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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  11/09/2007
Trade Name:  Kaletra Oral Solution, 80 mg/20 mg & Kaletra (1opinavir/ritonavir) Tablets, 200 mg/50 mg
Generic Name or Proper Name (*):  lopinavir/ ritonavir
Indications Studied:  HIV -1 protease inibitor indicated in combination with other antiretroviral agents for the treatment of HIV -1 infection.
Label Changes Summary:  * Dosing and administration information provided for children * Use of a lower strength tablet in a twice daily dosing regimen for pediatric patients weighing greater than 15 kg * New dosing regimen
Product Labeling:  Labeling  Opens a new window
Sponsor:  Abbott Laboratories
Therapeutic Category:  Antiviral