Rubraca
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-02-2024
Karatteristiċi tal-prodott
(SPC)
15-02-2024
Rapport ta 'Valutazzjoni Pubblika
(PAR)
30-11-2023
Ingredjent attiv:
rucaparib camsylate
Disponibbli minn:
pharmaand GmbH
Kodiċi ATC:
L01XX
INN (Isem Internazzjonali):
rucaparib
Grupp terapewtiku:
Antineoplastic agents
Żona terapewtika:
Ovarian Neoplasms
Indikazzjonijiet terapewtiċi:
Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Sommarju tal-prodott:
Revision: 15
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-05-23
Fuljett ta 'informazzjoni
39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RUBRACA 200 MG FILM-CO
ATED TABLETS
RUBRACA 250 MG FILM-COATED TABLETS
RUBRACA 300 MG FILM-COATED TABLETS
rucaparib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Rubraca is and what it is used for
2.
What you need to know before you take Rubraca
3.
How to take Rubraca
4.
Possible side effects
5.
How to store Rubraca
6.
Contents of the pack and other information
1.
WHAT RUBRACA IS AND WHAT IT IS USED FOR
WHAT RUBRACA IS AND HOW IT WORKS
Rubraca contains the active substance rucaparib. Rubraca is an
anti-cancer medicine, also known as a
‘PARP (poly adenosine diphosphate-ribose polymerase) inhibitor’.
Patients with changes (mutations) in genes called BRCA are at risk of
developing a number of types of
cancer. Rubraca blocks an enzyme that repairs damaged DNA in the
cancer cells, resulting in their
death.
WHAT RUBRACA IS USED FOR
Rubraca is used to treat a type of cancer of the ovary. It is used as
maintenance therapy immediately
after a course of chemotherapy that has caused the tumour to shrink.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RUBRACA
DO NOT TAKE RUBRACA
•
if you are allergic to rucaparib or any of the other ingredients of
this medicine (listed in
section 6)
•
if y
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rubraca 200 mg film-coated tablets
Rubraca 250 mg film-coated tablets
Rubraca 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rubraca 200 mg film
-coated tablets
Each tablet contains rucaparib camsylate corresponding to 200 mg
rucaparib.
Rubraca 250 mg film
-coated tablets
Each tablet contains rucaparib camsylate corresponding to 250 mg
rucaparib.
Rubraca 300 mg film
-coated tablets
Each tablet contains rucaparib camsylate corresponding to 300 mg
rucaparib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Rubraca 200 mg film
-coated tablet
Blue, 11 mm, round film-coated tablet, debossed with “C2”.
Rubraca 250 mg film
-coated tablet
White, 11 × 15 mm, diamond-shaped film-coated tablet, debossed with
“C25”.
Rubraca 300 mg film
-coated tablet
Yellow, 8 × 16 mm, oval film-coated tablet, debossed with “C3”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rubraca is indicated as monotherapy for the maintenance treatment of
adult patients with advanced
(FIGO Stages III and IV) high-grade epithelial ovarian, fallopian
tube, or primary peritoneal cancer
who are in response (complete or partial) following completion of
first-line platinum-based
chemotherapy.
3
Rubraca is indicated as monotherapy for the maintenance treatment of
adult patients with platinum-
sensitive relapsed high-grade epithelial ovarian, fallopian tube, or
primary peritoneal cancer who are
in response (complete or partial) to platinum-based chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Rubraca should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
Posology
The recomm
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