देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LETROZOLE
FRESENIUS KABI MALAYSIA SDN. BHD
LETROZOLE
28 mcg/mL; 30 Tablet Tablets; 28 Tablet Tablets
Fresenius Kabi Oncology Limited
Consumer Medication Information Leaflet (RiMUP) 1 TROZET Letrozole Tablets USP 2.5 mg WHAT IS IN THIS LEAFLET 1. What TROZET is and what it is used for 2. How does TROZET works 3. What you need to know before you take TROZET 4. How to take TROZET 5. While you are using TROZET 6. Possible side effects 7. How to store and dispose TROZET 8. Product Description 1. WHAT TROZET IS AND WHAT IT IS USED FOR? TROZET 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. TROZET is used to treat breast cancer in women who are post- menopausal – thatis, women who no longer have periods, either naturally due to their age or after surgery or chemotherapy. It is also used before surgery in postmenopausal breast cancer women. 2. HOW TROZET WORKS? Growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Femara reduces the amount of estrogen by blocking an enzyme (“aromatase”) involved in the production of estrogens and therefore, may block the growth of breast cancers that need estrogen to grow. As a consequence, tumor cells slow or stop the progression and/or spreading to other parts of the body. 3. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TROZET? Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. _- When you must not use it _ • If you are allergic (hypersensitive) to letrozole or to any of the ingredients in Trozet listed in this leaflet. If you think you may be allergic, ask your doctor for advice. • If you still have periods, i.e. if you have not yet gone through the menopause. • If you are pregnant. • If you are breast-feeding If any of these conditions apply to you, tell your doctor before taking Trozet. _PREGNANCY_ You must not take Trozet if you are pregnant as it may harm your unborn baby. Your doctor will discuss with you the potential risks of taking Trozet during pregnancy. There are report पूरा दस्तावेज़ पढ़ें
Page 1 of 7 For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory LETROZOLE TABLETS USP 2.5 MG TROZET DESCRIPTION: Letrozole tablets USP for oral administration contains 2.5 mg of letrozole USP, a nonsteroidal aromatase inhibitor (inhibitor of estrogen synthesis). Letrozole is a white to yellowish crystalline powder, freely soluble in dichloromethane, slightly soluble in alcohol, sparingly soluble in methanol, and practically insoluble in water. Letrozole tablets USP is available as 2.5 mg tablets for oral administration. It is yellow, circular, biconvex film coated tablets, debossing with “DB03” on one side and plain on other side. COMPOSITION: Each Film Coated Tablet contains Letrozole USP 2.5 mg _Colour_ : Yellow Iron Oxide and Titanium Dioxide CHEMICAL STRUCTURE: It is chemically described as 4,4'-(1H-1, 2,4- Triazol-1-ylmethylene) dibenzonitrile, and its structural formula is: It has a molecular weight of 285.31, empirical formula C17H11N5, and a melting range of 184°C-185°C. PHARMACOLOGY: PHARMACODYNAMICS The growth of some cancers of the breast is stimulated or maintained by estrogens. In postmenopausal women, oestrogens are mainly derived from the action of the aromatase enzyme, which convert the adrenal androgens – primarily androstenedione and testosterone - to oestrone (E1) and oestradiol (E2). The suppression of oestrogen biosynthesis in peripheral tissue and the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme. Letrozole is a non-steroidal aromatase inhibitor. It inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of enzyme Page 2 of 7 resulting in a reduction of oestrogen biosynthesis in all tissues. In healthy postmenopausal women, single doses of 0.1mg, 0.5mg and 2.5 mg letrozole suppress serum oestrone and oestradiol by 75 to 78% and 78% from baseline, respectively. Maximum suppression is achieved in 48 to 78 hours. In postmenopausal patient, with advanced breast cance पूरा दस्तावेज़ पढ़ें