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1 Indications And Usage Impavido (Miltefosine) Capsules Are Indicated In Adults And Adolescents ≥12 Years Of Age Weighing ≥ 30 Kg For The Treatment Of: • Visceral Leishmaniasis Caused By Leishmania Donovani [See Clinical Trials ( 14.1 )] . • Cutaneous Leishmaniasis Caused By Leishmania Braziliensis , Leishmania Guyanensis , And Leishmania Panamensis [See Clinical Trials ( 14.2 )] . • Mucosal Leishmaniasis Caused By Leishmania Braziliensis [See Clinical Trials ( 14.3 )] . Limitations Of Use: • Leishmania Species Studied In Clinical Trials Evaluating Impavido Were Based On Epidemiologic Data [See Clinical Trials ( 14.1 , 14.2 )] . • There May Be Geographic Variation In Clinical Response Of The Same Leishmania Species To Impavido [See Clinical Trials ( 14.1 , 14.2 )] . • The Efficacy Of Impavido In The Treatment Of Other Leishmania Species Has Not Been Evaluated. Impavido Is An Antileishmanial Drug Indicated In Adults And Adolescents ≥12 Years Of Age Weighing ≥30 Kg (66 Lbs) For Treatment Of: • Visceral Leishmaniasis Due To Leishmania Donovani ( 1 ). • Cutaneous Leishmaniasis Due To Leishmania Braziliensis, Leishmania Guyanensis, And Leishmania Panamensis ( 1 ). • Mucosal Leishmaniasis Due To Leishmania Braziliensis ( 1 ). Limitations Of Use : Leishmania Species Evaluated In Clinical Trials Were Based On Epidemiologic Data. There May Be Geographic Variation In The Response Of The Same Leishmania Species To Impavido ( 1 , 14 ). The Efficacy Of Impavido In The Treatment Of Other Leishmania Species Has Not Been Evaluated.
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