Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
capecitabine, Quantity: 500 mg
Dr Reddys Laboratories Australia Pty Ltd
Capecitabine
Tablet, film coated
Excipient Ingredients: lactose; magnesium stearate; microcrystalline cellulose; hypromellose; croscarmellose sodium; titanium dioxide; purified talc; iron oxide yellow; iron oxide red
Oral
In blister packs of 120
(S4) Prescription Only Medicine
Colon Cancer ,Capecitabine is indicated for the adjuvant treatment of patients with Dukes? stage C and high-risk 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: Peach film-coated tablet of biconvex, oblong shape with the marking 500 on one side and RDY on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-06-24
1 Capecitabine‐DRLA CAPECITABINE-DRLA _FILM-COATED TABLETS_ pronounced cap-eh-SITE-ah-bean _contains the active ingredient capecitabine_ _ _ CONSUMER MEDICINE INFORMATION such as chemotherapy • swelling of the face, lips, WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Capecitabine-DRLA 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 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 Capecitabine-DRLA contains the active ingredient capecitabine. Capecitabine-DRLA belongs to a group of medicines called anti- neoplastic agents. Within this group, Capecitabine-DRLA belongs to a class of medicines called fluoropyrimidine analogues. Capecitabine-DRLA 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, medicines. The medicine contained in Capecitabine-DRLA 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 Capecitabine-DRLA for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS WHY CAPECITABINE-DRLA HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Capecitabine-DRLA is not addictive. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE _ _IT_ DO NOT TAKE CAPECITABINE- DRLA 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 FLUO Pročitajte cijeli dokument
AUSTRALIAN PRODUCT INFORMATION – CAPECITABINE-DRLA (CAPECITABINE) TABLETS 1 NAME OF THE MEDICINE Capecitabine 2 AND 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL FORM Capecitabine tablets are supplied as biconvex oblong film-coated tablets for oral administration. Each light peach coloured tablet contains 150 mg capecitabine and each peach coloured tablet contains 500 mg capecitabine. Excipients with known effect: lactose. For the full list of excipients, see Section 6.1 List of excipients. 150 mg: Light peach film-coated tablet of biconvex, oblong shape with the marking “150” on one side and “RDY” on other side. 500 mg: Peach, film-coated tablet of biconvex, oblong shape with the marking “500” on one side and “RDY” on the other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS COLON CANCER Capecitabine-DRLA tablets are indicated for the adjuvant treatment of patients with Dukes’ stage C and high-risk stage B, colon cancer, either as monotherapy or in combination with oxaliplatin. COLORECTAL CANCER Capecitabine-DRLA tablets are indicated for the treatment of patients with advanced or metastatic colorectal cancer. OESOPHAGOGASTRIC CANCER Capecitabine-DRLA tablets are indicated for the first-line treatment of patients with advanced oesophagogastric cancer in combination with a platinum-based regimen. BREAST CANCER Capecitabine-DRLA tablets are 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-DRLA tablets in combination with docetaxel are indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy. 1 4.2 D OSE AND METHOD OF ADMINISTRATION STANDARD DOSAGE Capecitabine tablets should be swallowed with water within 30 minutes after the end of a meal. _Monotherapy - Colon, co Pročitajte cijeli dokument