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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:
02/07/2012
Trade Name:
Sklice
Generic Name or Proper Name (*):
ivermectin
Indications Studied:
Topical treatment of head lice infestations
Label Changes Summary:
Safety and effectiveness in children 6 months and older have been established Safety has not been established in pediatric patients < 6 months. Sklice Lotion is not recommended in pediatric patients <6 months of age because of the potential increased systemic absorption and risk of ivermectin toxicityInformation on dosage and administration, adverse reactions, pharmacokinetics and clinical trialsNew drug
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Sanofi-Topaz, Inc.
Therapeutic Category:
Pediculocide, topical
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