Abirateron betapharm 250 mg, tabletten

Страна: Нідерланди

мова: голландська

Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активний інгредієнт:

ABIRATERONACETAAT 250 mg/stuk

Доступна з:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

ІПН (Міжнародна Ім'я):

ABIRATERONACETAAT 250 mg/stuk

Фармацевтична форма:

Tablet

Склад:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551)

Адміністрація маршрут:

Oraal gebruik

Дата Авторизація:

1900-01-01

інформаційний буклет

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABIRATERON BETAPHARM 250 MG, TABLETTEN
abirateron acetaat
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 Abirateron betapharm is and what it is used for
2.
What you need to know before you take Abirateron betapharm
3.
How to take Abirateron betapharm
4.
Possible side effects
5.
How to store Abirateron betapharm
6.
Contents of the pack and other information
1.
WHAT ABIRATERON BETAPHARM IS AND WHAT IT IS USED FOR
Abirateron betapharm contains a medicine called abiraterone acetate.
It is used to treat prostate cancer in adult
men that has spread to other parts of the body. Abirateron betapharm
stops your body from making testosterone;
this can slow the growth of prostate cancer.
When Abirateron betapharm is prescribed for the early stage of disease
where it is still responding to hormone
therapy, it is used with a treatment that lowers testosterone
(androgen deprivation therapy).
When you take this medicine your doctor will also prescribe another
medicine called prednisone or
prednisolone. This is to lower your chances of getting high blood
pressure, having too much water in your body
(fluid retention), or having reduced levels of a chemical known as
potassium in your blood.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ABIRATERON BETAPHARM
_ _
DO NOT TAKE ABIRATERON BETAPHARM:
-
if you are allergic to abiraterone acetate or any of the other
ingredients of this medicine (listed in section
6).
-
if you are a woman, especially if pregnant. Abirateron betapharm is

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ABIRATERON BETAPHARM 250 MG, TABLETTEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 180 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white oval tablet, approximately 16 mm long by 9.5 mm
wide, debossed with “ATN” on one side
and “250” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abirateron betapharm is indicated with prednisone or prednisolone for:
-
the treatment of newly diagnosed high risk metastatic hormone
sensitive prostate cancer (mHSPC) in adult
men in combination with androgen deprivation therapy (ADT) (see
section 5.1)
-
the
treatment
of
metastatic
castration
resistant
prostate
cancer
(mCRPC)
in
adult
men
who
are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom chemotherapy
is not yet clinically indicated (see section 5.1)
-
the treatment of mCRPC in adult men whose disease has progressed on or
after a docetaxel-based
chemotherapy regimen.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should be prescribed by an appropriate
healthcare professional.
Posology
The recommended dose is 1,000 mg (four 250 mg tablets or two 500 mg
tablets) as a single daily dose that must
not be taken with food (see “Method of administration” below).
Taking the tablets with food increases systemic
exposure to abiraterone (see sections 4.5 and 5.2).
_Dosage of prednisone or prednisolone_
For mHSPC, Abirateron betapharm is used with 5 mg prednisone or
prednisolone daily.
For mCRPC, Abirateron betapharm is used with 10 mg prednisone or
prednisolone daily.
Medical castration with luteinising hormone releasing hormone (LHRH)
analogue should be continued during
treatment in patients not surgically castrated.
_Recommended monitoring_
Serum transaminases should be measured prior to starting treatment,
every two w