Weldinin 200 mg, filmomhulde tabletten

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

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

INN (Nama Internasional):

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

Bentuk farmasi:

Filmomhulde tablet

Komposisi:

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)

Rute administrasi :

Oraal gebruik

Tanggal Otorisasi:

2021-11-17

Selebaran informasi

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

Karakteristik produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Weldinin 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
Weldinin is indicated for the treatment of hepatocellular carcinoma
(see section 5.1).
Renal cell carcinoma
Weldinin 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
Weldinin treatment should be supervised by a physician experienced in
the use of anticancer
therapies.
Posology
The recommended dose of Weldinin 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.
2
When dose reduction is necessary during the treatment of
hepatocellular carcinoma (HCC)
and advanced renal cell carcinoma (RCC), the Weldinin dose should be
reduced to two tablets
of 200 mg sorafenib once daily (see section 4.4).
_Paediatric population _
The safety and efficacy of Weldinin 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 with mild, moderate or
severe renal impairment.
No data is available in patient