ABIRATERON DOC 500 mg, filmomhulde tabletten

국가: 네덜란드

언어: 네덜란드어

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

유효 성분:

ABIRATERONACETAAT 500 mg/stuk

제공처:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

INN (국제 이름):

ABIRATERONACETAAT 500 mg/stuk

약제 형태:

Filmomhulde tablet

구성:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

관리 경로:

Oraal gebruik

승인 날짜:

1900-01-01

환자 정보 전단

NL/H/4967/001-002/DC – EoP xx.xx.2021 – proposed for national
phase according to MEB41 “MEB policy
concerning marketing authorisations without Dutch translations of the
product information and/or mock-ups”
Page 1 a 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABIRATERON DOC 500 MG, FILMOMHULDE 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 DOC is and what it is used for
2.
What you need to know before you take ABIRATERON DOC
3.
How to take ABIRATERON DOC
4.
Possible side effects
5.
How to store ABIRATERON DOC
6.
Contents of the pack and other information
1.
WHAT ABIRATERON DOC IS AND WHAT IT IS USED FOR
ABIRATERON DOC 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 DOC stops
your body from making testosterone;
this can slow the growth of prostate cancer.
When ABIRATERON DOC 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 DOC
_ _
DO NOT TAKE ABIRATERON DOC:
-
if you are al

제품 특성 요약

NL/H/4967/001-002/DC – EoP 10.03.2021 – proposed for national
phase according to MEB41 “MEB policy
concerning marketing authorisations without Dutch translations of the
product information and/or mock-ups”
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
ABIRATERON DOC 500 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500 mg of abiraterone acetate.
Excipients with known effect
Each tablet contains 241 mg of lactose and 12 mg sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Oval-shaped purple film-coated tablet, approximately 19 mm long by 11
mm wide and debossed with “A7TN”
on one side and “500” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ABIRATERON DOC 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 DOC is used with 5 mg prednisone or prednisolone
daily.
For mCRPC, ABIRATERON DOC is used with 10 mg prednisone or
prednisolone daily.
Medical castratio