EDURANT TABLET

Страна: ЮАР

Язык: английский

Источник: South African Health Products Regulatory Authority (SAHPRA)

Доступна с:

Janssen Pharmaceutica (Pty) Ltd

дозировка:

Not Indicated

Фармацевтическая форма:

TABLET

состав:

None

Статус Авторизация:

Registered

Дата Авторизация:

2013-05-12

тонкая брошюра

_APPLICANT: _
JANSSEN PHARMACEUTICA (PTY) LTD_ _
_ _
_PRODUCT PROPRIETARY NAME_:_ _
EDURANT
_DOSAGE FORM: _
FILM COATED TABLETS
_STRENGTH(S): _
RILPIVIRINE 25 MG PER TABLET
_ _
_ _
_Page 1 of 12 _
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
EDURANT
Film-coated tablet
contains 25 mg of rilpivirine as rilpivirine hydrochloride
Contains sugar: Each film-coated tablet contains 56,113 mg lactose
monohydrate.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN EDURANT
FILM-COATED
TABLET
•
Keep this leaflet. You may need to read it again.
•
EDURANT has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the
same as yours.
•
Ask your health care provider or pharmacist if you need more
information or
advice.
WHAT IS IN THIS LEAFLET
1. What
EDURANT
is and what it is used for
2. What you need to know before you take
EDURANT
3. How to take
EDURANT
4. Possible side effects
Schedule 4
_APPLICANT: _
JANSSEN PHARMACEUTICA (PTY) LTD_ _
_ _
_PRODUCT PROPRIETARY NAME_:_ _
EDURANT
_DOSAGE FORM: _
FILM COATED TABLETS
_STRENGTH(S): _
RILPIVIRINE 25 MG PER TABLET
_ _
_ _
_Page 2 of 12 _
5. How to store
EDURANT
6. Contents of the pack and other information
1. WHAT EDURANT IS AND WHAT IT IS USED FOR
EDURANT is a medicine used for the treatment of Human Immunodeficiency
Virus (HIV)
infection. It belongs to a group of HIV medicines called
non-nucleoside reverse
transcriptase inhibitors (NNRTIs). EDURANT 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.
EDURANT is always used in combination with other HIV medicines to
treat patients 12
years of age and older who are infected by HIV and who have never been
treated before
with 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 EDURANT
DO NOT TAKE EDURANT
•
If you are ALLERGIC (hypersensitive) to rilpivi

Характеристики продукта

_APPLICANT: _
JANSSEN PHARMACEUTICA (PTY) LTD_ _
_ _
_PRODUCT PROPRIETARY NAME_:_ _
EDURANT
_DOSAGE FORM: _
FILM COATED TABLETS
_STRENGTH(S): _
RILPIVIRINE 25 MG PER TABLET
_ _
_Page 1 of 35 _
PROFESSIONAL INFORMATION INSERT
SCHEDULING STATUS
Schedule 4
1.
NAME OF THE MEDICINE
EDURANT 25 MG (film-coated tablet)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet of EDURANT contains 25 mg rilpivirine as
rilpivirine hydrochloride.
Contains sugar: Each film-coated tablet contains 56,113 mg lactose
monohydrate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White to off-white, film-coated, round, biconvex tablet, debossed with
“TMC” on one side
and “25” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULT PATIENTS
EDURANT, in combination with other antiretroviral medicines, is
indicated for the treatment
of human immunodeficiency virus type 1 (HIV-1) infection in
antiretroviral treatment-naïve
adult patients.
Schedule 4
_APPLICANT: _
JANSSEN PHARMACEUTICA (PTY) LTD_ _
_ _
_PRODUCT PROPRIETARY NAME_:_ _
EDURANT
_DOSAGE FORM: _
FILM COATED TABLETS
_STRENGTH(S): _
RILPIVIRINE 25 MG PER TABLET
_ _
_Page 2 of 35 _
PAEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE)
EDURANT, in combination with other antiretroviral medicinal products,
is indicated for the
treatment of human immunodeficiency virus type 1 (HIV-1) infection in
antiretroviral
treatment-naïve paediatric patients 12 to less than 18 years of age
with a viral load of ≤
100000 HIV-1 RNA copies/mL.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
EDURANT must always be given in combination with other antiretroviral
medicinal
products.
ADULTS AND PAEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE)
The recommended dose of EDURANT is 25 mg once-daily taken orally with
a meal.
_Dose adjustment with rifabutin coadministration _
For patients concomitantly receiving rifabutin, the EDURANT dose
should be increased to
50 mg (two tablets of 25 mg each) once daily, taken with a meal. When
rifabutin co
admi