Intelence
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
28-11-2022
Charakterystyka produktu
(SPC)
28-11-2022
Sprawozdanie z oceny publicznego
(PAR)
15-05-2020
Składnik aktywny:
Etravirine
Dostępny od:
Janssen-Cilag International NV
Kod ATC:
J05AG04
INN (International Nazwa):
etravirine
Grupa terapeutyczna:
Non-nucleoside reverse transcriptase inhibitors, Antivirals for systemic use
Dziedzina terapeutyczna:
HIV Infections
Wskazania:
Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.
Podsumowanie produktu:
Revision: 30
Status autoryzacji:
Authorised
Data autoryzacji:
2008-08-28
Ulotka dla pacjenta
45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
INTELENCE 25 MG TABLETS
etravirine
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 INTELENCE is and what it is used for
2.
What you need to know before you take INTELENCE
3.
How to take INTELENCE
4.
Possible side effects
5.
How to store INTELENCE
6.
Contents of the pack and other information
1.
WHAT INTELENCE IS AND WHAT IT IS USED FOR
INTELENCE contains the active substance etravirine. INTELENCE belongs
to a group of anti-HIV
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs).
INTELENCE is a medicine used for the treatment of Human
Immunodeficiency Virus (HIV)
infection. INTELENCE 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.
INTELENCE is used in combination with other anti-HIV medicines to
treat adults and children
2 years of age and older who are infected by HIV and who have used
other anti-HIV medicines before.
Your doctor will discuss with you which combination of medicines is
best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INTELENCE
DO NOT TAKE INTELENCE
-
if you are allergic to etravirine or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis
C infection).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking INTELENCE.
INTELENCE is not a cure for HIV infection. It is part of a t
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
INTELENCE 25 mg tablets
INTELENCE 100 mg tablets
INTELENCE 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
INTELENCE 25 mg tablets
Each tablet contains 25 mg of etravirine.
Excipient with known effect
Each tablet contains 40 mg lactose (as monohydrate).
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free.
INTELENCE 100 mg tablets
Each tablet contains 100 mg of etravirine.
Excipient with known effect
Each tablet contains 160 mg lactose (as monohydrate).
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free.
INTELENCE 200 mg tablets
Each tablet contains 200 mg of etravirine.
Excipient with known effect
Each tablet contains less than 1 mmol sodium (23 mg), and is
essentially sodium-free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
INTELENCE 25 mg tablets
Tablet
White to off-white, oval, scored tablet, debossed with “TMC” on
one side.
The tablet can be divided into two equal doses.
INTELENCE 100 mg tablets
Tablet
White to off-white, oval tablet debossed with “T125” on one side
and “100” on the other side.
INTELENCE 200 mg tablets
Tablet
White to off-white, biconvex, oblong tablet debossed with “T200”
on one side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTELENCE, in combination with a boosted protease inhibitor and other
antiretroviral medicinal
products, is indicated for the treatment of human immunodeficiency
virus type 1 (HIV-1) infection in
antiretroviral treatment-experienced adult patients and in
antiretroviral treatment-experienced
paediatric patients from 2 years of age (see sections 4.4, 4.5 and
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
INTELENCE must always be given in combination with other
antiretroviral medicinal products.
_Adults_
The recommended dose of etravirine for adults is 200 mg (on
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