Sorafenib Bluefish 200 mg Filmdragerad tablett

Land: Schweden

Sprache: Schwedisch

Quelle: Läkemedelsverket (Medical Products Agency)

Wirkstoff:

sorafenibtosilat

Verfügbar ab:

Bluefish Pharmaceuticals AB

ATC-Code:

L01EX02

INN (Internationale Bezeichnung):

sorafenibtosilat

Dosierung:

200 mg

Darreichungsform:

Filmdragerad tablett

Zusammensetzung:

sorafenibtosilat 274 mg Aktiv substans; natriumlaurilsulfat Hjälpämne

Verschreibungstyp:

Receptbelagt

Produktbesonderheiten:

Förpacknings: Blister, 112 tabletter

Berechtigungsstatus:

Godkänd

Berechtigungsdatum:

2022-08-24

Gebrauchsinformation

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SORAFENIB BLUEFISH 200 MG FILM-COATED TABLETS
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sorafenib Bluefish is and what it is used for
2.
What you need to know before you take Sorafenib Bluefish
3.
How to take Sorafenib Bluefish
4.
Possible side effects
5.
How to store Sorafenib Bluefish
6.
Contents of the pack and other information
1.
WHAT SORAFENIB BLUEFISH IS AND WHAT IT IS USED FOR
Sorafenib Bluefish is used to treat liver cancer (
_hepatocellular carcinoma_
).
Sorafenib Bluefish 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 Bluefish 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 BLUEFISH
DO NOT TAKE SORAFENIB BLUEFISH
-
If you are allergic to sorafenib or any of the other ingredients of
Sorafenib Bluefish (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Sorafenib Bluefish.
TAKE SPECIAL CARE WITH SORAFENIB BLUEFISH
-
IF YOU EXPERIENCE SKIN PROBLEMS.
Sorafenib Bluefish 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

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib Bluefish 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sorafenib tosilate equivalent to 200
mg sorafenib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Red, round, biconvex, film-coated tablets with a nominal diameter of
11.1 mm, debossed with
“S” on one side and plain on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hepatocellular carcinoma
Sorafenib Bluefish is indicated for the treatment of hepatocellular
carcinoma (see section 5.1).
Renal cell carcinoma
Sorafenib Bluefish 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 Bluefish treatment should be supervised by a physician
experienced in the use of anticancer
therapies.
Posology
The recommended dose of Sorafenib Bluefish 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 Sorafenib Bluefish 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 Bluefish in children and
adolescents aged < 18 years have not yet
been established. No data are available.
3
_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 with mild, moderate o