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|Title:||Liquid pharmaceutical formulations of palonosetron|
|Abstract:||The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.|
|Inventor(s):||Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Casalzuigno, IT), Cannella; Roberta (Varese, IT), Macciocchi; Alberto (Melide, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M (Palo Alto, CA), Panuccio; Carmine (Casnate con Bernate, IT)|
|Assignee:||HELSINN HEALTHCARE SA (CH) ROCHE PALO ALTO LLC (Palo Alto, CA)|
|Filing Date:||Nov 04, 2013|
|Claims:||1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 50 mL sterile isotonic solution buffered at a pH of 4.8.+-.0.5 comprising: palonosetron hydrochloride in an amount of 0.75 mg based on the weight of its free base; 450.0 mg sodium chloride; 2.5 mg EDTA; 18.5 mg sodium citrate; and 7.8 mg citric acid monohydrate, wherein said formulation is contained in a polyethylene multilayer film infusion bag comprising an isoprene rubber stopper.|
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