국가: 이스라엘
언어: 영어
출처: Ministry of Health
LENVATINIB AS MESILATE
EISAI ISRAEL LTD., ISRAEL
L01XE29
HARD CAPSULE
LENVATINIB AS MESILATE 4 MG
PER OS
Required
EISAI MANUFACTURING LIMITED, UK
LENVATINIB
LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).LENVIMA is indicated in combination with everolimus for the treatment of adult patients with advanced clear cell renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy.Lenvima, in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation.LENVIMA is indicated in combination with pembrolizumab for the first-line treatment of adult patients with advanced RCC.
2021-01-31
PHARMA CODE READ DIRECTION 2006197 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is to be supplied upon a physician's prescription only LENVIMA® 4 MG HARD CAPSULES COMPOSITION: THE ACTIVE INGREDIENT AND ITS QUANTITY: Each hard capsule contains: Lenvatinib (as mesilate) 4 mg LENVIMA® 10 MG HARD CAPSULES COMPOSITION: THE ACTIVE INGREDIENT AND ITS QUANTITY: Each hard capsule contains: Lenvatinib (as mesilate) 10 mg For list of excipients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the physician or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if you think that their illness is similar to yours. This medicine is not intended for use in children and adolescents under 18 years of age. The effects of LENVIMA in people younger than 18 years old are unknown. Treatment with LENVIMA should be initiaited and supervised by a physician experienced in the use of anticancer therapies. 1. WHAT IS THE MEDICINE INTENDED FOR? - For the treatment of advanced thyroid cancer in adults when radioactive iodine treatment has not helped to stop the disease. - In combination with everolimus, for the treatment of advanced clear cell kidney cancer in adults when other treatments [called "targeted therapy VEGF (Vascular endothelial growth factor)”] have not helped stop the disease. - As monotherapy for the treatment of liver cancer (hepatocellular carcinoma) in adults who have not previously been treated with systemic therapy with another anticancer medicine. People get LENVIMA when their liver cancer has spread or cannot be taken out by surgery. - In combination with pembrolizumab to treat advanced or recurrent cancer of the lining of the uterus (endometrial carcinoma) in adults whose cancer has spread while or after being previously treated with 전체 문서 읽기
1. NAME OF THE MEDICINAL PRODUCT LENVIMA ® 4 MG LENVIMA ® 10 MG hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION LENVIMA ® 4 mg: Each hard capsule contains 4 mg of lenvatinib (as mesylate). LENVIMA ® 10 mg: Each hard capsule contains 10 mg of lenvatinib (as mesylate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. LENVIMA ® 4 mg: A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body. Diameter 5.3mm, length 14.3 LENVIMA ® 10 mg: A yellow body and yellowish-red cap, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body. Diameter 5.3mm, length 14.3, 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LENVIMA is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI). LENVIMA is indicated in combination with everolimus for the treatment of adult patients with advanced clear cell renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy. LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy. Lenvima, in combination with pembrolizumab, is indicated for the treatment of adult patients with advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum containing therapy and who are not candidates for curative surgery or radiation. LENVIMA is indicated in combination with pembrolizumab for the first-line treatment of adult patients with advanced RCC. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION LENVIMA treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies. If a patient misses a dose, and it cannot be t 전체 문서 읽기