Sunitinib Accord

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

sunitinib

Διαθέσιμο από:

Accord Healthcare S.L.U.

Φαρμακολογική κατηγορία (ATC):

L01EX01

INN (Διεθνής Όνομα):

sunitinib

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors

Θεραπευτικές ενδείξεις:

Gastrointestinal stromal tumour (GIST)Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance.Metastatic renal cell carcinoma (MRCC)Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.Pancreatic neuroendocrine tumours (pNET)Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

Περίληψη προϊόντος:

Revision: 1

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2021-02-11

Φύλλο οδηγιών χρήσης

75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB ACCORD 12.5 MG HARD CAPSULES
SUNITINIB ACCORD 25 MG HARD CAPSULES
SUNITINIB ACCORD 37.5 MG HARD CAPSULES
SUNITINIB ACCORD 50 MG HARD CAPSULES
sunitinib
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 Sunitinib Accord is and what it is used for
2.
What you need to know before you take Sunitinib Accord
3.
How to take Sunitinib Accord
4.
Possible side effects
5.
How to store Sunitinib Accord
6.
Contents of the pack and other information
1.
WHAT SUNITINIB ACCORD IS AND WHAT IT IS USED FOR
Sunitinib Accord contains the active substance sunitinib, which is a
protein kinase inhibitor. It is
used
to treat cancer by preventing the activity of a special group of
proteins which are known to be involved
in the growth and spread of cancer cells.
Sunitinib Accord is used to treat adults with the following types of
cancer:
-
Gastrointestinal stromal tumour (GIST), a type of cancer of the
stomach and bowel, where
imatinib (another anticancer medicine) no longer works or you cannot
take imatinib.
-
Metastatic renal cell carcinoma (MRCC), a type of kidney cancer that
has spread to other parts
of the body.
-
Pancreatic neuroendocrine tumours (pNET) (tumours of the
hormone-producing cells in the
pancreas) that have progressed or cannot be removed with surgery.
If you have any questions about how Sunitinib Accord works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SU

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib Accord 12.5 mg hard capsules
Sunitinib Accord 25 mg hard capsules
Sunitinib Accord 37.5 mg hard capsules
Sunitinib Accord 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sunitinib Accord 12.5 mg hard c apsules
Each hard capsule contains 12.5 mg of sunitinib.
Sunitinib Accord 25 mg hard c apsules
Each hard capsule contains 25 mg of sunitinib.
Sunitinib Accord 37.5 mg hard c apsules
Each hard capsule contains 37.5 mg of sunitinib.
Sunitinib Accord 50 mg hard c apsules
Each hard capsule contains 50 mg of sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Sunitinib Accord 12.5 mg hard capsules
Gelatin capsules of size 4 (approximate length 14.3 mm) with orange
cap and orange body, printed
with white ink “12.5 mg” on the body, and containing yellow to
orange granules.
Sunitinib Accord 25 mg hard capsules
Gelatin capsules of size 3 (approximate length 15.9 mm) with caramel
cap and orange body, printed
with white ink “25 mg” on the body, and containing yellow to
orange granules.
Sunitinib Accord 37.5 mg hard capsules
Gelatin capsules of size 2 (approximate length 18.0 mm) with yellow
cap and yellow body, printed
with black ink “37.5 mg” on the body, and containing yellow to
orange granules.
Sunitinib Accord 50 mg hard capsules
Gelatin capsule of size 1 (approximate length 19.4 mm) with caramel
cap and caramel body, printed
with white ink “50 mg” on the body, and containing yellow to
orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib Accord is indicated for the treatment of unresectable and/or
metastatic malignant
gastrointestinal stromal tumour (GIST) in adults after failure of
imatinib treatment due to resistance or
intolerance.
3
Metastatic renal cell carcinoma (MRCC)
Sunitinib Accord is indicated for the treatment of advanced/metastatic
renal cell carcinoma (MRCC)
in adult