Sorafenib STADA Arzneimittel 400 mg, filmomhulde tabletten

País: Países Bajos

Idioma: neerlandés

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

Ingredientes activos:

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

Disponible desde:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

Designación común internacional (DCI):

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

formulario farmacéutico:

Filmomhulde tablet

Composición:

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

Vía de administración:

Oraal gebruik

Fecha de autorización:

1900-01-01

Información para el usuario

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB STADA ARZNEIMITTEL 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 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 used to treat liver cancer
_(hepatocellular carcinoma)._
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.
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
DO NOT TAKE

-
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
TAKE SPECIAL CARE WITH
-
IF YOU EXPERIENCE THE FOLLOWING SYMPTOMS, CONTACT YOUR DOCTOR
IMMEDIATELY AS THIS
CAN
BE
A
LIFE-THREATENING
CONDITION:
NAUSEA,
SHORTNESS
OF
BREATH,
IRREGULAR
HEARTBEAT, MUSCULAR CRAMPS, SEIZURE, CLOUDING OF URINE AND TIREDNESS
. These may
be caused by a group of metabolic complications that can occur during

Ficha técnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib STADA Arzneimittel 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
is indicated for the treatment of hepatocellular
carcinoma (see section 5.1).
Renal cell carcinoma
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
treatment should be supervised by a physician
experienced in the use of
anticancer therapies.
Posology
The recommended dose of 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 dose
should be reduced to 400
mg sorafenib once daily (see section 4.4).
_Paediatric population _
The safety and efficacy of 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).