Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
letrozole
Juno Pharmaceuticals Pty Ltd
Letrozole
Registered
_Letrozole AN tablets – Consumer Medicine Information _ _ _ _Letrozole AN CMI v3.0 _ _ _ _ _ _Page 1 _ LETROZOLE AN TABLETS _Letrozole tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Letrozole AN. 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 Letrozole AN 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 LETROZOLE AN IS USED FOR Letrozole AN is used for the treatment of breast cancer in post-menopausal women i.e. women who no longer have periods, either because of their natural age or following surgery or chemotherapy Letrozole belongs to a family of medicines called aromatase inhibitors (also referred to as antioestrogens). They function by decreasing the amount of the hormone oestrogen that is produced in your body. The growth of certain types of breast cancer is promoted by oestrogen. These cancers are known as “oestrogen-dependent”. Decreasing the production of oestrogen may aid to prevent the cancer from growing. This might be the first time you are taking an "antioestrogen" such as Letrozole AN or you might have taken another "antioestrogen" such as tamoxifen in the past. If you have any questions about why Letrozole AN has been prescribed for you, ask your doctor. You may have been prescribed Letrozole AN by your doctor for another reason. Letrozole AN is only obtainable with a doctor’s prescription. Letrozole AN is not addictive. BEFORE YOU TAKE LETROZOLE AN _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE LETROZOLE AN IF YOU ARE ALLERGIC TO: • Letrozole, the active ingredient in this medicine • Any of the other ingredients of this medicine listed at the end of this leaflet. If you get an allergic reaction, sym Przeczytaj cały dokument
Australian Product Information Letrozole AN PI v3.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION LETROZOLE AN _(LETROZOLE) _ _ _ 1 NAME OF THE MEDICINE Letrozole 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Letrozole AN tablet contains letrozole 2.5 mg. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Letrozole AN is presented as yellow, round, biconvex, film-coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of postmenopausal women with hormone receptor positive breast cancer (see section 5.1 Pharmacodynamics properties – 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 AN is one tablet daily. In the adjuvant setting, treatment should continue for 5 years or until tumour relapse occurs, whichever comes first. In the extended adjuvant setting, the optimal treatment duration with Letrozole AN is not known, the planned duration of treatment in the pivotal study was 5 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 5 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 2 years, 22% of the patients for more than 4 years. The median duration of follow up was 30 months (the efficacy data mentioned in section 5.1 Pharmacodynamics properties – 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 AN should continue until tumour progression is evident. Australian Product Information Letrozole AN Przeczytaj cały dokument