Rebyota

(Donor Human Stool)

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Dosage & Administration

For rectal administration only.

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Rebyota Prescribing Information

Do not administer REBYOTA to individuals with a history of a severe allergic reaction (e.g. anaphylaxis) to any of the known product components

[see

11 DESCRIPTION

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 1×10⁸and 5×10¹⁰colony forming units (CFU) per mL of fecal microbes including >1×10⁵CFU/mL of

Bacteroides

, and contains not greater than 5.97 grams of PEG3350 in saline.

]

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Rebyota

Dosage & Administration

Rebyota Prescribing Information

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