Darunavir Rowex 400 mg Film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Darunavir

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

J05AE; J05AE10

INN (International Name):

Darunavir

Dosering :

400 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Protease inhibitors; darunavir

Autorisasjon status:

Not marketed

Autorisasjon dato:

2017-06-02

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARUNAVIR ROWEX 400 MG FILM-COATED TABLETS
DARUNAVIR ROWEX 800 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.
WHAT IS IN THIS LEAFLET
1.
What Darunavir Rowex is and what it is used for
2.
What you need to know before you take Darunavir Rowex
3.
How to take Darunavir Rowex
4.
Possible side effects
5.
How to store Darunavir Rowex
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR ROWEX IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR ROWEX?
Darunavir Rowex contains the active substance darunavir. Darunavir
Rowex 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 Rowex
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 IS IT USED FOR?
Darunavir Rowex 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).
Darunavir Rowex must be taken in combination with a low dose of
cobicistat or 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 ROWEX
DO NOT TAKE DARUNAVIR

Preparatomtale

Health║Products║Regulatory║Authority
13║September║2019
CRN008V9G
Page║1║of║36
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Darunavir║Rowex║400║mg║Film-coated║tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each║film-coated║tablet║contains║400║mg║darunavir.
Excipient(s) with known effect
Each║tablet║contains║0.258║mg║sunset║yellow║FCF║(E110).║
For║the║full║list║of║excipients,║see║section║6.1.
3 PHARMACEUTICAL FORM
Film-coated║tablet
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
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Darunavir║Rowex,║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║Rowex,║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║(see║section║4.2).
Darunavir║Rowex║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).

●║
║ AR║T║
-║
experienced║ with║ no║ darunavir║ resistance║ associated║
mutations║ (DR║
V║-║RAMs)║ and║ who║ ║
hav║
e║
║ plasm║
a║
║ HI║V║
-║
1║║
RNA║
<║100,000║║
copies/ml║and║CD4║+║cell║count║║
≥║║
100║ cells║ x║
10║
6║
/l.║║In║deciding║to║initiat