Sunitinib Bluefish 12.5 mg hard capsules

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Sunitinib

Dostopno od:

Bluefish Pharmaceuticals AB

Koda artikla:

L01EX01

INN (mednarodno ime):

Sunitinib

Farmacevtska oblika:

Capsule, hard

Terapevtsko območje:

sunitinib

Status dovoljenje:

Not marketed

Datum dovoljenje:

2023-02-17

Navodilo za uporabo

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SUNITINIB BLUEFISH 12.5 MG HARD CAPSULES
SUNITINIB BLUEFISH 25 MG HARD CAPSULES
SUNITINIB BLUEFISH 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 Bluefish is and what it is used for
2.
What you need to know before you take Sunitinib Bluefish
3.
How to take Sunitinib Bluefish
4.
Possible side effects
5.
How to store Sunitinib Bluefish
6.
Contents of the pack and other information
1.
WHAT SUNITINIB BLUEFISH IS AND WHAT IT IS USED FOR
Sunitinib Bluefish 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 Bluefish 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 Bluefish works or why
this medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB BLUEFISH
DO NOT TAKE SUNITIN

Lastnosti izdelka

HealthProductsRegulatoryAuthority
03March2023
CRN00CSQ2
Page1of23
SUMMARYOFPRODUCTCHARACTERISTICS
1NAMEOFTHEMEDICINALPRODUCT
SunitinibBluefish12.5mghardcapsules
2QUALITATIVEANDQUANTITATIVECOMPOSITION
Eachcapsulecontains12.5mgofsunitinib.
Forthefulllistofexcipients,seesection6.1.
3PHARMACEUTICALFORM
Hardcapsule
Hardcapsulewithorangecapandorangebody,printedwithwhiteink'SB12.5'andwhitelineonthebodyandcontaining
yellowtoorangegranules,withanominallengthofapproximately14mm.
4CLINICALPARTICULARS
4.1THERAPEUTICINDICATIONS
Gastrointestinal stromal tumour (GIST)
SunitinibBluefish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Bluefishisindicatedforthetreatmentofadvanced/metastaticrenalcellcarcinoma(MRCC)inadults.
Pancreatic neuroendocrine tumours (pNET)
SunitinibBluefishisindicatedforthetreatmentofunresectableormetastatic,well-differentiatedpancreaticneuroendocrine
tumours(pNET)withdiseaseprogressioninadults.
4.2POSOLOGYANDMETHODOFADMINISTRATION
TherapywithSunitinibBluefishshouldbeinitiatedbyaphysicianexperiencedintheadministrationofanticanceragents.
Posology
ForGISTandMRCC,therecommendeddoseofSunitinibBluefishis50mgtakenorallyoncedaily,for4consecutiveweeks,
followedbya2-weekrestperiod(Schedule4/2)tocompriseacompletecycleof6weeks.
ForpNET,therecommendeddoseof�