Darunavir Zentiva 800 mg, filmomhulde tabletten

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

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

Thành phần hoạt chất:

DARUNAVIR 800 mg/stuk

Sẵn có từ:

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

Mã ATC:

J05AE10

INN (Tên quốc tế):

DARUNAVIR 800 mg/stuk

Dạng dược phẩm:

Filmomhulde tablet

Thành phần:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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), 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),

Tuyến hành chính:

Oraal gebruik

Khu trị liệu:

Darunavir

Tóm tắt sản phẩm:

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);

Ngày ủy quyền:

2017-04-12

Tờ rơi thông tin

Darunavir_400 mg_800 mg_fct_EN_NL-H-3607-001_003_ EPAR 082022-122022 +
name change
2023_02
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR ZENTIVA 400 MG, FILMOMHULDE TABLETTEN
DARUNAVIR ZENTIVA 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 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?
The Darunavir Zentiva 400 mg/800 mg
tablet is used to treat adults and children (3 years of age and
above, at least 40 kilogram (kg) 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).
Darunavir Zentiva must be taken in combination with a low dose of
cobicistat or ritonavir and other
anti-HIV medicines. Your doc

Đặc tính sản phẩm

Darunavir_400 mg_800 mg_fct_EN_NL-H-3607-001_003_ EPAR 082022-122022 +
name change
2023_02
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDELNAME OF THE MEDICINAL PRODUCT
Darunavir Zentiva 400 mg, filmomhulde tabletten
Darunavir Zentiva 800 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir Zentiva 400 mg film-coated tablets:
Each film-coated tablet contains 400 mg of darunavir.
Excipient with known effect:
Each tablet contains 0.258 mg sunset yellow FCF (E110).
Darunavir Zentiva 800 mg film-coated tablets:
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.
Darunavir Zentiva 400 mg film-coated tablets:
Light orange oval shaped film-coated tablet, debossed with ‘400’
on one side and plain on the other
side, with dimensions of approximately 17.1 mm x 8.6 mm.
Darunavir Zentiva 800 mg film-coated tablets:
Dark red oval shaped film-coated tablets, debossed with ‘800’ on
one side and plain on the other side,
with dimensions of approximately 20.2 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.
Darunavir Zentiva, co-administered with cobicistat is indicated in
combination with other
antiretroviral medicinal products for the treatment of human
immunodeficiency virus (HIV-1)
infection in adults and adolescents (aged 12 years and older, weighing
at least 40 kg) (see section 4.2).
Darunavir Zentiva 400 mg and 800 mg 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 plas