Bixodalan 500 mg filmomhulde tabletten

国家: 荷兰

语言: 荷兰文

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

有效成分:

ABIRATERONACETAAT 500 mg/stuk

可用日期:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN（国际名称）:

ABIRATERONACETAAT 500 mg/stuk

药物剂型:

Filmomhulde tablet

组成:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; 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) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; 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)

给药途径:

Oraal gebruik

授权日期:

1900-01-01

资料单张

1
Sandoz B.V.
Page 1/5
Bixodalan 250, 500 mg, filmomhulde tabletten
RVG 126069-70
1313-V1
1.3.1.3 Package Leaflet
April 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER BIXODALAN 250 MG FILMOMHULDE TABLETTEN
BIXODALAN 500 MG FILMOMHULDE TABLETTEN
abiraterone acetate
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 Bixodalan 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 BIXODALAN IS AND WHAT IT IS USED FOR
Bixodalan 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. Bixodalan stops your body
from making testosterone; this can
slow the growth of prostate cancer.
When Bixodalan 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 BIXODALAN
DO NOT TAKE
-
if you are allergic to abiraterone acetate or any of the other
ingredients of this medicine (listed

产品特点

1
Sandoz B.V.
Page 1/23
Bixodalan 250, 500 mg, filmomhulde tabletten
RVG 126069-70
1311-V1
1.3.1.1 Summary of Product Characteristics
April 2021
1.
NAME OF THE MEDICINAL PRODUCT
Bixodalan 250 mg filmomhulde tabletten
Bixodalan 500 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg of abiraterone acetate.
Each film-coated tablet contains 500 mg of abiraterone acetate.
Excipient with known effect
Each film-coated tablet contains 32.3 mg of lactose (34 mg as
monohydrate).
Each film-coated tablet contains 64.6 mg of lactose (68 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, debossed with
“250” on one side, with dimensions
of 14.2 mm x 7.2 mm.
Purple, oval-shaped film-coated tablets, debossed with “500” on
one side, with dimensions of 18.9 mm x
9.5 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bixodalan 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 _
pred