Darunavir DOC Generici 150 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DARUNAVIR

Beschikbaar vanaf:

DOC Generici S.r.l.

ATC-code:

J05AE10

INN (Algemene Internationale Benaming):

DARUNAVIR

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),

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);

Autorisatie datum:

2017-05-18

Bijsluiter

1
_July 2018: proposed var. 01 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR DOC GENERICI 75 MG, FILMOMHULDE TABLETTEN
DARUNAVIR DOC GENERICI 150 MG, FILMOMHULDE TABLETTEN
DARUNAVIR DOC GENERICI 300 MG, FILMOMHULDE TABLETTEN
DARUNAVIR DOC GENERICI 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, 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

Lees het volledige document

Productkenmerken

July 2018: proposed var. 01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir DOC Generici 75 mg, filmomhulde tabletten Darunavir DOC
Generici 150 mg, filmomhulde
tabletten Darunavir DOC Generici 300 mg, filmomhulde tabletten
Darunavir DOC Generici 600 mg,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir DOC Generici 75 mg: Each film-coated tablet contains 75 mg
of darunavir. Darunavir DOC
Generici 150 mg: Each film-coated tablet contains 150 mg of darunavir.
Darunavir DOC Generici 300 mg:
Each film-coated tablet contains 300 mg of darunavir. Darunavir DOC
Generici 600 mg: Each film-coated
tablet contains 600 mg of darunavir.
Excipient with known effect:
Darunavir DOC Generici 300 mg: Each tablet contains 1.296 mg sunset
yellow FCF (E110). Darunavir
DOC Generici 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 DOC Generici 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 DOC Generici 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 DOC Generici 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 DOC Generici 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
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 (see section 4.2).
Darunavir DOC Generici 75 mg