国家: 以色列
语言: 英文
来源: Ministry of Health
SORAFENIB AS TOSYLATE
BAYER ISRAEL LTD
L01XE05
FILM COATED TABLETS
SORAFENIB AS TOSYLATE 200 MG
PER OS
Required
BAYER HEALTHCARE MANUFACTURING S.R.L, ITALY
SORAFENIB
SORAFENIB
Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma. Treatment of patients with hepatocellular carcinoma.Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
2013-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 The medicine is dispensed with a doctor’s prescription only NEXAVAR ® Film coated Tablets Each tablet contains: sorafenib (as tosylate) 200 mg Inactive and allergenic ingredients: see section 6 ”Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1( WHAT IS THE MEDICINE INTENDED FOR? Nexavar is intended to treat: Patients with advanced renal cell carcinoma Patients with hepatocellular carcinoma Patients with differentiated thyroid carcinoma THERAPEUTIC GROUP: Nexavar belongs to a group of medicines called multikinase inhibitors and works by slowing the growth rate of cancerous cells and stopping the blood supply that enables cancerous cells to grow. 2( BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to sorafenib or to any of the additional ingredients contained in the medicine. For the list of inactive ingredients, see section 6 ”Further Information”. • You are breastfeeding. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Talk to your doctor or pharmacist before taking Nexavar. BEFORE TREATMENT WITH NEXAVAR, TELL YOUR DOCTOR IF: • YOU EXPERIENCE SKIN PROBLEMS. Nexavar may 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 it altogether. • YOU HAVE HIGH BLOOD PRESSURE. Nexavar may increase blood pressure and your doctor will usually monitor your blood pressure and may prescribe you a medicine to treat your high blood pressure. • YOU HAVE OR HAVE HAD AN ANEURYSM )ENLARGEMENT AND WEAKENING OF A BLOOD VESSEL WALL( OR A TEAR I 阅读完整的文件
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