INTELENCE 100 MG TABLETS

국가: 말레이시아

언어: 영어

출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

유효 성분:

ETRAVIRINE

제공처:

JOHNSON & JOHNSON SDN BHD

INN (International Name):

ETRAVIRINE

패키지 단위:

120Tablet Tablets

Manufactured by:

JANSSEN CILAG SPA

환자 정보 전단

INTELENCE
® TABLET
ETRAVIRINE (100MG)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What Intelence
®
is used for
2.
How Intelence
®
works
3.
Before you use Intelence
®
4.
How to use Intelence
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Intelence
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
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 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.
HOW INTELENCE
® WORKS
Intelence contains an active ingredient,
etravirine. 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.
BEFORE YOU USE INTELENCE
®
_-_
_ _
_When you must not use it_
Do not take Intelence if you are
allergic (hypersensitive) to etravirine
or any of the other ingredients of
Intelence. These other ingredients are
listed in “Product Description”.
_ _
_Pregnancy and Breastfeeding _
Tell your doctor immediately if you
are pregnant. Pregnant women should
not take Intelence unless specifically
directed by the doctor.
HIV infected mothers must not breast-
feed, as there is a possibility of
infecting the baby with HIV.
_-_
_ _
_Before you start to use it _
Intelence must be taken in
combination with other anti-HIV
medicines. It is therefore important
that you carefully read this leaflet. If
you have any further questions about
the medicines prescribed, please ask
your doctor or pharmacist.
Intelence is not for

제품 특성 요약

- 1 -
PRODUCT NAME
INTELENCE ® 100 mg tablets.
DOSAGE FORMS AND STRENGTHS
Each tablet contains 100 mg of etravirine.
Excipient: Each tablet contains 160 mg lactose.
For a full list of excipients, see Pharmaceutical Information - List of Excipients .
PHARMACEUTICAL FORM
White to off -white, oval tablet, debossed with “ T125” on one side and “100” on the other side.
CLINICAL INFORMATION
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 (see Warnings and
Precautions , Interaction s and Pharmacodynamic Properties ).
Th e indication in adults is based on week 48 analyses from 2 Phase III trials in highly pre -
treated patients where INTELENCE was investigated in combination with an optimised
background regimen (OBR) which included darunavir/ritonavir . (see Pharmaco logical
Properties – Pharmacodynamic Properties).
Dosage and Administration
Therapy should be initiated by a physician experienced in the management of HIV infection.
INTELENCE must always be given in combination with other antiretroviral medicinal
products.
Adults
The recommended dose of INTELENCE is 200 mg (two 100 mg tablets) taken orally twice
daily (b.i.d.), following a meal (see Pharmacokinetic Properties ).
Special populations
Elderly
There is limited informatio n regarding the use of INTELENCE in patients > 65 years of age
(see Clinical Information – Warnings and Precautions and Pharmacological Properties –
Pharmacokinetic Properties ), therefore caution should be used in this population.
Pregnancy
No dose adjustment is required during pregnancy and postpartum. Given the increased
etravirine exposure during pregnancy, caution should be applied for those pregnant patients
that require concomitant medications or have comorbidities that may further increase etr avirine
exposure.
Renal impairment
No dose adjustment is required in