PREZISTA™ TABLET 800MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Darunavir Ethanolate 867.28mg eqv Darunavir

Available from:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

ATC code:

J05AE10

Dosage:

800 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Darunavir Ethanolate 867.28mg eqv Darunavir 800 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

JANSSEN-ORTHO LLC

Authorization status:

ACTIVE

Authorization date:

2014-08-28

Patient Information leaflet

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) infection.
PAEDIATRIC PATIENTS
PREZISTA, in combination with low dose ritonavir (PREZISTA/rtv) and
with other antiretroviral agents, is indicated for the treatment of
human immunodeficiency virus (HIV) infection in
treatment‑experienced paediatric patients of 6 years and above and
at least 20kg body weight.
In treatment-experienced adult and paediatric patients, the following
points should be considered

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