Sorafenib Sandoz 200 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemščina

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

Aktivna sestavina:

SORAFENIBTOSYLAAT SAMENSTELLING overeenkomend met ; SORAFENIB

Dostopno od:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

INN (mednarodno ime):

SORAFENIBTOSYLAAT COMPOSITION corresponding to ; SORAFENIB

Farmacevtska oblika:

Filmomhulde tablet

Sestava:

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)

Pot uporabe:

Oraal gebruik

Datum dovoljenje:

2020-06-27

Navodilo za uporabo

Sandoz B.V.
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Sorafenib 200 mg, filmomhulde tabletten
RVG 124974
1313-V2
1.3.1.3 Bijsluiter
Februari 2021
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB 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 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 SKIN PROBLEMS.
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 sto

Lastnosti izdelka

Sandoz B.V.
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Sorafenib 200 mg, filmomhulde tabletten
RVG 124974
V1
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2020
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib Sandoz 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 Sandoz is indicated for the treatment of hepatocellular
carcinoma (see section 5.1).
Renal cell carcinoma
Sorafenib Sandoz 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 Sandoz treatment should be supervised by a physician
experienced in the use of
anticancer therapies.
Posology
The recommended dose of Sorafenib Sandoz 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
Sandoz B.V.
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Sorafenib 200 mg, filmomhulde tabletten
RVG 124974
V1
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2020
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 Sandoz 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 Sandoz in children and
adolescen