Sorafenib Zentiva 200 mg, filmomhulde tabletten

Ország: Hollandia

Nyelv: holland

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

Aktív összetevők:

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

Beszerezhető a:

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

INN (nemzetközi neve):

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

Gyógyszerészeti forma:

Filmomhulde tablet

Összetétel:

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)

Az alkalmazás módja:

Oraal gebruik

Engedély dátuma:

1900-01-01

Betegtájékoztató

Sorafenib NL-H-4878-001
03/2022 PRAC
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SORAFENIB ZENTIVA 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 Zentiva is and what it is used for
2. What you need to know before you take Sorafenib Zentiva
3. How to take Sorafenib Zentiva
4. Possible side effects
5. How to store Sorafenib Zentiva
6. Contents of the pack and other information
1.
WHAT SORAFENIB ZENTIVA IS AND WHAT IT IS USED FOR
Sorafenib Zentiva is used to treat liver cancer
_(hepatocellular carcinoma)._
Sorafenib Zentiva 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 Zentiva 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 ZENTIVA
DO NOT TAKE
SORAFENIB ZENTIVA
–
IF YOU ARE ALLERGIC
to sorafenib or any of the other ingredients of this medicine
(listed in section 6).
Sorafenib NL-H-4878-001
03/2022 PRAC
25
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Sorafenib Zentiva .
TAKE SPECIAL CARE WITH SORAFENIB ZENTIVA
–
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, SEIZU

Termékjellemzők

Sorafenib NL-H-4878-001
03/2022 PRAC
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAAM VAN HET GENEESMIDDEL
Sorafenib Zentiva 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 Zentiva is indicated for the treatment of hepatocellular
carcinoma (see
section 5.1).
Renal cell carcinoma
Sorafenib Zentiva 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 Zentiva treatment should be supervised by a physician
experienced in the use
of anticancer therapies.
Sorafenib NL-H-4878-001
03/2022 PRAC
2
Posology
The recommended dose of Sorafenib Zentiva 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 Zentiva
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 Zentiva 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 _
N