Darunavir Teva Tablet, film coated 600mg

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 600 mEq/ml

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

DARUNAVIR 600 mEq/ml

Resept typen:

POM

Terapeutisk område:

ANTIVIRALS FOR SYSTEMIC USE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2016-12-22

Informasjon til brukeren

Page 1 of 12
PACKAGE LEAFLET
Page 2 of 12
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR TEVA 600 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 is used to treat adults who are infected by HIV and who
have already used other
antiretroviral medicines and children of 3 years of age and above, and
at least 15 kilogram body
weight who are infected by HIV.
Darunavir Teva 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 TEVA
DO NOT TAKE DARUNAVIR TEVA:
_ _
-
if you are ALLERGIC to darunavir or any of the other ingredients of
this medicine (listed i

Preparatomtale

Page 1 of 40
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 40
1
NAME OF THE MEDICINAL PRODUCT
Darunavir Teva 600 mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of darunavir.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Darunavir Teva 600 mg are orange, film coated, oval shaped tablet,
scored and debossed with
"600" on the left side of the score on one side and plain on the other
side with dimension of about
21.4-21.9 mm X 10.4-10.9 mm.
The tablet can be divided into equal doses.
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 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 Teva 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
Teva.
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.
Posology
Darunavir Teva must always be given orally with low dose ritonavir as
a pharmacokinetic enhancer
and in combination with oth