Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
SORAFENIB AS TOSYLATE
BAYER ISRAEL LTD
L01XE05
FILM COATED TABLETS
SORAFENIB AS TOSYLATE 200 MG
PER OS
Required
BAYER AG., GERMANY
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.
2023-02-28
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 Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT Nexavar 200 mg film-coated tablets 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, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma. Hepatocellular Carcinoma Nexavar is indicated for the treatment of patients with hepatocellular carcinoma (see section 5.1). Differentiated thyroid 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies. Posology The recommended dose of Nexavar 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 Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4). When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the 2 Nexavar dose should be reduced to 600 mg sorafenib daily in divided doses (two tablets of 200 mg and one tablet of 200 mg twelve hours apart). If additional dose reduction is necessary, Nexavar may be reduced to 400 mg sorafenib daily in divided doses (t Pročitajte cijeli dokument