SPL Set ID: a4e28b09-714b-46e7-b4e6-0163cad78fc5

Moxifloxacin is a synthetic broad spectrum antibacterial agent for intravenous administration. Moxifloxacin, a fluoroquinolone, is available as a buffered monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6- fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance. Its chemical structure is as follows: Moxifloxacin Injection is sterile solution for infusion in a ready-to-use, single-dose flexible bag. Chemical Structure Moxifloxacin Injection * 400 mg moxifloxacin equivalent to 437.5 mg of moxifloxacin hydrochloride. **The pH may have been adjusted with sulfuric acid. The pH is 5.0 to 6.0. Component Function Dosage Formulation Moxifloxacin* Active ingredient 400 mg* Sodium acetate (added as a trihydrate) Tonicity adjuster 1,702.5 mg Disodium sulfate Tonicity adjuster 2,840 mg Sulfuric acid ** pH adjustment As needed Water for injection vehicle q.s. 250 mL Each mL contains 1.6 mg of moxifloxacin. The appearance of the intravenous solution is clear. The flexible bag is fabricated from a specially designed multilayer plastic (freeflex ® ). Solution is in contact with the polypropylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The leachable compounds were all within acceptable limits based on animal toxicology studies. Moxifloxacin Injection contains approximately 52.5 mEq (1,207 mg) of sodium in 250 mL.