Χώρα: Νέα Ζηλανδία
Γλώσσα: Αγγλικά
Πηγή: Medsafe (Medicines Safety Authority)
Letrozole 2.5mg;
Novartis New Zealand Ltd
Letrozole 2.5 mg
2.5 mg
Film coated tablet
Active: Letrozole 2.5mg Excipient: Colloidal silicon dioxide Hypromellose As 0.087 mg Pigment suspension white + 0.087 mg Pigment suspension yellow + 1.663 mg additional Iron oxide yellow Lactose monohydrate Macrogols Magnesium stearate Maize starch Microcrystalline cellulose Purified talc Sodium starch glycolate Titanium dioxide
Blister pack, physicians sample, 15 tablets
Prescription
Prescription
Novartis Pharma Schweizerhalle AG
Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer Extended adjuvant treatment of invasive early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy for five years. First-line treatment in postmenopausal women with 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.
Package - Contents - Shelf Life: Blister pack, physicians sample - 15 tablets - 60 months from date of manufacture stored at or below 30°C - Blister pack, - 30 tablets - 60 months from date of manufacture stored at or below 30°C
1996-05-14
FEMARA ® 2.5MG TABLETS LETROZOLE WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Femara. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Femara against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FEMARA IS USED FOR Femara is used to treat breast cancer in women who are post-menopausal - that is, women who no longer have periods, either naturally due to their age or after surgery or chemotherapy. Femara is available in tablets containing 2.5 mg of the active ingredient, letrozole. Letrozole belongs to a family of medicines called aromatase inhibitors. They are also called "antioestrogens" because they act by reducing the production of oestrogen in your body. Oestrogen stimulates the growth of certain types of breast cancer. These cancers are called "oestrogen-dependent." Reducing the production of oestrogen may help to keep the cancer from growing. This may be the first time you are taking an "antioestrogen" such as Femara or you may have taken another "antioestrogen" such as tamoxifen in the past. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY FEMARA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Femara for another reason. Femara is only available with a doctor's prescription. It is not addictive. BEFORE YOU TAKE FEMARA _WHEN YOU MUST NOT USE IT _ DO NOT TAKE FEMARA IF YOU HAVE AN ALLERGY TO: • letrozole, the active ingredient in Femara • any other ingredients of Femara listed at the end of this leaflet Some of the symptoms of an allergic reaction may include rash, itching or hives on the Διαβάστε το πλήρες έγγραφο
NEW ZEALAND DATA SHEET FEMARA ® LETROZOLE 2.5 MG FILM-COATED TABLETS. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablets. Coated tablet, dark yellow, round, slightly biconvex with bevelled edges. One side bears the imprint “FV”, the other “CG”. Active substance: 4,4'-[(1H-1,2,4-triazol-1-yl)-methylene]bis-benzonitrile (INN/USAN= letrozole). Each film-coated tablet contains 2.5 mg letrozole. For a full list of excipients, see List of excipients. LIST OF EXCIPIENTS Colloidal anhydrous silica, microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch, sodium starch glycollate, hydroxypropyl methylcellulose, polyethylene glycol 8000, talc, titanium dioxide (E 171), iron oxide yellow (E 172). INDICATIONS Letrozole is not indicated in hormone receptor negative disease. Letrozole is indicated in: Adjuvant treatment of postmenopausal women with hormone receptor positive invasive early breast cancer. Extended adjuvant treatment of invasive early breast cancer in post menopausal women who have received prior standard adjuvant tamoxifen therapy for five years. First-line treatment in postmenopausal women with 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. DOSAGE AND ADMINISTRATION DOSAGE GENERAL TARGET POPULATION ADULTS The recommended dose of Femara ® is 2.5 mg once daily. In the adjuvant and extended adjuvant setting, treatment with Femara should continue for 5 years or until disease relapse/recurrence occurs, whichever comes first. In the large pivotal study of letrozole versus tamoxifen in the adjuvant setting, no benefit in efficacy or safety was obtained by sequential administration of these treatments compared with letrozole administered continuously for 5 years. In patients with me Διαβάστε το πλήρες έγγραφο