Pazopanib CF 400 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

PAZOPANIBHYDROCHLORIDE 433,4 mg/stuk SAMENSTELLING overeenkomend met ; PAZOPANIB 400 mg/stuk

INN (Algemene Internationale Benaming):

PAZOPANIBHYDROCHLORIDE 433,4 mg/stuk SAMENSTELLING overeenkomend met ; PAZOPANIB 400 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PAZOPANIB CF 200 MG, FILMOMHULDE TABLETTEN
PAZOPANIB CF 400 MG, FILMOMHULDE TABLETTEN
pazopanib
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What 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 IS AND WHAT IT IS USED FOR
is a type of medicine called a _ protein kinase
inhibitor. _ It works by preventing the
activity of proteins that are involved in the growth and spread of
cancer cells.
is used in adults to treat:
-
kidney cancer that is advanced or has spread to other organs.
-
certain forms of soft-tissue sarcoma, which is a type of cancer that
affects the supportive tissues
of the body. It can occur in muscles, blood vessels, fat tissue or
other tissues that support,
surround and protect the organs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
-
IF YOU ARE ALLERGIC to pazopanib or any of the other ingredients of
this medicine (listed in section
6).
CHECK WITH YOUR DOCTOR if you think this applies to you.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking :
-
if you have HEART DISEASE.
-
if you have LIVER DISEASE.
-
if you have had HEART FAILURE OR A HEART ATTACK.
-
if you have had prior COLLAPSE OF A LUNG.
-
if you have had problems with BLEEDING, BLOOD CLOTS

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Pazopanib CF 200 mg, filmomhulde tabletten
Pazopanib CF 400 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ 200 mg film-coated tablets: _
Each tablet contains pazopanib hydrochloride equivalent to 200 mg
pazopanib
_ 400 mg film-coated tablets: _
Each tablet contains pazopanib hydrochloride equivalent to 400 mg
pazopanib
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_ 200 mg film-coated tablets: _
Capsule-shaped, pink, film-coated tablet with “200” debossed on
one side, with dimensions 14.3 mm x
5.7 mm approximately.
_ 400 mg film-coated tablets: _
Capsule-shaped, white, film-coated tablet with “400” debossed on
one side, with dimensions 18.0 mm
x 7.1 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Renal cell carcinoma (RCC)
is indicated in adults for the first-line treatment of
advanced renal cell carcinoma (RCC)
and for patients who have received prior cytokine therapy for advanced
disease.
Soft-tissue sarcoma (STS)
is indicated for the treatment of adult patients with
selective subtypes of advanced soft-
tissue sarcoma (STS) who have received prior chemotherapy for
metastatic disease or who have
progressed within 12 months after (neo) adjuvant therapy.
Efficacy and safety has only been established in certain STS
histological tumour subtypes (see section
5.1).
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
treatment should only be initiated by a physician
experienced in the administration of
anti-cancer medicinal products.
Posology
_Adults _
The recommended dose of pazopanib for the treatment of RCC or STS is
800 mg once daily.
_Dose modifications _
Dose modification (decrease or increase) should be in 200 mg
decrements or increments in a stepwise
fashion based on individual tolerability in order to manage adverse
reactions. The dose of pa