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AssigneeRedHill Biopharma Ltd.
InventorsReza Fathi, Gilead Raday, Patricia Anderson, Elliot Offman
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A fixed-dose combination drug product formulated for oral delivery comprises a fixed 158.3 mg dose of clarithromycin, a fixed 13.3 mg dose of clofazimine and a fixed 40.0 mg dose of rifabutin. The fixed-dose combination drug product is sufficiently designed for use in treating pulmonary Mycobacterium avium Complex (MAC) disease in a subject in need thereof. A method for treating MAC disease in a human having MAC lung infection comprising orally administering, twice daily, about 475 mg of clarithromycin, about 40 mg of clofazimine and about 120 mg of rifabutin. A kit for treating pulmonary MAC disease in an individual having MAC lung infection comprises a supply of fixed-dose combination drug products, wherein each of the fixed-dose combination drug products comprise a fixed 158.3 mg dose of clarithromycin, a fixed 13.3 mg dose of clofazimine and a fixed 40.0 mg dose of rifabutin; and instructions for use.
A fixed-dose combination drug product formulated for oral delivery, the drug product comprising a fixed 158.3 milligram (mg) dose of clarithromycin, a fixed 13.3 milligram (mg) dose of clofazimine and a fixed 40.0 milligram (mg) dose of rifabutin.
A method for treating pulmonary Mycobacterium avium Complex (MAC) disease in a human having MAC lung infection, the method comprising orally administering, once daily, about 475 milligram (mg) of clarithromycin, about 40 milligram (mg) of clofazimine and about 120 milligram (mg) of rifabutin.
A method for treating pulmonary Mycobacterium avium Complex (MAC) disease in a human having MAC lung infection, the method comprising orally administering, twice daily, about 475 milligram (mg) of clarithromycin, about 40 milligram (mg) of clofazimine and about 120 milligram (mg) of rifabutin.
A method for treating pulmonary Mycobacterium avium Complex (MAC) disease in a patient having MAC lung infection, the method comprising orally administering to the patient at least three fixed-dose combination drug products, wherein each drug product comprises a fixed 158.3 milligram (mg) dose of clarithromycin, a fixed 13.3 milligram (mg) dose of clofazimine and a fixed 40 milligram (mg) dose of rifabutin, and wherein the administering occurs only on Monday-Wednesday-Friday for a period of time of at least six (6) months.
A kit for treating pulmonary Mycobacterium avium Complex (MAC) disease in an individual having MAC lung infection comprising:
Dependencies are inferred from the claim text.