Darunavir Teva Tablet, film coated 400mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

DARUNAVIR

Tilgjengelig fra:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC-kode:

J05AE10

INN (International Name):

DARUNAVIR 400 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

DARUNAVIR 400 mg

Resept typen:

POM

Terapeutisk område:

ANTIVIRALS FOR SYSTEMIC USE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2016-12-22

Informasjon til brukeren

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR TEVA 400 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 Teva is and what it is used for
2.
What you need to know before you take Darunavir Teva
3.
How to take Darunavir Teva
4.
Possible side effects
5.
How to store Darunavir Teva
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR TEVA IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR TEVA?
Darunavir Teva contains the active substance darunavir. Darunavir Teva
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 Teva 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 Teva 400 milligram 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 Teva 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 TEVA
DO NOT TAKE DARUNAVIR TEVA:
_ _
-
if you are

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 46
1
NAME OF THE MEDICINAL PRODUCT
Darunavir Teva 400 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of darunavir
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Darunavir Teva 400 mg are orange, film coated, oval shaped tablet,
debossed with "400" on one
side and plain on the other side with dimension of about 18.6-19.1 mm
X 9.1-9.6 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Darunavir Teva, 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 Teva, 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 Teva 400 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 plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100
cells x 10
6
/l. In
deciding to initiate treatment with Darunavir Teva in such
ART-experienced patients,
genotypic testing should guide the use of Darunavir Teva (see sections
4.2, 4.3, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a health care provider experienced in
the management of HIV
infection. After therapy with Darunavir Teva has been initiated,
patients should be advised not to
alter the dosage, dose form or discontinue therapy without discussing
with their health care
provider.
The interaction profile of darunavir depends on whether ritonavir or
cobicistat is used as
pharmacokinetic