Darunavir DOC Generic, 800 mg, filmomhulde tabletten

Страна: Нідерланди

мова: голландська

Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активний інгредієнт:

DARUNAVIR

Доступна з:

DOC Generici S.r.l.

Код атс:

J05AE10

ІПН (Міжнародна Ім'я):

DARUNAVIR

Фармацевтична форма:

Filmomhulde tablet

Склад:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Адміністрація маршрут:

Oraal gebruik

Терапевтична области:

Darunavir

Огляд продуктів:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE ROOD (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Дата Авторизація:

2017-05-18

інформаційний буклет

_July 2018: proposed var. 01 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR DOC GENERICI 400 MG, FILMOMHULDE TABLETTEN
DARUNAVIR DOC GENERICI 800 MG, FILMOMHULDE TABLETTEN
darunavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Darunavir DOC Generici is and what it is used for
2.
What you need to know before you take Darunavir DOC Generici
3.
How to take Darunavir DOC Generici
4.
Possible side effects
5.
How to store Darunavir DOC Generici
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR DOC GENERICI IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR DOC GENERICI?
Darunavir
DOC
Generici
contains
the
active
substance
darunavir.
Darunavir
DOC
Generici
is
an
antiretroviral medicine used in the treatment of Human
Immunodeficiency Virus (HIV) infection. It
belongs to a group of medicines called protease inhibitors. Darunavir
DOC Generici works by
reducing
the amount of HIV in your body. This will improve your immune system
and reduces the risk
of
developing illnesses linked to HIV infection.
WHAT IT IS USED FOR?
Darunavir DOC Generici 400 mg/800mg is used to treat adults and
children (3 years of age and above, at
least 40 kg body weight) who are infected by HIV and
-
who have not used antiretroviral medicines before.
-
in certain patients who have used antiretroviral medicines before
(your doctor will determine
this).
Darunavir DOC Generici must be taken in combination with a low dose of
cobicistat or ritonavir and
other anti-HIV medicines. Your doctor will discuss wit

Характеристики продукта

1
_July 2018: proposed var. 01 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir DOC Generici 400 mg, filmomhulde tabletten Darunavir DOC
Generici 800 mg, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of darunavir. Each film-coated
tablet contains 800 mg of darunavir.
Excipient with known effect:
Darunavir DOC Generici 400 mg: Each tablet contains 0.258 mg sunset
yellow FCF (E110). For the full list
of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Darunavir DOC Generici 400 mg: Light orange oval shaped film-coated
tablet, debossed with
‘400’ on
one side and plain on the other side, with dimensions of approximately
17.1 mm x 8.6 mm.
Darunavir DOC Generici 800 mg: Dark red oval shaped film-coated
tablets, debossed with ‘800’ on one
side and plain on the other side, with dimensions of approximately
20.2 mm x 10.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Darunavir DOC Generici, co-administered with low dose ritonavir is
indicated in combination
with
other antiretroviral medicinal products for the treatment of patients
with human immunodeficiency virus
(HIV-1) infection.
Darunavir
DOC
Generici,
co-administered
with
cobicistat
is
indicated
in
combination
with
other
antiretroviral medicinal products for the treatment of human
immunodeficiency virus (HIV-1) infection
in adult patients (see section 4.2).
Darunavir DOC Generici 400mg/800 mg tablets may be used to provide
suitable dose regimens
for the
treatment of HIV-1 infection in adult and paediatric patients from the
age of 3 years and at least 40 kg body
weight who are:
●
antiretroviral therapy (ART)-naïve (see section 4.2).
●
ART-experienced with no darunavir resistance associated mutations
(DRV-RAMs) and
who
have
plasma
HIV-1
RNA
< 100,000 copies/ml
and
CD4+
cell
count
≥ 100 cells x 10
6
/l. In deciding to initiate treatment with Darunavir DOC Generici in
such ART-
experienced patients, genotypic testing should guide the u