Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DEXRAZOXANE
Novartis Pharmaceuticals UK Ltd
500mg/vial Milligram
Pdr/Conc/Soln for Infus
2006-09-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cardioxane 500mg Powder for Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cardioxane contains 500 mg lyophilized dexrazoxane, as its hydrochloric salt. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for Concentrate for Solution for Infusion. Sterile, pyrogen-free, white to off-white, lyophilized powder for solution for infusion. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic adult breast cancer patients who have received a prior cumulative dose of 300 mg/m2 of doxorubicin or a prior cumulative dose of 540 mg/m2 of epirubicin when further anthracycline treatment is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Cardioxane is administered by a short intravenous infusion (15 minutes), approximately 30 minutes prior to anthracycline administration at a dose equal to 10 times the doxorubicin-equivalent dose and 10 times the epirubicin- equivalent dose. Thus it is recommended that Cardioxane is given at a dose of 500 mg/m 2 when the commonly used dosage schedule for doxorubicin of 50 mg/m 2 is employed or 600 mg/m 2 when the commonly used dosage schedule for epirubicin of 60 mg/m 2 is employed. _Paediatric population_ Cardioxane is contraindicated in children and adolescents up to 18 years of age (see section 4.3). _Renal impairment_ In patients with moderate to severe renal dysfunction (creatinine clearance < 40 ml/min) the dexrazoxane dose should be reduced by 50%. _Hepatic impairment_ The dosage ratio should be kept, i.e. if the anthracycline dose is reduced the dexrazoxane dose should be reduced accordingly. Method of admini Read the complete document