Darunavir STADA 400 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DARUNAVIR 400 mg/stuk

Beschikbaar vanaf:

Centrafarm B.V. Nieuwe Donk 3 4879 AC ETTEN LEUR

ATC-code:

J05AE10

INN (Algemene Internationale Benaming):

DARUNAVIR 400 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Darunavir

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);

Autorisatie datum:

2017-04-11

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR STADA 400 MG FILMOMHULDE TABLETTEN
DARUNAVIR STADA 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Darunavir STADA is and what it is used for
2. What you need to know before you take Darunavir STADA
3. How to take Darunavir STADA
4. Possible side effects
5. How to store Darunavir STADA
6. Contents of the pack and other information
1. WHAT DARUNAVIR STADA IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR STADA ?
Darunavir
STADA
contains
the
active
substance
darunavir.
Darunavir
STADA
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 STADA 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 STADA 400 mg/800 mg 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 STADA must be taken in combination with a low dose of
cobicistat or ritonavir and
other anti-HIV medicines. Your doctor will discuss with you which
combination of medicines is
best for you.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DARUNAVIR STADA
DO NOT TAKE DARUNAVIR

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Darunavir STADA 400 mg, filmomhulde tabletten
Darunavir STADA 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 STADA 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 STADA 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 STADA 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 STADA, 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 STADA, co-administered with cobicistat is indicated in
combination with other
antiretroviral medicinal products for the treatment of human
immunodeficiency virus (HIV-1)
infection in adults and adolescents (aged 12 years and older, weighing
at least 40 kg) (see
section 4.2).
Darunavir STADA 400 mg and 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 STADA in such
ART-experienced patients,
genotypic testing should guide the use of Darunavir STADA (see
section