posfrea

11 DESCRIPTION POSFREA Injection contains palonosetron as palonosetron HCl, an antiemetic and antinauseant agent. It is a serotonin-3 (5-HT 3 ) receptor antagonist with a strong binding affinity for this receptor. Chemically, palonosetron HCl is: (3a S )-2-[ (S)- 1-Azabicyclo [2.2.2]oct 3-yl]-2,3,3a,4,5,6-hexahydro-1-oxo-1 H benz[ de ]isoquinoline hydrochloride. The empirical formula is C 19 H 24 N 2 O . HCl, with a molecular weight of 332.87. Palonosetron HCl exists as a single isomer and has the following structural formula: Palonosetron HCl is a white to off-white crystalline powder. It is freely soluble in water, soluble in propylene glycol, and slightly soluble in ethanol and 2-propanol. POSFREA Injection is a sterile, clear, colorless, non-pyrogenic, isotonic, buffered solution for intravenous administration. POSFREA Injection is available as a 5 mL or 1.5 mL single-dose vial. Each mL of aqueous solution contains 0.05 mg palonosetron (equivalent to 0.056 mg palonosetron hydrochloride). Each mL also contains 41.5 mg mannitol, 3.0 mg sodium acetate trihydrate, and water for injection (q.s. to 1.0 mL). The pH of the solution in the 5 mL and 1.5 mL vials is 4.5 to 5.5. Hydrochloric acid or sodium hydroxide may have been added to adjust pH. Image