Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
oxaliplatin, Quantity: 100 mg
Wockhardt Bio Pty Ltd
Oxaliplatin
Injection, concentrated
Excipient Ingredients: water for injections; nitrogen
Intravenous Infusion
1 vial
(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: Clear, colorless solution containing 5 mg/ml Oxaliplatin.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-10-13
OXALIPLATIN WKT ( _Oxaliplatin_ ) CONSUMER MEDICINE INFORMATION other staff will take all of the aware of WHAT IS IN THIS LEAFLET precautions needed to reduce the • you are taking any other unwanted effects of treatment. This leaflet answers some common medicines, including medicines that you have bought without a questions about Oxaliplatin injection. It does not contain all the available information. Oxaliplatin WKT is only available on a prescription from your doctor. prescription from a pharmacy, supermarket or health food shop. Your doctor or pharmacist can tell you It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of using Oxaliplatin WKT against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. WHAT OXALIPLATIN WKT IS USED FOR Oxaliplatin WKT is used to treat cancer of the oesophagus/stomach, large intestine and rectum (colorectal cancer). Oxaliplatin WKT is used in combination with other anti-cancer drugs; capecitabine, bevacizumab, epirubicin, fluorouracil (FU), and/or folinic acid. The active ingredient in Oxaliplatin WKT is called oxaliplatin. Cancer cells are normal cells which have changed so that they grow in an uncontrolled way. Oxaliplatin works by interfering with cancer cell growth. BEFORE YOU ARE GIVEN OXALIPLATIN WKT _WHEN YOU MUST NOT RECEIVE IT _ YOU SHOULD NOT BE GIVEN OXALIPLATIN WKT IF YOU ARE ALLERGIC TO THE ACTIVE INGREDIENT 'OXALIPLATIN'. If you have had an allergic reaction to oxaliplatin before, you should not receive it again. YOU MUST NOT RECEIVE OXALIPLATIN WKT IF YOU ARE PREGNANT OR BREASTFEEDING. Oxaliplatin may cause birth defects if you are being treated with it at the time of conception or it is given to women who are already pregnant. Adequate contraception is required during treatment with oxaliplatin. You should discuss this with your doctor. Nursing mothers are advised not to breastfeed while receiving Lesen Sie das vollständige Dokument
OXALIPLATIN WKT V2.3 Version 2.3 Page 1 of 38 AUSTRALIAN PRODUCT INFORMATION – OXALIPLATIN WKT (OXILAPLATIN) CONCENTRATED INJECTION FOR INTRAVENOUS INFUSION 1 NAME OF THE MEDICINE Oxilaplatin 2 QUALITATIVE AND QUANTITATIVE COMPOSITION OXALIPLATIN WKT is available as a concentrated solution for infusion in 50mg/10mL and 100mg/20mL vials Oxaliplatin is a white to off-white crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and practically insoluble in ethanol. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Concentrated injection for intravenous infusion in a clear glass vial 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC 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 D OSE AND METHOD OF ADMINISTRATION 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 OXALIPLATIN WKT V2.3 Version 2.3 Page 2 of 38 1 of a three week cycle. For the recommended doses of capecitabine (see Section 5.1 PHARMACODYNAMIC PROPERTIES ). In combination with fluorouracil and folinic acid for the treatment of advanced colorectal cancer, the recommended dose of oxaliplatin is 85mg/m 2 intravenously re Lesen Sie das vollständige Dokument