Prospective, Prescription Event Monitoring (PEM) surveillance of EMROK® (Levonadifloxacin injection) &/or EMROK – O® (Levonadifloxacin tablet)

This is a prospective and multi-centric prescription event monitoring (PEM) surveillance in patients who have prescribed with either EMROK® or EMROK-O® or both.

Eligible patients will be identified by the investigator / physician based on selection criteria. All the patients must have received EMROK® or EMROK–O® in routine clinical practice at the study site.  Data would be collected from the medical records of such patients prospectively. After identification of patients for this PEM, prescribing investigator would record patient’s demographics, physical examination, Medical history and Concomitant medication, Prescribing indication and regimen for EMROK®  or EMROK–O®, adverse events associated with use of EMROK® or EMROK-O® in case record form.  .

Safety assessment would be done on the basis of adverse event encountered by the patients during the usage of EMROK® and / or EMROK - O®.  Efficacy would be determined by the investigator in terms of improvement or failure with respect to changes in the symptoms of infection pre and post EMROK therapy.

Investigator will perform global assessment for efficacy and safety of EMROK® and / or EMROK – O® at the end of study period on 5 point scale. The investigator shall provide the declaration for accuracy of the data. The observation period would be the earliest of any of following event viz. End of therapy / Lost to follow-up / Clinical success / Clinical failure. The relevant data would be updated in the case record form.