Bixodalan 1000 mg, filmomhulde tabletten

Land: Niederlande

Sprache: Niederländisch

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

Wirkstoff:

ABIRATERONACETAAT 1000 mg/stuk

INN (Internationale Bezeichnung):

ABIRATERONACETAAT 1000 mg/stuk

Darreichungsform:

Filmomhulde tablet

Zusammensetzung:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLYVINYLALCOHOL (E 1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYVINYLALCOHOL (E1203) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Verabreichungsweg:

Oraal gebruik

Berechtigungsdatum:

1900-01-01

Gebrauchsinformation

1
Sandoz B.V.
Bixodalan 1000 mg, filmomhulde tabletten
Page 1/6
RVG 126635
1313-v1
1.3.1.3 Bijsluiter
Juli 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIXODALAN 1000 MG, FILMOMHULDE TABLETTEN
abirateronacetaat
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
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.
stops your
body from making testosterone; this can slow the growth of prostate
cancer.
When 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
DO NOT TAKE
-
if you are allergic to abiraterone acetate or any of the other
ingredients of this medicine
(listed in section 6).
-
if y

Fachinformation

Sandoz B.V.
Page 1/27
Bixodalan 1000 mg, filmomhulde tabletten
RVG 126635
1311-v1
1.3.1.1 Samenvatting van de productkenmerken
Juli 2021
1.
NAME OF THE MEDICINAL PRODUCT
Bixodalan 1000 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1000 mg of abiraterone acetate.
Excipient with known effect
Each film-coated tablet contains 129.21 mg of lactose (136 mg as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film – coated tablet.
White to off-white, oval-shaped film-coated tablets, with a break line
on one side and plain on the
other side, with dimensions 23.1 mm x 11.1 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 1000 mg (one tablet) as a single daily dose
that must not be taken with
food (see “Method of administration” below). Taking the tablet
with food increases systemic
exposure to abiraterone (see sections 4.5 and 5.2).
_Dosage of _
prednisone or
_prednisolone_
For mHSPC, is used with 5 mg prednisone or prednisolone
daily.
For mCRPC, is used with 10 mg prednisone or
prednisolone daily.
Medical castration with luteinising hormone releasing hormone (LHRH)
analogue