Sorafenib betapharm 200 mg, filmomhulde tabletten

Land: Nederland

Språk: nederlandsk

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

Aktiv ingrediens:

SORAFENIBTOSYLAAT 274 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 200 mg/stuk

Tilgjengelig fra:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

INN (International Name):

SORAFENIBTOSYLAAT 274 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 200 mg/stuk

Legemiddelform:

Filmomhulde tablet

Sammensetning:

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

Administreringsrute:

Oraal gebruik

Autorisasjon dato:

1900-01-01

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB BETAPHARM 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 betapharm is and what it is used for
2.
What you need to know before you take Sorafenib betapharm
3.
How to take Sorafenib betapharm
4.
Possible side effects
5.
How to store Sorafenib betapharm
6.
Contents of the pack and other information
1.
WHAT SORAFENIB BETAPHARM IS AND WHAT IT IS USED FOR
Sorafenib betapharm is used to treat liver cancer
_(hepatocellular carcinoma)._
Sorafenib betapharm 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 betapharm 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 BETAPHARM
DO NOT TAKE
SORAFENIB BETAPHARM
-
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 betapharm
TAKE SPECIAL CARE WITH SORAFENIB BETAPHARM
-
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 grou

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib betapharm 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 betapharm is indicated for the treatment of hepatocellular
carcinoma (see section
5.1).
Renal cell carcinoma
Sorafenib betapharm 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 betapharm treatment should be supervised by a physician
experienced in the use of
anticancer therapies.
Posology
The recommended dose of Sorafenib betapharm 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 betapharm 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 betapharm 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 patients wit