Darunavir Sandoz 75 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

DARUNAVIR

Dostopno od:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Koda artikla:

J05AE10

INN (mednarodno ime):

DARUNAVIR

Farmacevtska oblika:

Filmomhulde tablet

Sestava:

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),

Pot uporabe:

Oraal gebruik

Terapevtsko območje:

Darunavir

Povzetek izdelek:

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);

Datum dovoljenje:

2017-05-18

Navodilo za uporabo

Sandoz B.V.
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Darunavir Sandoz 75 mg 600mg, filmomhulde
tabletten
RVG 118534 en 118535
V6
1.3.1.3 Bijsluiter
Februari 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[NATIONALLY COMPLETED NAME] 75 MG FILM-COATED TABLETS
[NATIONALLY COMPLETED NAME] 600 MG FILM-COATED TABLETS
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 ant

Lastnosti izdelka

Sandoz B.V.
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Darunavir Sandoz 75 en 600 mg, filmomhulde tabletten
RVG 118534 en 118535
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.
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
_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
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).
[Nationally completed name] tablets may be used to provide suitable
dose regimens (see
section 4.2):
•
For the treatment of HIV-1 infection in antiretroviral treatment
(ART)-experienced adult
patients, including those that have been highly pre-treated.
•
For the treatment of HIV-1 infection in paediatric patients from the
age of 3 years and at
least 15 kg body weight.
In deciding to initiate treatment with [Nationally completed name]
co-administered with low
Sandoz B.V.
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Darunavir Sandoz 75 en 600 mg, filmomhulde tabletten
RVG 118534 en 118535
V7
1.3.1.1 Samenvatting van de Productkenmerken
Februari 2023
dose ritona