Lapatinib STADA Arzneimittel AG 250 mg, filmomhulde tabletten

Country: নেদারল্যান্ডস

ভাষা: ডাচ

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

সক্রিয় উপাদান:

LAPATINIBDITOSILAAT 1-WATER 405 mg/stuk SAMENSTELLING overeenkomend met ; LAPATINIB 250 mg/stuk

INN (International Name):

LAPATINIBDITOSILAAT 1-WATER 405 mg/stuk SAMENSTELLING overeenkomend met ; LAPATINIB 250 mg/stuk

ফার্মাসিউটিকাল ফর্ম:

Filmomhulde tablet

রচনা:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; 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) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; TITAANDIOXIDE (E 171)

প্রশাসন রুট:

Oraal gebruik

অনুমোদন তারিখ:

1900-01-01

তথ্য লিফলেট

PACKAGE LEAFLET: INFORMATION FOR THE USER
LAPATINIB STADA
ARZNEIMITTEL AG 250 MG, FILMOMHULDE TABLETTEN
lapatinib
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. Don’t pass it on to
others. It may harm them,
even if their signs of illness seem 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 Lapatinib STADA Arzneimittel AG is and what it is used for
2.
What you need to know before you take Lapatinib STADA Arzneimittel AG
3.
How to take Lapatinib STADA Arzneimittel AG
4.
Possible side effects
5.
How to store Lapatinib STADA Arzneimittel AG
6.
Contents of the pack and other information
1.
WHAT LAPATINIB STADA ARZNEIMITTEL AG IS AND WHAT IT IS USED FOR
Lapatinib STADA Arzneimittel AG is used to treat certain types of
breast cancer _(HER2-_
_overexpressing) _
which have spread beyond the original tumour or to other organs (
_advanced _
or
_metastatic _
breast cancer). It may slow or stop cancer cells from growing, or may
kill them.
Lapatinib STADA Arzneimittel AG is prescribed to be taken in
combination with another
anti-cancer medicine.
Lapatinib STADA Arzneimittel AG is prescribed in
COMBINATION WITH CAPECITABINE
, for patients
who have had treatment for advanced or metastatic breast cancer
before. This previous treatment for
metastatic breast cancer must have included trastuzumab.
Lapatinib STADA Arzneimittel AG is prescribed in
COMBINATION WITH TRASTUZUMAB
, for patients
who have hormone receptor- negative metastatic breast cancer and have
had other treatment for
advanced or metastatic breast cancer before.
Lapatinib STADA Arzneimittel AG is prescribed in
COMBINATION WITH AN AROMATASE
INHIBITOR
, for patients with

পণ্য বৈশিষ্ট্য

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lapatinib STADA Arzneimittel AG 250 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains lapatinib ditosylate monohydrate,
equivalent to 250 mg lapatinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Oval, biconvex, off-white film-coated tablets debossed with “250”
on one side and plain on the
other, with dimensions of 16.6 mm x 8.3 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lapatinib STADA Arzneimittel AG is indicated for the treatment of
adult patients with breast
cancer, whose tumours overexpress HER2 (ErbB2);
•
in combination with capecitabine for patients with advanced or
metastatic disease with
progression following prior therapy, which must have included
anthracyclines and taxanes
and therapy with trastuzumab in the metastatic setting (see section
5.1).
•
in combination with trastuzumab for patients with hormone
receptor-negative metastatic
disease that has progressed on prior trastuzumab therapy(ies) in
combination with
chemotherapy (see section 5.1).
•
in combination with an aromatase inhibitor for postmenopausal women
with hormone
receptor positive metastatic disease, not currently intended for
chemotherapy. The patients in
the registration study were not previously treated with trastuzumab or
an aromatase inhibitor
(see sections 4.4. and 5.1). No data are available on the efficacy of
this combination relative to
trastuzumab in combination with an aromatase inhibitor in this patient
population.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lapatinib STADA Arzneimittel AG treatment should only be initiated by
a physician
experienced in the administration of anti-cancer medicinal products.
HER2 (ErbB2) overexpressing tumours are defined by IHC3+, or IHC2+
with gene amplification or
gene amplification alone. HER2 status should be determined using
accurate and validated methods.
Posology
_Lapatinib STADA Arzn