Sorafenib STADApharm 200 mg, filmomhulde tabletten

Country: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

SORAFENIBTOSYLAAT SAMENSTELLING overeenkomend met ; SORAFENIB

Disponibbli minn:

STADApharm GmbH Stadastrasse 2 - 18 61118 BAD VILBEL (DUITSLAND)

INN (Isem Internazzjonali):

SORAFENIBTOSYLAAT COMPOSITION corresponding to ; SORAFENIB

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLYETHYLEENGLYCOL (E 1521) ; TITAANDIOXIDE (E 171)

Rotta amministrattiva:

Oraal gebruik

Data ta 'l-awtorizzazzjoni:

2020-06-17

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB STADAPHARM 200 MG, FILMOMHULDE TABLETTEN
sorafenib
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 Sorafenib STADApharm is and what it is used for
2.
What you need to know before you take Sorafenib STADApharm
3.
How to take Sorafenib STADApharm
4.
Possible side effects
5.
How to store Sorafenib STADApharm
6.
Contents of the pack and other information
1.
WHAT SORAFENIB STADAPHARM IS AND WHAT IT IS USED FOR
Sorafenib STADApharm is used to treat liver cancer
_(hepatocellular carcinoma)._
Sorafenib STADApharm is also used to treat kidney cancer
_(advanced renal cell carcinoma)_
at an advanced stage when standard therapy has not helped to stop your
disease or is
considered unsuitable.
Sorafenib STADApharm is a so-called
_multikinase inhibitor_
. It works by slowing down the
rate of growth of cancer cells and cutting off the blood supply that
keeps cancer cells
growing.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SORAFENIB STADAPHARM
DO NOT TAKE
SORAFENIB STADAPHARM
-
IF YOU ARE ALLERGIC
to sorafenib or any of the other ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Sorafenib STADApharm
TAKE SPECIAL CARE WITH SORAFENIB STADAPHARM
-
IF YOU EXPERIENCE SKIN PROBLEMS.
Sorafenib STADApharm can cause rashes and
skin reactions, especially on the hands and feet. These can usually be
treated by your
doctor. If not, your doctor may interrupt treatment or stop it
altogether.
-
IF YO

Karatteristiċi tal-prodott

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib STADApharm 200 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Red-brown, round, biconvex film-coated tablets, debossed with
“200” on one side and plain
on the other side with a diameter of tablet 12.0 mm ± 5%.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepatocellular carcinoma
Sorafenib STADApharm is indicated for the treatment of hepatocellular
carcinoma (see
section 5.1).
Renal cell carcinoma
Sorafenib STADApharm is indicated for the treatment of patients with
advanced renal cell
carcinoma who have failed prior interferon-alpha or interleukin-2
based therapy or are
considered unsuitable for such therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sorafenib STADApharm treatment should be supervised by a physician
experienced in the use
of anticancer therapies.
Posology
The recommended dose of Sorafenib STADApharm in adults is 400 mg
sorafenib (two tablets
of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Treatment should continue as long as clinical benefit is observed or
until unacceptable toxicity
occurs.
Posology adjustments
2
Management of suspected adverse drug reactions may require temporary
interruption or dose
reduction of sorafenib therapy.
When dose reduction is necessary during the treatment of
hepatocellular carcinoma (HCC)
and advanced renal cell carcinoma (RCC), the Sorafenib STADApharm dose
should be
reduced to two tablets of 200 mg sorafenib once daily (see section
4.4).
_Paediatric population _
The safety and efficacy of Sorafenib STADApharm in children and
adolescents aged < 18
years have not yet been established. No data are available.
_Elderly population _
No dose adjustment is required in the elderly (patients above 65 years
of age).
_Renal impairment _
No dose adjustment is required in patie