Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
letrozole, Quantity: 2.5 mg
Aspen Pharma Pty Ltd
Letrozole
Tablet, film coated
Excipient Ingredients: magnesium stearate; hypromellose; colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate; titanium dioxide; iron oxide yellow; macrogol 400
Oral
30 tablets
(S4) Prescription Only Medicine
Treatment of postmenopausal women with hormone receptor positive breast cancer (See Clinical Trials).,The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.
Visual Identification: Round, yellow, biconvex, film-coated tablet; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2011-09-23
FERA- Consumer Medicine Information Page 1 of 3 FERA letrozole CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FERA. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking FERA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT FERA IS USED FOR FERA 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. FERA 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" or you may have taken another "antioestrogen" such as tamoxifen in the past. Your doctor may have prescribed FERA for another reason. Ask your doctor if you have any questions about why FERA has been prescribed for you. FERA is available only with a doctor's prescription. BEFORE YOU TAKE FERA WHEN YOU MUST NOT TAKE IT DO NOT TAKE FERA IF YOU ARE ALLERGIC TO MEDICINES CONTAINING LETROZOLE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath. DO NOT TAKE FERA IF YOU ARE STILL HAVING PERIODS. This medicine is only used in women who are no longer having periods. WOMEN OF CHILD-BEARING AGE Läs hela dokumentet
FERA- Product Information Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION - FERA (LETROZOLE) 1. NAME OF THE MEDICINE Letrozole 2. QUALITATIVE AND QUATITATIVE COMPOSIITION Fera tablets contain 2.5 mg of letrozole. The tablets also contain lactose, sodium starch glycollate, cellulose - microcrystalline, hypromellose, silica - colloidal anhydrous, magnesium stearate and Opadry Yellow 03B52094 (ID No. 106949). The tablets are gluten free. For full list of excipients, see Section 6.1 List of excipients. 3.PHARMACEUTICAL FORM Yellow, round, biconvex tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of postmenopausal women with hormone receptor positive breast cancer (see CLINICAL TRIALS). The safety and efficacy of neoadjuvant use of letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended dose of letrozole is one tablet daily. In the adjuvant setting, treatment should continue for five years or until tumour relapse occurs, whichever comes first. In the extended adjuvant setting, the optimal treatment duration with letrozole is not known. The planned duration of treatment in the pivotal study was five years. However, at the time of the analysis, the median duration of treatment was 24 months, 25% of patients were treated for at least three years and less than 1% of patients were treated for the planned five years. The median duration of follow-up was 28 months. Treatment should be discontinued at tumour relapse. In the adjuvant setting the median duration of treatment was 25 months, 73% of the patients were treated for more than two years, 22% of the patients for more than four years. The median duration of follow-up was 30 months (the efficacy data mentioned in CLINICAL TRIALS are based on the primary core analysis with a median duration of follow-up of 26 months). In patients with metastatic disease, treatment with letrozole should continue until tumour progression is evident. ELDERLY PATIEN Läs hela dokumentet