Darunavir STADA 300 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DARUNAVIR 300 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

J05AE10

INN (Algemene Internationale Benaming):

DARUNAVIR 300 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 75 MG, FILMOMHULDE TABLETTEN
DARUNAVIR STADA 150 MG, FILMOMHULDE TABLETTEN
DARUNAVIR STADA 300 MG, FILMOMHULDE TABLETTEN
DARUNAVIR STADA 600 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 is used to treat adults and children of 3 years of age
and above, and at least
15 kg body weight who are infected by HIV and who have already used
other antiretroviral
medicines.
Darunavir STADA 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DARUNAVIR STADA
DO NOT TAKE DARUNAVIR STADA
•
if you are ALLERGIC to dar

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Darunavir STADA 75 mg, filmomhulde tabletten
Darunavir STADA 150 mg, filmomhulde tabletten
Darunavir STADA 300 mg, filmomhulde tabletten
Darunavir STADA 600 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir STADA 75 mg: Each film-coated tablet contains 75 mg of
darunavir.
Darunavir STADA 150 mg: Each film-coated tablet contains 150 mg of
darunavir.
Darunavir STADA 300 mg: Each film-coated tablet contains 300 mg of
darunavir.
Darunavir STADA 600 mg: Each film-coated tablet contains 600 mg of
darunavir.
Excipient with known effect
Darunavir STADA 300 mg: Each tablet contains 1.296 mg sunset yellow
FCF (E110).
Darunavir STADA 600 mg: Each tablet contains 2.592 mg sunset yellow
FCF (E110).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Darunavir STADA 75 mg: White, caplet shaped film-coated tablet,
debossed with ‘75’ on one
side and plain on the other side, with dimensions of approximately 8.6
mm x 4.6 mm.
Darunavir STADA 150 mg: White, oval shaped film-coated tablet,
debossed with ‘150’ on one
side and plain on the other side, with dimensions of approximately
11.1 mm x 5.6 mm.
Darunavir STADA 300 mg: Orange, oval shaped film-coated tablet,
debossed with ‘300’ on
one side and plain on the other side, with dimensions of approximately
15.1 mm x 7.6 mm.
Darunavir STADA 600 mg: Orange oval shaped film coated tablet,
debossed with ‘600’ on one
side and plain on the other side, with dimensions of approximately
20.1 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 (see section 4.2).
Darunavir STADA 75 mg/150 mg/300 mg/600 mg tablets may be used to
provide suitable dose
regimens (see section 4.2):
•
For the treatment of HIV-1 infection in an