EDURANT FILM-COATED TABLET 25 MG

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Rilpivirine hydrochloride 27.50 mg eqv Rilpivirine

Предлага се от:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

АТС код:

J05AG05

дозиране:

25 mg

Лекарствена форма:

TABLET, FILM COATED

Композиция:

Rilpivirine hydrochloride 27.50 mg eqv Rilpivirine 25 mg

Начин на приложение:

ORAL

Вид предписание :

Prescription Only

Произведено от:

Janssen-Cilag S.p.A

Статус Оторизация:

ACTIVE

Дата Оторизация:

2013-06-11

Листовка

 
1

NAME  OF THE MEDICINAL PRODUCT 
EDURANT
®
 25 mg film-coated  tablets 

QUALITATIVE  AND QUANTITATIVE  COMPOSITION 

Each film-coated
tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. 

For a full list of excipients, see _List of Excipients_. 

PHARMACEUTICAL FORM 

White to off-white, film-coated, round, biconvex, tablet of 6.4 mm, debossed with “TMC” on one side 
and “25” on the other side. 

CLINICAL  PARTICULARS  

THERAPEUTIC INDICATIONS 

EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment 
of  human  immunodeficiency  virus  type  1  (HIV-1)  infection  in  antiretroviral  treatment-naïve  adult 
patients  with a viral load ≤ 100,000  HIV-1  RNA copies/mL  at the start of therapy. 

This  indication  is  based  on  safety  and  efficacy  analyses  through  96 weeks  from  2 randomised, 
double-blind,  controlled,  phase III  trials  in  treatment-naïve  patients  (see  _Pharmacodynamic _
_Properties_). 

POSOLOGY  AND METHOD  OF ADMINISTRATION 

EDURANT must always
be given in combination with other antiretroviral medicinal products._ _

Adults_ _
The recommended dose of EDURANT is one 25 mg tablet taken orally  once  daily.  EDURANT  MUST 
BE TAKEN with a meal (see _Pharmacokinetic  Properties_). 

_Dose adjustment _
For  patients  concomitantly  receiving  rifabutin,  the  EDURANT  dose  should  be  increased  to  50 mg 
(two tablets  of  25 mg  each)  once  daily,  taken  with  a  meal.  When  rifabutin  co-administration  is 
stopped,  the  EDURANT  dose  should  be  decreased  to  25 mg  once  daily,  taken  with  a  meal  (see 
_Interaction with Other Medicinal Products and Oth

Данни за продукта

1
PRODUCT NAME
EDURANT
®
(rilpivirine) 25 mg film-coated
tablets
DOSAGE FORMS AND STRENGTHS
White to off-white, film-coated, round, biconvex, tablet of 6.4 mm,
debossed with “TMC” on
one side and “25” on the other side.
Each film-coated tablet contains rilpivirine hydrochloride equivalent
to 25 mg rilpivirine.
For a full list of excipients, see
_List of _
_Excipients_
.
CLINICAL
INFORMATION
INDICATIONS
ADULTS
EDURANT
®
, in combination with other antiretroviral medicinal products, is
indicated for the
treatment of
human immunodeficiency virus type 1
(HIV-1)
infection in
antiretroviral
treatment-naïve
adult
patients with a viral load
≤
100,000 HIV-1 RNA copies/mL at the start
of therapy (see
_Clinical studies_
).
PEDIATRIC PATIENTS (12 TO 17 YEARS OF AGE)
EDURANT
®
, in combination with other antiretroviral medicinal products, is
indicated for the
treatment
of
human
immunodeficiency
virus
type
1
(HIV-1)
infection
in
antiretroviral
treatment-naïve pediatric patients 12 to 17 years with a viral load
of
≤
100000 HIV-1 RNA
copies/mL.
DOSAGE AND
ADMINISTRATION
EDURANT
®
must
always
be
given
in
combination
with
other
antiretroviral
medicinal
products.
_ _
DOSAGE (ADULTS)_ _
The
recommended
dose
of
EDURANT
®
is
one
25 mg
tablet
taken
orally
once
daily.
EDURANT
®
MUST
BE TAKEN
with a meal (see
_Pharmacokinetic _
_Properties_
).
_DOSE ADJUSTMENT WITH RIFABUTIN COADMINISTRATION _
For patients concomitantly receiving rifabutin, the EDURANT
®
dose should be increased to
50 mg
(two tablets
of
25 mg
each)
once
daily,
taken
with
a
meal.
When
rifabutin
co-administration is stopped, the EDURANT
®
dose should be decreased to 25 mg once daily,
taken with a meal (see
_Interaction with Other Medicinal Products and Other Forms of _
_Interaction_
).
SPECIAL POPULATIONS
_PEDIATRICS (12 TO 17 YEARS) _
The recommended dose of EDURANT
®
is one 25 mg tablet once daily taken orally with a
meal (see
_Pharmacokinetic properties_
).
_PEDIATRICS (LESS THAN 12 YEARS OF AGE) _
The safety and efficacy of EDURANT
®
in children