Sorafenib Pharmascience 200 mg, filmomhulde tabletten

Quốc gia: Hà Lan

Ngôn ngữ: Tiếng Hà Lan

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

Thành phần hoạt chất:

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

Sẵn có từ:

Pharmascience International Ltd Lampousas 1 1095 NICOSIA (CYPRUS)

INN (Tên quốc tế):

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

Dạng dược phẩm:

Filmomhulde tablet

Thành phần:

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)

Tuyến hành chính:

Oraal gebruik

Ngày ủy quyền:

2020-06-27

Tờ rơi thông tin

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

Đặc tính sản phẩm

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sorafenib Pharmascience 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 Pharmascience is indicated for the treatment of
hepatocellular carcinoma (see
section 5.1).
Renal cell carcinoma
Sorafenib Pharmascience 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 Pharmascience treatment should be supervised by a physician
experienced in the use
of anticancer therapies.
Posology
The recommended dose of Sorafenib Pharmascience 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
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 Pharmascience
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 Pharmascience 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