Pays: Pays-Bas
Langue: néerlandais
Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SORAFENIBTOSYLAAT 548 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 400 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
SORAFENIBTOSYLAAT 548 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 400 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; TITAANDIOXIDE (E 171)
Oraal gebruik
1900-01-01
Sandoz B.V. Page 1/8 Sorafenib 400 mg, filmomhulde tabletten RVG 126770 1313-v3 1.3.1.3 Bijsluiter April 2022 1 BIJSLUITER: INFORMATIE VOOR DE PATIËNT SORAFENIB SANDOZ 400 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. Whatis and what it is used for 2. What you need to know before you take Lire le document complet3. 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 stop
Sandoz B.V. Page 1/17 Sorafenib 400 mg, filmomhulde tabletten RVG 126770 V2 1.3.1.1 Samenvatting van de Productkenmerken April 2022 1 1. NAAM VAN HET GENEESMIDDEL Sorafenib Sandoz 400 mg, filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of sorafenib (as tosylate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White – off white, oval shaped, film-coated tablets, with break line on one side and plain on the other side with dimensions 20.1 mm x 10.1 mm ± 5%. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hepatocellular carcinomais indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinoma Lire le document completis 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 treatment should be supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of in adults is 400 mg sorafenib (one tablet of 400 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. Page 2/17 Sorafenib 400 mg, filmomhulde tabletten RVG 126770 V2 1.3.1.1 Samenvatting van de Productkenmerken April 2022 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 dose should be reduced to 400 mg sorafenib once daily (see section 4.4). _Paediatric population _ The safety and efficacy of <