Sunitinib AqVida Capsules Hard 12.5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SUNITINIB

Available from:

AqVida GmbH Kaiser-Wilhelm-Str 89, 20355 Hamburg, Germany

ATC code:

L01XE04

INN (International Name):

SUNITINIB 12.5 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

SUNITINIB 12.5 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2018-02-07

Patient Information leaflet

pal-mt-en-sunitinib-aqvida-DE-H-4872-2021-11-08
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUNITINIB AQVIDA 12.5 MG
SUNITINIB AQVIDA 25 MG
SUNITINIB AQVIDA 37.5 MG
SUNITINIB AQVIDA 50 MG
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 or pharmacist.
–
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. This includes any
possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Sunitinib AqVida is and what it is used for
2.
What you need to know before you take Sunitinib AqVida
3.
How to take Sunitinib AqVida
4.
Possible side effects
5.
How to store Sunitinib AqVida
6.
Contents of the pack and other information
1.
WHAT SUNITINIB AQVIDA IS AND WHAT IT IS USED FOR
Sunitinib AqVida 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 AQVIDA 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 AqVida works or why this
medicine has been
prescribed for you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUNITINIB AQVIDA
DO NOT TAKE SUNITINIB AQVIDA

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sunitinib AqVida 12.5 mg hard capsules
Sunitinib AqVida 25 mg hard capsules
Sunitinib AqVida 37.5 mg hard capsules
Sunitinib AqVida 50 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 12.5 mg of
sunitinib.
25 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 25 mg of
sunitinib.
37.5 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 37.5 mg of
sunitinib.
50 mg hard capsules
Each capsule contains sunitinib malate, equivalent to 50 mg of
sunitinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Sunitinib AqVida 12.5 mg hard capsules
Gelatine capsules with orange cap and orange body, and containing
yellow to orange granules.
Sunitinib AqVida 25 mg hard capsules
Gelatine capsules with caramel cap and orange body, and containing
yellow to orange granules.
Sunitinib AqVida 37.5 mg hard capsules
Gelatine capsules with yellow cap and yellow body, and containing
yellow to orange granules.
Sunitinib AqVida 50 mg hard capsules
Gelatine capsules with caramel cap and caramel body, and containing
yellow to orange granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gastrointestinal stromal tumour (GIST)
Sunitinib 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 is indicated for the treatment of advanced/metastatic renal
cell carcinoma (MRCC) in adults.
2
Pancreatic neuroendocrine tumours (pNET)
Sunitinib 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 should be initiated by a physician experienced
in the administration o