Darunavir Rowex 800 mg Film-coated tablets

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Darunavir

Fáanlegur frá:

Rowex Ltd

ATC númer:

J05AE; J05AE10

INN (Alþjóðlegt nafn):

Darunavir

Skammtar:

800 milligram(s)

Lyfjaform:

Film-coated tablet

Gerð lyfseðils:

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

Lækningarsvæði:

Protease inhibitors; darunavir

Leyfisstaða:

Marketed

Leyfisdagur:

2017-06-02

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 ROWEX
-
if you are
ALLERGIC
to darunavir o

Vara einkenni

HealthProductsRegulatoryAuthority
22June2023
CRN00DFH5
Page1of37
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DarunavirRowex800mgFilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Darkredovalshapedfilm-coatedtablet,debossedwith‘800’ononesideandplainontheotherside.
Dimensions:approximately20.2x10.1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andadolescents(aged12yearsandolder,
weighingatleast40kg)(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).

ART-experiencedwithnodarunavirresistanceassociatedmutations(DRV-RAMs)andwhohaveplasmaHIV-1RNA
<100,000copies/mlandCD4+cellcount≥100cellsx106/l.IndecidingtoinitiatetreatmentwithDarunavir
RowexinsuchART-experiencedpatients,�