Prezista 600mg Film Coated Tablet

Country: Малезија

Језик: Енглески

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

Активни састојак:

DARUNAVIR

Доступно од:

JOHNSON & JOHNSON SDN. BHD.

INN (Међународно име):

DARUNAVIR

Јединице у пакету:

60 Tablets

Произведен од:

JANSSEN ORTHO LLC

Информативни летак

_Consumer Medication Information Leaflet (RiMUP) _
PREZISTA
® FILM COATED TABLET
DARUNAVIR (600MG)
1
WHAT IS IN THIS LEAFLET
1.
What PREZISTA
®
is used for
2.
How PREZISTA
®
works
3.
Before you use PREZISTA
®
4.
How to use PREZISTA
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
PREZISTA
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PREZISTA
® IS USED FOR
PREZISTA is an antiretroviral
medicine. It belongs to a group called
protease inhibitors.
PREZISTA is used to treat adults who
are infected with HIV.
PREZISTA must be taken in
combination with a low dose of
ritonavir and other anti-HIV
medicines.
Your doctor will discuss with you
which combination of medicines is
best for you.
HOW PREZISTA
® WORKS
PREZISTA works by reducing the
amount of Human Immunodeficiency
Virus (HIV) in your body. This will
improve your immune system and
reduces the risk of developing
illnesses linked to HIV infection.
BEFORE YOU USE PREZISTA
®
-
_When you must not use it _
_Do not take PREZISTA: _
-
if you are
ALLERGIC
(hypersensitive) to darunavir,
other ingredients of PREZISTA
or to ritonavir.
Tell your doctor about
ALL
medicines
you take.
DO NOT COMBINE PREZISTA WITH
ANY OF THE FOLLOWING MEDICINES:
-
_astemizole _
or
_terfenadine _
(to treat
allergy symptoms)
-
_midazolam _
or
_triazolam _
(to treat
trouble with sleeping and/or
anxiety)
-
_cisapride _
(to treat some stomach
conditions)
-
_lurasidone _
or
_pimozide _
(to treat
psychiatric conditions)
-
_ergot alkaloids _
(to treat migraine
and headaches)
-
_alfuzosin _
(to treat enlarged
prostate gland)
-
_sildenafil _
(to treat pulmonary
arterial hypertension)
-
_colchicine _
(to treat gout or
familial Mediterranean fever), if
you have renal/hepatic
impairment
-
_lovastatin, simvastatin, or _
_lomitapide _
(to lower cholesterol
levels)
-
_dronedarone, ivabradine, _
_ranolazine (to treat chest pain) _
-
_rifampin _
(to treat some infections
such as tuberculosis)
-
_elbasvir/grazoprevir _
(to treat
hepati

Карактеристике производа

PRODUCT NAME
PREZISTA
®
600 mg Film-Coated Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of darunavir (corresponding to
650.46 mg of darunavir
ethanolate).
For excipients, see
_List of Excipients_
.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange oval-shaped tablet, debossed with 600MG on one side and TMC on
the other side.
CLINICAL INFORMATION
INDICATIONS
PREZISTA (darunavir), co-administered with ritonavir
(PREZISTA/ritonavir), in combination
with other antiretroviral agents, is indicated for the treatment of
human immunodeficiency virus
(HIV) infection in antiretroviral treatment-experienced adult
patients, such as those with HIV–1
strains resistant to more than one protease inhibitor.
The following points should be considered when initiating therapy with
PREZISTA/rtv:
•
The use of other active agents with PREZISTA/rtv is associated with a
greater likelihood of
treatment response
•
The risk and benefits of PREZISTA/rtv have not been established in
treatment-naïve adult
patients or pediatric patients
DOSAGE AND ADMINISTRATION
PREZISTA must always be given with low dose ritonavir as a
pharmacokinetic enhancer and in
combination with other antiretroviral medicinal products. The
prescribing information of ritonavir
must therefore be consulted prior to initiation of therapy with
PREZISTA/rtv.
After therapy with PREZISTA has been initiated, patients should be
advised not to alter the
dosage, dosage form, or discontinue therapy without instruction of
their physician.
_DOSAGE – ADULTS _
The recommended dosage of PREZISTA is 600 mg twice daily (b.i.d.)
taken with ritonavir 100
mg b.i.d. and with food.
The type of food does not affect the exposure to darunavir. Ritonavir
is used as a pharmacokinetic
enhancer of darunavir (see
_Interactions _
and
_ Pharmacokinetic Properties_
).
_Children (less than 12 years of age) and adolescents (12 to 17 years
of age):_
PREZISTA/rtv is
not approved for use in these populations.
PREGNANCY AND POSTPARTUM
No dose adjustment is required