国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Oxaliplatin 50mg
Pfizer New Zealand Limited
Oxaliplatin 50 mg
50 mg
Powder for injection
Active: Oxaliplatin 50mg Excipient: Lactose monohydrate
Vial, glass, Type I clear glass, 1 vial, 1 dose unit
Prescription
Prescription
Heraeus Deutschland GmbH & Co. KG
DBL™ Oxaliplatin, in combination with 5-fluorouracil and folinic acid, is indicated for: · Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour. · Treatment of advanced colorectal cancer.
Package - Contents - Shelf Life: Vial, glass, Type I clear glass, 1 vial - 1 dose units - 36 months from date of manufacture stored at or below 30°C. (below 30°C)
2009-01-09
Version: pfdoxalv10520 Supersedes: pfdoxalvp10120 Page 1 of 25 NEW ZEALAND DATA SHEET 1. PRODUCT NAME_ _ DBL ™ Oxaliplatin for Injection 20 mg Powder for injection DBL ™ Oxaliplatin for Injection 50 mg Powder for injection DBL ™ Oxaliplatin for Injection 100 mg Powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of DBL Oxaliplatin for Injection (oxaliplatin powder for injection) contains either 20 mg, 50 mg or 100 mg oxaliplatin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM DBL Oxaliplatin for Injection is a sterile lyophilised powder for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS DBL Oxaliplatin, in combination with 5-fluorouracil and folinic acid, is indicated for: • Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of the primary tumour. • Treatment of advanced colorectal cancer. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE In combination with fluorouracil and folinic acid the recommended dose for the treatment of advanced colorectal cancer is either 85 mg/m 2 intravenously repeated every two weeks. In combination with fluorouracil and folinic acid the recommended dose for adjuvant treatment is 85 mg/m 2 intravenously repeated every two weeks for 12 cycles (6 months). DOSE ADJUSTMENTS Prior to each treatment cycle, patients should be evaluated for toxicity and the dose of oxaliplatin adjusted accordingly. Version: pfdoxalv10520 Supersedes: pfdoxalvp10120 Page 2 of 25 _NEUROLOGICAL TOXICITY _ If acute neurological reactions occur, e.g., acute pharyngolaryngeal dysaesthesia, increase the oxaliplatin infusion time from 2 hours to 6 hours. This decreases C max by 30% and may lessen acute toxicities. If sensory loss or paraesthesia persists longer than 7 days or interferes with function (grade 2 toxicity), reduce oxaliplatin dose by 25%. If sensory loss or paraesthesia interferes with activities of daily living (grade 3 toxicity), oxaliplatin should be discontinued. _HAEMATOLOGICAL TOXICITY _ If haematologic 阅读完整的文件