REYATAZ CAPSULE 150 mg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

ATAZANAVIR SULFATE 170.83 mg EQV ATAZANAVIR

Доступно од:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

АТЦ код:

J05AE08

Дозирање:

150 mg

Фармацеутски облик:

CAPSULE

Састав:

ATAZANAVIR SULFATE 170.83 mg EQV ATAZANAVIR 150 mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

AstraZeneca Pharmaceuticals LP

Статус ауторизације:

ACTIVE

Датум одобрења:

2004-03-08

Информативни летак

1 

REYATAZ

(ATAZANAVIR) CAPSULES 
FULL PRESCRIBING INFORMATION 
1 
INDICATIONS AND USAGE 
REYATAZ [atazanavir (as sulfate)] is indicated in combination
with other antiretroviral agents 
for the treatment of HIV-1 infection. This indication is based
on analyses of plasma HIV-1 RNA 
levels and CD4+ cell counts from controlled studies of 96
weeks duration in antiretroviral-naive 
and 48 weeks duration in antiretroviral-treatment-experienced
adult patients, and limited data 
from children aged 6 to less than 18 years. 
The following points should be considered when initiating
therapy with REYATAZ: 
•
  In Study AI424-045 REYATAZ/ritonavir and lopinavir/ritonavir
were similar for the 
primary efficacy outcome measure of time-averaged difference in
change from baseline 
in HIV RNA level. This study was not large enough to reach a
definitive conclusion that 
REYATAZ/ritonavir and lopinavir/ritonavir are equivalent on the
secondary efficacy 
outcome measure of proportions below the HIV RNA
lower limit of detection [see_ _
_Clinical Studies (13.2)_]_._ 
•
  The
number of baseline primary protease inhibitor mutations affects the
virologic 
response to REYATAZ/ritonavir
[see_ Clinical Pharmacology (11.4)_]._ _
2 DOSAGE 
AND 
ADMINISTRATION 
General Dosing Recommendations: 
•
  REYATAZ Capsules must be taken with food. 
•
  Do not open the capsules. 
•
  The recommended oral dosage of REYATAZ depends on the
treatment history of the 
patient and the use of other coadministered drugs
[see _Drug Interactions (7.3)_]. When 
coadministered with H
2
-receptor antagonists or proton-pump inhibitors, dose separation 
may be required [see _Dosage and Administration (2.1)_]. 
•
  When coadministered with didanosine buffered or enteric-coated
formulations, 
REYATAZ should be given (with food) 2 hours before or
1 hour after didanosine. 
•
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Карактеристике производа

1
REYATAZ
®
(ATAZANAVIR) CAPSULES
FULL PRESCRIBING INFORMATION
1
INDICATIONS AND USAGE
REYATAZ [atazanavir (as sulfate)] is indicated in combination with
other antiretroviral agents for
the treatment of HIV-1 infection. This indication is based on analyses
of plasma HIV-1 RNA levels
and CD4+ cell counts from controlled studies of 96 weeks duration in
antiretroviral-naive and 48
weeks duration in antiretroviral-treatment-experienced adult patients,
and limited data from
children aged 6 to less than 18 years.
The following points should be considered when initiating therapy with
REYATAZ:
•
In Study AI424-045 REYATAZ/ritonavir and lopinavir/ritonavir were
similar for the
primary efficacy outcome measure of time-averaged difference in change
from baseline in
HIV RNA level. This study was not large enough to reach a definitive
conclusion that
REYATAZ/ritonavir and lopinavir/ritonavir are equivalent on the
secondary efficacy
outcome measure of proportions below the HIV RNA lower limit of
detection [see
_ Clinical _
_Studies (13.2)_
]
_._
•
The number of baseline primary protease inhibitor mutations affects
the virologic response
to REYATAZ/ritonavir [see
_ Clinical Pharmacology (11.4)_
].
_ _
2
DOSAGE AND ADMINISTRATION
General Dosing Recommendations:
•
REYATAZ Capsules must be taken with food.
•
Do not open the capsules.
•
The recommended oral dosage of REYATAZ depends on the treatment
history of the
patient and the use of other coadministered drugs [see
_Drug Interactions (7.3)_
]. When
coadministered with H
2
-receptor antagonists or proton-pump inhibitors, dose separation
may be required [see
_Dosage and Administration (2.1)_
].
•
When
coadministered
with
didanosine
buffered
or
enteric-coated
formulations,
REYATAZ should be given (with food) 2 hours before or 1 hour after
didanosine.
•
REYATAZ without ritonavir is not recommended for treatment-experienced
adults or
pediatric patients with prior virologic failure [see
_Clinical Studies (13)_
].
2
•
Efficacy and safety of REYATAZ with ritonavir in do