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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:
12/16/2016
Trade Name:
Ryzodeg 70/30
Generic Name or Proper Name (*):
insulin degludec/insulin aspart
Indications Studied:
Improve glycemic control in type 1 and type 2 diabetes mellitus in pediatric patients 1 year and older
Label Changes Summary:
*Expanded indication from adults to pediatric patients 1 year and older. *Use in pediatric patients 1 year and older with type 1 and type 2 diabetes mellitus is supported by evidence from an adequate and well-controlled study and a pharmacokinetic study. Use in pediatric patients 1 year and older with type 2 diabetes mellitus is also supported by evidence from adequate and well-controlled studies in adults with type 2 diabetes mellitus. *Safety and effectiveness have not been established in pediatric patients less than 1 year old. *In pediatric patients 1 year and older with switching from other insulin therapies, start Ryzodeg 70/30 at a reduced dose to minimize the risk of hypoglycemia. *In pediatric patients inject Ryzodeg 70/30 subcutaneously once daily with any main meal. *Not recommended for pediatric patients requiring less than 5 units of Ryzodeg 70/30 daily. *Adverse reactions similar to those observed in adults. *Information on dosing, PK, and clinical trials. *Postmarketing study.
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Novo Nordisk
NNPS:
FALSE
Therapeutic Category:
Antidiabetic
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