Quốc gia: Hà Lan
Ngôn ngữ: Tiếng Hà Lan
Nguồn: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
SORAFENIBTOSYLAAT 274 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 200 mg/stuk
Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)
SORAFENIBTOSYLAAT 274 mg/stuk SAMENSTELLING overeenkomend met ; SORAFENIB 200 mg/stuk
Filmomhulde tablet
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)
Oraal gebruik
1900-01-01
03/2022 PRAC 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FENESA 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 FENESA is and what it is used for 2. What you need to know before you take FENESA 3. How to take FENESA 4. Possible side effects 5. How to store FENESA 6. Contents of the pack and other information 1. WHAT FENESA IS AND WHAT IT IS USED FOR FENESA is used to treat liver cancer _(hepatocellular carcinoma)._ FENESA 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. FENESA 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 FENESA DO NOT TAKE FENESA – IF YOU ARE ALLERGIC to sorafenib or any of the other ingredients of this medicine (listed in section 6). 03/2022 PRAC 26 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking FENESA TAKE SPECIAL CARE WITH FENESA – 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 cance Đọc toàn bộ tài liệu
03/2022 PRAC 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAAM VAN HET GENEESMIDDEL FENESA 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 FENESA is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinoma FENESA 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 FENESA treatment should be supervised by a physician experienced in the use of anticancer therapies. 03/2022 PRAC 2 Posology The recommended dose of FENESA 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 FENESA dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4). _Paediatric population _ The safety and efficacy of FENESA 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 _ No dose adjustment is required in patients with mild, moderate or severe renal impairment. No data is available in patients req Đọc toàn bộ tài liệu