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ALINIA ® OS Head-to-Head Data8ALINIA efficacy vs. metronidazole in pediatric patients with Giardia lamblia 13 :ALINIA for Oral Suspension (OS), 100 mg/5 mLClinical Response Rates a (% “Well”)Nitazoxanide (3 days treatment) 90% (43/48)95%}Per Protocol b CI DiffMetronidazole (5 days treatment) 83% (39/47)-8%, 21%0% 20% 40% 60% 80% 100%Randomized, controlled study of 110 pediatric patients treated with ALINIA for Oral Suspension aaALINIA for Oral Suspension 100 mg BID (24-47 months) and 200 mg BID (ages 4-11 years) x 3 days, was compared to metronidazole 125 mg BID (ages2-5 years) and 250 mg BID (ages 6-11 years) x 5 days; clinical response evaluated 7-10 days after treatment initiationbPer protocol analysis includes only patients who took all of their medication and completed the study. Seven patients in each treatment group missed atleast 1 dose of medication and 1 in the metronidazole treatment group was lost to follow-up*IndicationsALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for thetreatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.Important Safety Information• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivityto nitazoxanide or any other ingredient in the formulations.
ALINIA ® Tablets Efficacy9ALINIA Tablets, 500 mg, demonstrated efficacy against diarrhea caused byCryptosporidium parvum and Giardia lamblia 13Pathogen andStudy NumberClinical Response Rate (% “Well”)Alinia Tablets (n)Placebo Control (n)Cryptosporidium 1 96% (28) 41% (27)Cryptosporidium 2 71% (21) 43% (21)Giardia 1 85% (54) 44% (27)Giardia 2 100% (8) 30% (10)*IndicationsALINIA ® for Oral Suspension (patients 1 year of age and older) and ALINIA Tablets (patients 12 years and older)are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum.Limitations of Use: ALINIA for Oral Suspension and ALINIA Tablets have not been shown to be effective for thetreatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients.Important Safety Information• ALINIA Tablets and ALINIA for Oral Suspension are contraindicated in patients with a prior hypersensitivityto nitazoxanide or any other ingredient in the formulations.
Page 1 and 2: When diarrhea persists more than 14
Page 3 and 4: AGA Clinical Guidelines3In 2019 gui
Page 5 and 6: About Giardiasis5In the U.S., Giard
Page 7: ALINIA ® Tablets Clinical Study De
Page 11 and 12: ALINIA ® OS Head-to-Head Data11ALI
Page 13 and 14: ALINIA ® Safety Profile13Most Comm
Page 15 and 16: ALINIA ® Patient Savings15With the

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