on the other side; contains
150 mg of darunavir (corresponding to 162.62 mg of darunavir
ethanolate).
-
400mg light orange oval-shaped tablet, debossed with 400MG on one side
and TMC on the other
side; contains 400 mg of darunavir (corresponding to 433.64 mg of
darunavir ethanolate). The
film-coating of the light orange tablet contains sunset yellow FCF
(E110).
-
600mg orange oval-shaped tablet, debossed with 600MG on one side and
TMC on the other side;
contains
600 mg
of
darunavir
(corresponding
to
650.46
mg
of
darunavir
ethanolate).
The
film-coating of the orange tablet contains sunset yellow FCF (E110).
-
800mg dark red oval-shaped tablet, debossed with 800 on one side and T
on the other side; contains
800mg of darunavir (corresponding to 867.28mg of darunavir
ethanolate). The film coating of the
dark red tablet contains Iron Oxide Red.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
ADULT PATIENTS
PREZISTA
®
,
in
combination
with
100 mg
low
dose
ritonavir
(PREZISTA
®
/rtv)
and
with
other
antiretroviral agents, is indicated for the treatment of human
immunodeficiency virus (HIV) infection.
PEDIATRIC PATIENTS
PREZISTA
®
, in combination with low dose ritonavir (PREZISTA
®
/rtv) and with other antiretroviral
agents, is indicated for the treatment of HIV infection in
treatment-experienced pediatric patients of
6 years and above and at least 20kg body weight.
In treatment-experienced adult and pediatric patients, the following
points should be considered when
initiating therapy with PR