Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
capecitabine, Quantity: 150 mg
Viatris Pty Ltd
Tablet, film coated
Excipient Ingredients: hypromellose; magnesium stearate; iron oxide yellow; microcrystalline cellulose; lactose; purified talc; titanium dioxide; iron oxide red; croscarmellose sodium; purified water
Oral
120 Tablets in blister pack, 30 Tablets in blister pack, 60 Tablets in blister pack
(S4) Prescription Only Medicine
Colon Cancer:,Capecitabine is indicated for the adjuvant treatment of patients with Duke?s stage C and highrisk stage B, colon cancer, either as monotherapy or in combination with oxaliplatin.,Colorectal Cancer:,Capecitabine is indicated for the treatment of patients with advanced or metastatic colorectal cancer.,Oesophagogastric Cancer:,Capecitabine is indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen.,Breast Cancer:,Capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen unless therapy with these and other standard agents are clinically contraindicated.,Capecitabine in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.
Visual Identification: Light peach coloured, oblong shaped, biconvex, film-coated tablets, debossed with 150 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
XELABINE CONSUMER MEDICINE INFORMATION Version: 3.0 -2016- Page: 1 of 5 XELABINE (CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG) CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Xelabine tablets. 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 Xelabine tablets 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 XELABINE IS USED FOR Xelabine contains the active ingredient capecitabine. Xelabine belongs to a group of medicines called anti-neoplastic agents. Within this group, Xelabine belongs to a class of medicines called fluoropyrimidine analogues. Xelabine is used to treat cancer of the bowel and rectum (colorectal), breast and stomach and food pipe (oesophagus). It may be prescribed alone or in combination with other medicines used to treat cancer, such as chemotherapy medicines. The medicine contained in Xelabine tablets, capecitabine, is converted by the liver and cancer cells to another medicine called 5-fluorouracil (also called 5-FU). It is 5-FU that acts to kill or stop the growth of cancer cells. Your doctor may have prescribed Xelabine for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY XELABINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. _Xelabine is not addictive._ BEFORE YOU TAKE XELABINE WHEN YOU MUST NOT TAKE IT DO NOT TAKE XELABINE IF: 1. YOU HAVE HAD AN ALLERGY TO • CAPECITABINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET • 5-FLUOROURACIL (ALSO CALLED 5-FU), A MEDICINE USED TO TREAT CANCER • OTHER FLUOROPYRIMIDINE MEDICINES _ _ Some of the symptoms of an allergic reaction may include: _ _ • shortness of breath • wheezing or difficulty in br Perskaitykite visą dokumentą
Xelabine (Capecitabine Tablets 150 mg and 500 mg) Version 2.0 Page 1 of 34 PRODUCT INFORMATION XELABINE (CAPECITABINE FILM-COATED TABLETS 150 MG AND 500 MG) NAME OF THE MEDICINE Capecitabine (CAS Registry Number: 154361-50-9) The chemical name for capecitabine is 5’-deoxy-5-fluoro-N-[(pentyloxy)carbonyl]- cytidine with the molecular formula C 15 H 22 FN 3 O 6 and a molecular weight of 359.35. DESCRIPTION Capecitabine is an oral, antineoplastic agent belonging to the fluoropyrimidine carbamate class. It was rationally designed as an orally administered precursor of 5’-deoxy-5- fluorouridine (5’-DFUR), which is selectively activated to the cytotoxic moiety, fluorouracil, in tumours. Capecitabine is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20°C. Xelabine is supplied as oblong shaped, biconvex film-coated tablets for oral administration. Each light peach coloured tablet contains 150 mg capecitabine and each peach coloured tablet contains 500 mg capecitabine. The inactive ingredients in Xelabine are lactose anhydrous, cellulose microcrystalline, croscarmellose sodium, hypromellose, and magnesium stearate. The peach or light peach film coating contains hypromellose, purified talc, titanium dioxide and iron oxide yellow and iron oxide red. PHARMACOLOGY Capecitabine itself is non-cytotoxic; however, it is selectively activated to the cytotoxic moiety, fluorouracil (5-FU), by thymidine phosphorylase in tumours. PHARMACODYNAMICS BIOACTIVATION Capecitabine is a fluoropyrimidine carbamate derivative that was designed as an orally administered, tumour-activated and tumour-selective cytotoxic agent. Capecitabine is noncytotoxic _in vitro_ . Capecitabine is absorbed unchanged from the gastrointestinal tract, metabolised primarily in the liver by the 60 kDa carboxylesterase to 5’-deoxy-5-fluorocytidine (5’-DFCR), Xelabine (Capecitabine Tablets 150 mg and 500 mg) Version 2.0 Page 2 of 34 which is then converted to 5’-DFUR by cytidine deaminase, principally located in the liver Perskaitykite visą dokumentą