Health Condition 1: B35-B49- Mycoses
Conditions
Interventions
Intervention1: Amphonex® (Liposomal Amphotericin B for Injection): As per the prescribing information
daily dose of 1 mg/kg bodyweight increase gradually to 3 mg/kg
Route - intravenous
Control Interv
Sponsors
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of either gender = 18 years of age. Subjects who are prescribed Liposomal Amphotericin B or have started Liposomal Amphotericin B (Amphonex®) treatment as per Investigator’s discretion for current illness. Subjects/LAR willing and able to give written informed consent according to applicable regulatory requirements.
Exclusion criteria
Exclusion criteria: History of anaphylactic or other severe systemic reaction to Lipid-based amphotericin b or any of its excipients. Subjects suffering from any medical condition that in the investigator’s opinion could compromise the subject’s ability to participate in the clinical study. Subject participating prospectively in another clinical study within the last four weeks before the enrolment to the study. In the last six weeks Subject have taken any amphotericin B preparation other than Amphonex®. Subjects on therapy with Nephrotoxic drugs including but not limited to aminoglycosides, cyclosporine, polymyxin B and tacrolimus. Pregnant or nursing females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidences of Serious adverse events (SAEs) and adverse events (AEs) which are (serious/non-serious, expected/unexpected, related to the study drug) reported during the study.Timepoint: Throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with adverse eventsTimepoint: Throughout the study;Percentage of subjects with treatment discontinuation due to study drug-related adverse eventsTimepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Ramesh Jagannathan
Bharat serums and Vaccines LTd
Outcome results
None listed