দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
REGORAFENIB
BAYER ISRAEL LTD
L01XE21
FILM COATED TABLETS
REGORAFENIB 40 MG
PER OS
Required
BAYER AG., GERMANY
REGORAFENIB
REGORAFENIB
Stivarga is indicated as monotherapy for the treatment of adults patients:- with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy,and if KRAS wild- type, an anti-EGFR therapy.- with locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.- hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
2018-10-31
STIVARGA ® FILM-COATED TABLETS PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only Each tablet contains: Regorafenib 40 mg Inactive ingredients and allergens in the preparation: see section 6 “Further Information” and also see section 2 “Important information regarding some of the ingredients of the medicine”. READ THIS 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 for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Stivarga contains the active ingredient regorafenib and is intended for the treatment of cancer. The medicine acts by slowing the growth and spread of cancer cells and cutting off the blood supply that allows cancer cells to continue growing. Stivarga is intended for treatment of the following conditions: - colon or rectal cancer that has spread to other parts of the body in patients who have been treated in the past with fluoropyrimidine-, oxaliplatin- and irinotecan- based chemotherapy, who have been treated in the past with an anti-VEGF therapy and, in the case of KRAS-wild-type, have been treated in the past with an anti-EGFR therapy. - gastrointestinal stromal tumor (GIST), which is a certain type of cancer of the stomach and bowel that is not amenable to surgery or has spread to other parts of the body, in patients who have been treated in the past with other anti-cancer medicines (imatinib and sunitinib). - liver cancer (hepatocellular carcinoma - HCC) in patients who have been treated in the past with another anti-cancer medicine (sorafenib). THERAPEUTIC GROUP: Stivarga belongs to the group of anti-cancer medicines called protein kinase inhibitors. Protein kinase is a group of enzymes respons সম্পূর্ণ নথি পড়ুন
1 1. NAME OF THE MEDICINAL PRODUCT Stivarga 40 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg of regorafenib. Excipients with known effect: Each daily dose of 160 mg contains 2.438 mmol (or 56.06 mg) of sodium (see section 4.4). Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ Film-coated tablet. Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER’ on one side and ‘40’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Stivarga is indicated as monotherapy for the treatment of adult patients with: -metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy and if KRAS wild-type, an anti-EGFR therapy . - locally advanced, unresectable or metastatic gastrointestinal stromal tumors (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. - hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy. Posology The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy. This 4-week period is considered a treatment cycle. _ _ If a dose is missed, then it should be taken on the same day as soon as the patient remembers. The patient should not take two doses on the same day to make up for a missed dose. In case of vomiting after regorafenib administration, the patient should not take additional tablets. Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4). Patients with performance status (PS) 2 or higher were excluded from clinical studies. There সম্পূর্ণ নথি পড়ুন