SPL Set ID: 7af8a7f6-a441-4dc6-a151-138a89166fbb
1 drug(s) with this SPL Set ID
REBYOTA (fecal microbiota, live – jslm) is an opaque fecal microbiota suspension for rectal administration. REBYOTA is manufactured from human fecal matter sourced from qualified donors. The human fecal matter is tested for a panel of transmissible pathogens. Donors do not have dietary restrictions with respect to potential food allergens. The fecal microbiota suspension is the filtrate generated by processing the fecal matter in a pre-defined ratio with a solution of polyethylene glycol (PEG) 3350 and saline. Each 150mL dose of REBYOTA contains between 1×10 8 and 5×10 10 colony forming units (CFU) per mL of fecal microbes including >1×10 5 CFU/mL of Bacteroides , and contains not greater than 5.97 grams of PEG3350 in saline.