Darunavir Zentiva 600 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DARUNAVIR 600 mg/stuk

Beschikbaar vanaf:

Alvogen Malta Operations (ROW) Ltd. Malta Life Sciences Park, Building 1, Level 4, Sir Temi Zammit Buildings SGN 3000 SAN GW

ATC-code:

J05AE10

INN (Algemene Internationale Benaming):

DARUNAVIR 600 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:

2017-04-12

Bijsluiter

Darunavir_600 mg_fct_NL_en_NL-H-3607-002_EPAR 082022-122022+name
change 022023
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR ZENTIVA 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 Zentiva is and what it is used for
2.
What you need to know before you take Darunavir Zentiva
3.
How to take Darunavir Zentiva
4.
Possible side effects
5.
How to store Darunavir Zentiva
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR ZENTIVA IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR ZENTIVA?
Darunavir Zentiva contains the active substance darunavir. Darunavir
Zentiva 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 Zentiva 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 Zentiva is used to treat adults and children of 3 years of
age and above, and at least
15 kilogram (kg) body weight who are infected by HIV and who have
already used other antiretroviral
medicines.
Darunavir Zentiva 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 ZENTIVA
DO NOT TAKE DARUNAVIR ZENTIVA
-
if you are
ALLERGIC
to darunavir

Productkenmerken

Darunavir_600 mg_fct_NL_en_NL-H-3607-002_EPAR 082022-122022+name
change 022023
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Darunavir Zentiva 600 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of darunavir.
Excipient with known effect
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.
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 Zentiva 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 Zentiva 600 mg 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 Darunavir Zentiva
co-administered with low dose ritonavir,
careful consideration should be given to the treatment history of the
individual patient and the patterns
of mutations associated with different agents. Genotypic or phenotypic
testing (when available) and
treatment history should guide the use of Darunavir Zentiva (see
sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a healthcare provider experienced in
the management of HIV infection.
After therapy with Darunavir Zentiva has been initiated, patients
should be advised not to alter the
dosage, dose form or discontinue therapy without discussing with their
healthcare provider.
Posology
Darunavir Zentiva must alway