Darunavir Sandoz 800 mg, filmomhulde tabletten

Pays: Pays-Bas

Langue: néerlandais

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

Ingrédients actifs:

DARUNAVIR

Disponible depuis:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Code ATC:

J05AE10

DCI (Dénomination commune internationale):

DARUNAVIR

forme pharmaceutique:

Filmomhulde tablet

Composition:

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),

Mode d'administration:

Oraal gebruik

Domaine thérapeutique:

Darunavir

Descriptif du produit:

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);

Date de l'autorisation:

2017-05-18

Notice patient

Sandoz B.V.
Page 1/12
Darunavir Sandoz
®
800 mg, filmomhulde tabletten
RVG 118533
1313-V9
1.3.1.3 Bijsluiter
Februari 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARUNAVIR SANDOZ 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
WHAT IS [NATIONALLY COMPLETED NAME]?
[Nationally completed name] contains the active substance darunavir.
[Nationally completed
name] is an antiretroviral medicine used in the treatment of Human
Immunodeficiency Virus
(HIV) infection. It belongs to a group of medicines called protease
inhibitors. [Nationally
completed name] 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?
[Nationally completed name] is used to treat adults and children (3
years of age and
above, at least 40 kilograms 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)
[Nationally completed name] must be taken in combination with a low
dose o

Résumé des caractéristiques du produit

Sandoz B.V.
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Darunavir Sandoz 800 mg, filmomhulde tabletten
RVG 118533
1311-V9
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir Sandoz 800 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of darunavir.
Excipient with known effect
Each film-coated tablet contains 0.258 mg of sunset yellow FCF (E
110).
Each film-coated tablet contains 800 mg of darunavir.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_400 mg film-coated tablets _
Light orange oval shaped film-coated tablet, debossed with ‘400’
on one side and plain on the
other side.
Dimensions: approximately 17.1 x 8.6 mm
_800 mg film-coated tablets _
Dark red oval shaped film-coated tablet, debossed with ‘800’ on
one side and plain on the
other side.
Dimensions: approximately 20.2 x 10.1 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name], 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.
[Nationally completed name], 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
and adolescents (aged 12
years and older, weighing at least 40 kg) (see section 4.2).
[Nationally completed name] 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
Sandoz B.V.
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Darunavir Sandoz 800 mg, filmomhulde tabl