Transcription of XOFLUZA Prescribing Information - Genentech
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XOFLUZA Prescribing Information - Genentech
HIGHLIGHTS OF Prescribing Information Refer to the Full Prescribing Information for Information on recommended These highlights do not include all the Information needed to use dosage of XOFLUZA oral suspension in adults and adolescents (12 years of XOFLUZA safely and effectively. See full Prescribing Information for age and older). ( ). XOFLUZA . Refer to the Full Prescribing Information for additional Information on XOFLUZA (baloxavir marboxil) tablets, for oral use preparation of XOFLUZA for oral suspension for oral or enteral use. ( ). XOFLUZA (baloxavir marboxil) for oral suspension Initial Approval: 2018 ---------------------DOSAGE FORMS AND STRENGTHS---------------------- Tablets: 40 mg and 80 mg. (3). -----------------------------RECENT MAJOR CHANGES------------------------- For oral suspension: 40 mg/20 mL when constituted for final concentration Indications and Usage of 2 mg/mL.
XOFLUZA 80 mg tablets are white to light yellow, oblong shaped, film-coated tablets debossed with “BXM80” on one side. XOFLUZA for Oral Suspension: XOFLUZA for oral suspensioncontains 40 mg/20mL or 2 mg/mLbaloxavir marboxil after constitution with 20 mL of drinking water or sterile water. The granules are white to light yellow.
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