DARUNAVIR CLONMEL 400 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

DARUNAVIR

Commercializzato da:

Clonmel Healthcare Ltd

Codice ATC:

J05AE10

INN (Nome Internazionale):

DARUNAVIR

Dosaggio:

400 Milligram

Forma farmaceutica:

Film Coated Tablet

Tipo di ricetta:

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

Area terapeutica:

Protease inhibitors

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2017-06-02

Foglio illustrativo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DARUNAVIR CLONMEL 400MG FILM-COATED TABLETS
DARUNAVIR CLONMEL 800MG 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 or pharmacist.
-
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Darunavir Clonmel is and what it is used for
2.
What you need to know before you take Darunavir Clonmel
3.
How to take Darunavir Clonmel
4.
Possible side effects
5.
How to store Darunavir Clonmel
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR CLONMEL IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR CLONMEL?
Darunavir
Clonmel
contains
the
active
substance
darunavir.
Darunavir
Clonmel
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 Clonmel
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 Clonmel 400 mg/800mg is used to treat adults and children (3
years of age and
above, at least 40 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 Clonmel 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

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Darunavir Clonmel 400 mg film
-
coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
-
coated tablet contains 400 mg of darunavir.
Excipient 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, with
dimensions of approximately 17.1 mm x 8.6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Darunavir
Clonmel,
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 Clonmel,
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 Clonmel 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
Clonmel
in such ART
-
experienced patients,
genotypic testing should guide the use of
Darunavir
Clonmel (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 Clonmel has been initiated, patients should be advised
not to alter the dosage, dose form or discontinue
therapy without discussing with their health care provider.
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