Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
oxaliplatin, Quantity: 100 mg
Juno Pharmaceuticals Pty Ltd
Oxaliplatin
Injection, concentrated
Excipient Ingredients: water for injections
Intravenous Infusion
1
(S4) Prescription Only Medicine
Oxaliplatin is indicated for adjuvant treatment of stage III (Duke?s C) colon cancer, in combination with fluoropyrimidine agent.,Oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer.,Oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer.,Oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for: the treatment of patients with advanced oesophagogastric cancer
Visual Identification: a sterile, colourless, clear, aqueous solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2016-05-24
Oxaliplatin Juno Concentrated Injection 1 OXALIPLATIN JUNO CONCENTRATED INJECTION SOLUTION FOR INFUSION _Contains the active ingredient oxaliplatin _ CONSUMER MEDICINE INFORMATION _ _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about oxaliplatin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up- to-date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Oxaliplatin Juno concentrated injection solution for infusion. It contains the active ingredient oxaliplatin. It is used to treat cancer of the oesophagus/stomach, large intestine and rectum (colorectal cancer). Oxaliplatin is used in combination with other anti-cancer drugs; capecitabine, bevacizumab, epirubicin, fluorouracil (FU), and/or folinic acid. Cancer cells are normal cells which have changed so that they grow in an uncontrolled way. Oxaliplatin works by interfering with cancer cell growth. Because of the similarities between cancer cells and normal cells, anti-cancer drugs often have unwanted effects on the body. Your doctors have decided to treat you with oxaliplatin because they believe that the benefit of oxaliplatin treatment will be greater than the unwanted effects. Many of the side effects from anti-cancer drugs are predictable and can be prevented or lessened. Prečítajte si celý dokument
1 AUSTRALIAN PRODUCT INFORMATION OXALIPLATIN JUNO (OXALIPLATIN) CONCENTRATED INJECTION SOLUTION FOR INFUSION 1 NAME OF THE MEDICINE Oxaliplatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of concentrated injection solution for infusion contains 50 mg/10 mL, 100 mg/20 mL or 200 mg/40 mL oxaliplatin, as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Concentrated injection solution for infusion: A sterile, colourless, clear, aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oxaliplatin is indicated for adjuvant treatment of stage III (Duke’s C) colon cancer, in combination with fluoropyrimidine agent. Oxaliplatin in combination with fluorouracil and folinic acid is indicated for the treatment of advanced colorectal cancer. Oxaliplatin in combination with capecitabine, with or without bevacizumab, is indicated for the treatment of patients with metastatic colorectal cancer. Oxaliplatin in combination with epirubicin and either capecitabine or fluorouracil, is indicated for: the treatment of patients with advanced oesophagogastric cancer. 4.2 DOSE AND METHOD OF ADMINISTRATION Oxaliplatin Juno concentrated injection solution for infusion is for intravenous infusion. DOSAGE In combination with fluorouracil and folinic acid for adjuvant treatment of colon cancer, the recommended dose of oxaliplatin is 85 mg/m 2 intravenously repeated every two weeks for 12 cycles (6 months). In combination with capecitabine for adjuvant treatment of colon cancer, the recommended dose of oxaliplatin is 130 mg/m 2 , administered as an intravenous infusion over 2 hours on day 1 of a three week cycle. For the recommended doses of capecitabine see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS. In combination with fluorouracil and folinic acid for the treatment of advanced colorectal cancer, the recommended dose of oxaliplatin is 85 mg/m 2 intravenously repeated every two weeks. In combination with capecitabine with or without bevacizumab Prečítajte si celý dokument