Sorafenib G.L. 400 mg, filmomhulde tabletten

Country: Холандија

Језик: Холандски

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

Активни састојак:

SORAFENIBTOSYLAAT 548 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 400 mg/stuk

Доступно од:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

INN (Међународно име):

SORAFENIBTOSYLAAT 548 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 400 mg/stuk

Фармацеутски облик:

Filmomhulde tablet

Састав:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)

Пут администрације:

Oraal gebruik

Датум одобрења:

1900-01-01

Информативни летак

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB G.L. 400 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 G.L. is and what it is used for
2.
What you need to know before you take Sorafenib G.L.
3.
How to take Sorafenib G.L.
4.
Possible side effects
5.
How to store Sorafenib G.L.
6.
Contents of the pack and other information
1.
WHAT SORAFENIB G.L. IS AND WHAT IT IS USED FOR
Sorafenib G.L. is used to treat liver cancer
_(hepatocellular carcinoma)._
Sorafenib G.L. 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 G.L. 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 G.L.
DO NOT TAKE
SORAFENIB G.L.
-
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 G.L.
TAKE SPECIAL CARE WITH SORAFENIB G.L.
-
IF YOU EXPERIENCE SKIN PROBLEMS.
Sorafenib G.L. 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 YOU HAVE HIGH BLOOD PRESSURE.
Sorafenib G.L. can raise blood pressure, and your
doctor

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib G.L. 400 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg of sorafenib (as tosylate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White – off white, oval shaped, film-coated tablets, with break line
on one side and plain on the
other side with dimensions 20.1 mm x 10.1 mm ± 5%.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepatocellular carcinoma
Sorafenib G.L. is indicated for the treatment of hepatocellular
carcinoma (see section 5.1).
Renal cell carcinoma
Sorafenib G.L. 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 G.L. treatment should be supervised by a physician
experienced in the use of
anticancer therapies.
Posology
The recommended dose of Sorafenib G.L. in adults is 400 mg sorafenib
(one tablet of 400 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 G.L. dose should be
reduced to 400 mg
sorafenib once daily (see section 4.4).
_Paediatric population _
The safety and efficacy of Sorafenib G.L. 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 impair