Country: Israel
Language: English
Source: Ministry of Health
LETROZOLE
NOVARTIS ISRAEL LTD
L02BG04
FILM COATED TABLETS
LETROZOLE 2.5 MG
PER OS
Required
NOVARTIS PHARMA STEIN AG, SWITZERLAND
LETROZOLE
LETROZOLE
Femara (letrozole tablets) is indicated for first-line treatment in postmenopausal women with hormone receptor positive or in whome hormone receptor status cannot be determined locally advanced or metastatic breast cancer. Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Extended adjuvant treatment of early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy. Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
2023-03-31
ﺔﻴﺻﻮﺗ ﺐﺴﺣ ﺝﻼﻌﻟﺍ ﻰﻠﻋ ﺔﺒﻇﺍﻮﻤﻟﺍ ﺐﺠﻳ .ﺐﻴﺒﻄﻟﺍ _ﺍﺭﺎﻤﻴﻓ ﻝﻭﺎﻨﺗ ﻦﻋ ﺖﻔﻗﻮﺗ ﺍﺫﺇ_ ﻥﻭﺪﺑ ﺀﺍﻭﺪﻟﺎﺑ ﺝﻼﻌﻟﺍ ﻦﻋ ﻒﻗﻮﺘﻟﺍ ﺯﻮﺠﻳ ﻻ .ﺐﻴﺒﻄﻟﺍ ﺓﺭﺎﺸﺘﺳﺇ ﺓﺮﺘﻓ" ﻩﻼــﻋﺃ ﺓﺮﻘﻔﻟﺍ ﻲﻓ ﹰ ﺎﻀﻳﺃ ﻱﺮﻈﻧﺃ "ﺝﻼﻌﻟﺍ _ ﺺﻴﺨﺸﺗ ﺐﺠﻳ !ﺔﻤﺘﻌﻟﺍ_ _ ﻲﻓ ﺔﻳﻭﺩﺃ_ _ ﻲﻟﻭﺎﻨﺘﺗ ﻻ_ _ ﺔﻴﺋﺍﻭﺪﻟﺍ ﺔﻋﺮﺠﻟﺍ ﻦﻣ ﺪﻛﺄﺘﻟﺍﻭ ﺀﺍﻭﺪﻟﺍ ﻊﺑﺎﻃ_ _ ﻲﻌﺿ .ﺀﺍﻭﺩ ﺎﻬﻴﻓ ﻦﻴﻟﻭﺎﻨﺘﺗ ﺓﺮﻣ ﻞﻛ ﻲﻓ_ _.ﻚﻟﺫ ﺮﻣﻷﺍ ﻡﺰﻟ ﺍﺫﺇ ﺔﻴﺒﻄﻟﺍ ﺕﺍﺭﺎﻈﻨﻟﺍ_ _ ﻝﻮﺣ ﺔﻴﻓﺎﺿﺇ ﺔﻠﺌﺳﺃ ﻚﻳﺪﻟ ﺕﺮﻓﻮﺗ ﺍﺫﺇ_ _ ﻭﺃ ﺐﻴﺒﻄﻟﺍ ﻱﺮﻴﺸﺘﺳﺇ ،ﺀﺍﻭﺪــﻟﺍ ﻝﺎﻤﻌﺘﺳﺇ_ _.ﻲﻟﺪﻴﺼﻟﺍ_ _ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ (4_ ﺐﺒﺴﻳ ﺪﻗ ﺍﺭﺎﻤﻴﻓ ﻝﺎﻤﻌﺘﺳﺇ ﻥﺇ ،ﺀﺍﻭﺩ ﻞﻜﺑ ﺎﻤﻛ .ﺕﻼﻤﻌﺘﺴﻤﻟﺍ ﺾﻌﺑ ﺪﻨﻋ ﺔﻴﺒﻧﺎﺟ ﹰ ﺎﺿﺍﺮﻋﺃ .ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﺔﻤﺋﺎﻗ ﻦﻣ ﻲﺸﻫﺪﻨﺗ ﻻ ﺽﺍﺮﻋﻷﺍ ﺐﻠﻏﺃ .ﺎﻬﻨﻣ ﹰ ﺎﻳﺃ ﻲﻧﺎﻌﺗ ﻻﺃ ﺰﺋﺎﺠﻟﺍ ﻦﻣ ،ﺔﻄﺳﻮﺘﻣ ﻰﺘﺣ ﺔﻔﻴﻔﺧ ﻥﻮﻜﺗ ﺔﻴﺒﻧﺎﺠﻟﺍ ﻊﻴﺑﺎﺳﺃ ﺓﺪﻋ ﻰﺘﺣ ﻡﺎﻳﺃ ﺓﺪﻋ ﺪﻌﺑ ﺓﺩﺎﻋ ﻲﻔﺘﺨﺗﻭ ﻞﺜﻣ ،ﺔﻴﺒﻧﺎﺠﻟﺍ ﺽﺍﺮﻋﻷﺍ ﻦﻣ ﻢﺴﻗ .ﺝﻼﻌﻟﺍ ﻦﻣ ﻲﻠﺒﻬﻣ ﻑﺰﻧ ﻭﺃ ﺮﻌﺸﻟﺍ ﻂﻗﺎﺴﺗ ،ﺮﺤﻟﺍ ﻦﻣ ﺕﺎﺒﻫ ﺕﺎﻨﻴﺟﻭﺮﺘﺳﻹﺍ ﺺﻘﻧ ﺔﺠﻴﺘﻧ ﺙﺪﺤﺗ ﻥﺃ ﻦﻜﻤﻳ .ﻚﻤﺴﺟ ﻲﻓ _ ﻥﻮﻜﺗ ﻥﺃ ﻦﻜﻤﻳ ﻲﺘﻟﺍ ﺔﻴﺒﻧﺎﺟ ﺽﺍﺮــﻋ Read the complete document
Page 1 of 15 FEM API OCT20 V1 REF UK SMPC APR 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Femara 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: letrozole. Each film - coated tablet contains 2.5 mg letrozole. Each tablet contains 61.5 mg of lactose monohydrate. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Film-coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the imprint “FV”, the other “CG”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. • Extended adjuvant treatment of early breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy. • First-line treatment in postmenopausal women with hormone receptor positive, or in whom the hormone receptor status cannot be determined, locally advanced or metastatic breast cancer. • Treatment of advanced breast cancer in postmenopausal women with disease progression following anti-oestrogen therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adult and elderly patients _ The recommended dose of Femara is 2.5 mg once daily. No dose adjustment is required for elderly patients. In patients with advanced or metastatic breast cancer, treatment with Femara should continue until tumour progression is evident. Page 2 of 15 FEM API OCT20 V1 REF UK SMPC APR 2020 In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until tumour relapse occurs, whichever is first. _Paediatric population _ Femara is not recommended for use in children and adolescents. The safety and efficacy of Femara in children and adolescents aged up to 17 years have not been established. Limited data are available and no recommendation on a posology can be made. _Renal Read the complete document