Երկիր: Ավստրալիա
Լեզու: անգլերեն
Աղբյուրը: Department of Health (Therapeutic Goods Administration)
Cabazitaxel acetone solvate; cabazitaxel; Cabazitaxel
Sanofi-Aventis Australia Pty Ltd
Medicine Registered
CABAZITAXEL WINTHROP ® 1 CABAZITAXEL WINTHROP ® _ _ _Cabazitaxel (ca-ba-zi-tax-el) _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cabazitaxel Winthrop. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you being given this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR DOCTOR. Keep this leaflet in a safe place as you may need to read it again. WHAT CABAZITAXEL WINTHROP IS USED FOR The name of your medicine is Cabazitaxel Winthrop. It belongs to a group of medicines called 'taxanes' used to treat cancers. Cabazitaxel Winthrop is used to treat prostate cancer that has progressed after having had other chemotherapy. It works by stopping cells from growing and multiplying. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. There is no evidence that this medicine is addictive. BEFORE YOU ARE GIVEN CABAZITAXEL WINTHROP DO NOT RECEIVE CABAZITAXEL WINTHROP IF: the number of your white blood cells is too low (neutrophil counts≤ 1,500/mm3, or less - your doctor will advise you on this), you have a liver disease you are pregnant or breast- feeding you have recently received or are about to receive a vaccine against yellow fever. DO NOT RECEIVE CABAZITAXEL WINTHROP IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, Կարդացեք ամբողջական փաստաթուղթը
Cabazitaxel Winthrop-ccdsv03-pv3-29may13 _ _ _Page 1 _ PRODUCT INFORMATION CABAZITAXEL WINTHROP ® NAME OF THE MEDICINE NON-PROPRIETARY NAME Cabazitaxel CHEMICAL STRUCTURE The chemical structure of cabazitaxel is: , O O O HO O O O O O H O OH NH O O O O DESCRIPTION Cabazitaxel belongs to the taxanes class. It is prepared by semi synthesis with a precursor extracted from yew needles. Chemical name of cabazitaxel is (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3- [(tertbutoxycarbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo- 5,20-epoxytax-11-en-2-yl benzoate - propan-2-one (1:1). Cabazitaxel is a white to off-white powder with a molecular formula of C 45 H 57 NO 14 ,C 3 H 6 O and a molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the solvent free). It is lipophilic, practically insoluble in water and soluble in alcohol. Cabazitaxel Winthrop (cabazitaxel) 60 mg/1.5 mL concentrate is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution and is available in single-use vials containing 60 mg (1.5 mL) cabazitaxel and 1.56 mg polysorbate 80. Each mL of concentrate contains 40 mg cabazitaxel (anhydrous), 1.04 mg polysorbate 80 and citric acid. Diluent for Cabazitaxel Winthrop is a clear, colourless, sterile, and non-pyrogenic, solution containing 13% (w/w) ethanol in water for injection, 4.5 mL. PHARMACOLOGY CLASS Antineoplastic agent ATC code: L01CD04 SITE AND MODE OF ACTION Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. Cabazitaxel binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly. This leads to the stabilisation of microtubules, which results in the inhibition of mitotic and interphase cellular functions. PHARMACODYNAMICS Cabazitaxel demonstrated a broad spectrum of an Կարդացեք ամբողջական փաստաթուղթը