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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
11/25/2014
Trade Name:
Priftin
Generic Name or Proper Name (*):
rifapentine
Indications Studied:
Treatment of latent tuberculosis infection (LTBI) caused by Mycobacterium tuberculosis in combination with isoniazid (INH)
Label Changes Summary:
*At the time of approval, the safety and effectiveness of PRIFTIN in combination with isoniazid (INH) once-weekly regimen for the treatment of LTBI was established *A study of 742 pediatric patients (2-17 years of age) compared the effectiveness of 12 weekly doses of PRIFTIN in combination with INH (3RPT/INH arm) administered by directly observed therapy to 9 months of self-administered daily INH (9INH arm) *The safety profile in children in clinical studies was similar to that observed in adults *Weight based dosage recommendations for treatment of LTBI
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Sanofi Aventis
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