País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LETROZOL 2,5 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
L02BG04
LETROZOL 2,5 mg/stuk
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Letrozole
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 8000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2010-11-02
Sandoz B.V. Page 1/6 Letrozol Sandoz tablet 2,5 mg tablet 2,5 mg RVG 106322 1313-v11 1.3.1.3 Bijsluiter Juli 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LETROZOL SANDOZ ® 2,5 MG, FILMOMHULDE TABLETTEN letrozol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1 What [Nationally completed name] is and what it is used for 2 What you need to know before you take [Nationally completed name] 3 How to take [Nationally completed name] 4 Possible side effects 5 How to store [Nationally completed name] 6 Contents of the pack and other information 1 WHAT [NATIONALLY APPROVED NAME] IS AND WHAT IT IS USED FOR WHAT [NATIONALLY APPROVED NAME] IS AND HOW IT WORKS [Nationally approved name] contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) breast cancer treatment. Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones. [Nationally approved name] reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow. As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body. WHAT [NATIONALLY APPROVED NAME] IS USED FOR [Nationally approved name] is used to treat breast cancer in women who have gone through menopause i.e. cessation of periods. It is used to prevent cancer from happening again. It can be used as first treatme Leia o documento completo
Sandoz B.V. Page 1/24 Letrozol Sandoz tablet 2,5 mg RVG 106322 1311-V9 1.3.1.1 Samenvatting van de Productkenmerken Oktober 2019 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Letrozol Sandoz 2,5 mg, filmomhulde tabletten 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 2.5 mg letrozole. Excipients(s) with known effect Each film-coated tablet contains 58.4 mg of lactose (as lactose monohydrate) and up to 0.21 mg (0.009 mmol) sodium (as sodium starch glycolate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 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 invasive early breast cancer. Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years. First-line treatment in postmenopausal women with hormone_-_dependent advanced breast cancer. Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens. Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated. Efficacy has not been demonstrated in patients with hormone receptor negative breast cancer. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sandoz B.V. Page 2/24 Letrozol Sandoz tablet 2,5 mg RVG 106322 1311-V9 1.3.1.1 Samenvatting van de Productkenmerken Oktober 2019 Posology _Adult and elderly patients_ The recommended dose of [Nationally approved name] is 2.5 mg once daily. No dose adjustment is required for elderly patients. In patients with advanced or metastatic breast cancer, treatment wi Leia o documento completo