Darunavir Sandoz 600 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DARUNAVIR

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

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) ; 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:

2017-05-18

Bijsluiter

Sandoz B.V.
Page 1/13
Darunavir Sandoz 75 mg, 600mg, filmomhulde tabletten
RVG 118531, 118532
1313-V6
1.3.1.3 Bijsluiter
Februari 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARUNAVIR SANDOZ 75 MG, FILMOMHULDE TABLETTEN
DARUNAVIR SANDOZ 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.
k
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 of 3
years of age and above,
and at least 15 kilogram body weight who are infected by HIV and who
have already used
other antiretroviral medicines.
[Nationally completed name] must be taken in combination with a low
dose of ritonavir and
other anti-HIV medici

Productkenmerken

Sandoz B.V.
Page 1/50
Darunavir Sandoz 75 mg, 600 mg, filmomhulde
tabletten
RVG 118531, 118532
1311-V7
1.3.1.1 Samenvatting van de
Productkenmerken
Februari 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir Sandoz 75 mg, filmomhulde tabletten
Darunavir Sandoz 600 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of darunavir.
Each film-coated tablet contains 150 mg of darunavir.
Each film-coated tablet contains 300 mg of darunavir.
Excipient with known effect
Each film-coated tablet contains 1.296 mg of sunset yellow FCF (E
110).
Each film-coated tablet contains 600 mg of darunavir.
Excipient with known effect
Each film-coated tablet contains 2.592 mg of sunset yellow FCF (E
110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_75 mg film-coated tablets _
White, caplet shaped film-coated tablet, debossed with ‘75’ on one
side and plain on the other
side.
Dimensions: approximately 8.6 mm x 4.6 mm
_150 mg film-coated tablets _
White, oval shaped film-coated tablet, debossed with ‘150’ on one
side and plain on the other
side.
Dimensions: approximately 11.1 mm x 5.6 mm
_300 mg film-coated tablets _
Orange, oval shaped film-coated tablet, debossed with ‘300’ on one
side and plain on the
other side.
Dimensions: approximately 15.1 mm x 7.6 mm
_600 mg film-coated tablets _
Orange oval shaped film-coated tablet, debossed with ‘600’ on one
side and plain on the other
side.
Dimensions: approximately 20.1 mm x 10.1 mm
Sandoz B.V.
Page 2/50
Darunavir Sandoz 75 mg, 600 mg, filmomhulde
tabletten
RVG 118531, 118532
1311-V7
1.3.1.1 Samenvatting van de
Productkenmerken
Februari 2023
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 (see section 4.2).
[Nation