国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
letrozole, Quantity: 2.5 mg
Cipla Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; sodium starch glycollate; microcrystalline cellulose; hypromellose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; iron oxide yellow; macrogol 400
Oral
10, 30
(S4) Prescription Only Medicine
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.
Visual Identification: Yellow circular, biconvex, film coated tablet debossed with LT on one side and 2.5 on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2018-12-17
LETROZOLE APOTEX 1 LETROZOLE APOTEX _Letrozole _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR The name of your medicine is Letrozole APOTEX. It contains the active ingredient letrozole. Letrozole 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. 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- dependant." Reducing the production of oestrogen may help keep the cancer from growing. This may be the first time you are taking an "anti-oestrogen”, or you may have taken another "anti- oestrogen" such as tamoxifen in the past. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. THERE IS NOT ENOUGH INFORMATION TO RECOMMEND THE USE OF LETROZOLE IN CHILDREN. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing letrozole • any of the ingredients listed at the end of this leaflet. Some of the symptoms 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION LETROZOLE APOTEX (LETROZOLE) TABLETS 1 NAME OF THE MEDICINE Letrozole. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION LETROZOLE APOTEX is available as coated tablets containing 2.5 mg letrozole. EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Tablet containing 2.5mg letrozole: yellow, circular, biconvex film-coated tablets debossed with LT on one side and 2.5 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of postmenopausal women with hormone receptor positive breast cancer (see section 5.1 PHARMACODYNAMIC 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 METHOD OF ADMINISTRATION Letrozole tablets should be taken orally. A missed dose should be taken as soon as the patient remembers. However, if it is almost time for the next dose, the missed dose should be skipped, and the patient should go back to her regular dosage schedule. Doses should not be doubled because with daily doses over the 2.5 mg recommended dose, over-proportionality in systemic exposure was observed. DOSAGE ADULTS The recommended dose of letrozole tablets is one 2.5 mg 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 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. 2 In the adjuvant setting the median duration of treatment was 25 mon 阅读完整的文件