FENESA 200 mg filmomhulde tabletten

国: オランダ

言語: オランダ語

ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

有効成分:

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

から入手可能:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

INN（国際名）:

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

医薬品形態:

Filmomhulde tablet

構図:

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)

投与経路:

Oraal gebruik

承認日:

1900-01-01

情報リーフレット

03/2022 PRAC
25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FENESA 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 FENESA is and what it is used for
2. What you need to know before you take FENESA
3. How to take FENESA
4. Possible side effects
5. How to store FENESA
6. Contents of the pack and other information
1.
WHAT FENESA IS AND WHAT IT IS USED FOR
FENESA is used to treat liver cancer
_(hepatocellular carcinoma)._
FENESA 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.
FENESA 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 FENESA
DO NOT TAKE
FENESA
–
IF YOU ARE ALLERGIC
to sorafenib or any of the other ingredients of this medicine
(listed in section 6).
03/2022 PRAC
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WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking FENESA
TAKE SPECIAL CARE WITH FENESA
–
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
treatment of cancer that are caused by the break-down products of
dying cance

製品の特徴

03/2022 PRAC
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
FENESA 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
FENESA is indicated for the treatment of hepatocellular carcinoma (see
section 5.1).
Renal cell carcinoma
FENESA 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
FENESA treatment should be supervised by a physician experienced in
the use of
anticancer therapies.
03/2022 PRAC
2
Posology
The recommended dose of FENESA 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
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 FENESA dose should
be reduced
to two tablets of 200 mg sorafenib once daily (see section 4.4).
_Paediatric population _
The safety and efficacy of FENESA in children and adolescents aged <
18 years have
not yet been established. No data are available.
_Elderly _
No dose adjustment is required in the elderly (patients above 65 years
of age).
_Renal impairment _
No dose adjustment is required in patients with mild, moderate or
severe renal
impairment. No data is available in patients req