INTELENCE etravirine 100 mg tablet bottle

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

etravirine, Quantity: 100 mg

Доступна с:

Janssen-Cilag Pty Ltd

ИНН (Международная Имя):

Etravirine

Фармацевтическая форма:

Tablet

состав:

Excipient Ingredients: hypromellose; croscarmellose sodium; magnesium stearate; lactose monohydrate; microcrystalline cellulose; colloidal anhydrous silica

Администрация маршрут:

Oral

Штук в упаковке:

120 tablet

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

Etravirine, in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to non-nucleoside transcriptase inhibitors and other antiretroviral agents.,This indication is based on 24-week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N(t)RTI, PI) treatment-experienced adults (see section 5.1 Pharmacodynamic properties ? Clinical trials).,Treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

Обзор продуктов:

Visual Identification: White to off-white, oval tablet, debossed with "T125" on one side and "100" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2008-12-19

тонкая брошюра

INTELENCE
®
(170905) ACMI
1
INTELENCE
® TABLETS
_etravirine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about INTELENCE tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
INTELENCE against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN INTELENCE ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING INTELENCE.
You may need to read it again.
WHAT INTELENCE IS
USED FOR
INTELENCE is a medicine used for
the treatment of Human
Immunodeficiency Virus (HIV)
infection. It belongs to a group of
anti-HIV medicines called non-
nucleoside reverse transcriptase
inhibitors (NNRTIs). INTELENCE
works by reducing the amount of
HIV in your body. This will improve
your immune system and reduce the
risk of developing illnesses linked to
HIV infection.
INTELENCE is used to treat adults
who are infected by HIV and who
have used other anti-HIV medicines
before. INTELENCE can be used by
patients infected with HIV that is
resistant to other NNRTIs.
INTELENCE must be taken in
combination with other anti-HIV
medicines. Your doctor will discuss
with you which combination of
medicines is best for you.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY INTELENCE
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
INTELENCE
WHEN YOU MUST NOT USE IT:
DO NOT TAKE INTELENCE:
•
if you are allergic
(hypersensitive) to etravirine, or
other ingredients of
INTELENCE. See Product
Description at the end of this
leaflet for a list of ingredients.
DO NOT TAKE INTELENCE:
•
if the packaging is torn or shows
signs of tampering.
•
if the expiry date (month and
year) printed on the pack has
passed. If you take
INTELENCE after the expiry
date it may not work.
DO NOT COMBINE INTELENCE WITH
ANY OF THE FOLLOWING MEDICINES:
•
ca

Характеристики продукта

CCDS181010v20
INTELENCE (190408) API
INTELENCE
®
E
TRAVIRINE
A
USTRALIAN
P
RODUCT
I
NFORMATION
1. NAME OF THE MEDICINE
Etravirine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
INTELENCE etravirine is available as 100 mg and 200 mg tablets.
Each tablet contains 100 mg or 200 mg of etravirine.
Excipient(s) with known effect:
The 100 mg tablets contain 160 mg of lactose monohydrate.
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Tablet
INTELENCE 100 mg tablet: white to off-white, oval tablet, debossed
with “T125” on one
side and “100” on the other side*.
INTELENCE 200 mg tablet: white to off-white, biconvex, oblong tablet,
debossed with
“T200” on one side.
Etravirine
is
a
non-nucleoside
reverse
transcriptase
inhibitor
(NNRTI)
of
human
immunodeficiency virus type 1 (HIV-1).
INTELENCE (etravirine) is a substituted diarylpyrimidine (DAPY)
derivative, with potent
_in vitro _activity against wild-type HIV-1 as well as NNRTI-resistant
HIV-1.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etravirine, in combination with other antiretroviral agents is
indicated for the treatment of
HIV-1 infection in antiretroviral treatment-experienced adults who
have evidence of viral
replication
and
resistance
to
non-nucleoside
transcriptase
inhibitors
and
other
antiretroviral agents.
This indication is based on 24-week analyses from 2 randomised,
double-blind, placebo
controlled trials of etravirine. Both studies were conducted in
clinically advanced, 3-class
antiretroviral
(NNRTI,
N(t)RTI,
PI)
treatment-experienced
adults
(see
SECTION
5.1
PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
Treatment history of patients and genotypic testing should be
performed to guide the use
of etravirine.
CCDS181010v20
2
INTELENCE (190408) API
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE (DOSE AND INTERVAL)
INTELENCE must always be given in combination with other
antiretroviral medicinal
products.
_ADULTS: _
The recommended oral dose of INTELENCE is 200 mg (one 200 mg tablet or
two 100 mg
table