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Medical Advocates Lopinavir/Ritonavir (Kaletra/Aluvia)

Product Information Abbott Laboratories Information Kaletra Adult PI US FDA Updates Kaletra Patient Information

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Last Update:  December 06, 2014
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US FDA Updates

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NEWS RELEASE FDA approved a new half-strength Kaletra tablet formulation. Each film-coated tablet contains 100 mg lopinavir and 25 mg ritonavir. The major changes to the label include clear instructions regarding the importance of accurate calculation of the dose of Kaletra to minimize the risk for medication errors and overdose or under dose, and the addition of tablet dosing to section 2.2 Pediatric Patients as described in the pdf attachment. US FDA November 16, 2007 NEWS RELEASE Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra (lopinavir/ritonavir) Tablet for Pediatric HIV Patients Abbott Laboratories  November 12, 2007 FULL-TEXT DOCUMENT Kaletra (lopinavir/ritonavir) Product Label Update USFDA  May 23, 2007 News Release FULL-TEXT DOCUMENT FDA Approval for New Kaletra (lopinavir/ritonavir) Tablet Formulation for HIV Patients Abbott Laboratories October 31, 2005 FULL-TEXT DOCUMENT FDA Approves KALETRA 800/200mg once-daily administration for the treatment of HIV-infection in therapy-naïve adult patients, USFDA  April 29, 2005 News Release FULL-TEXT DOCUMENT Norvir (ritonavir) and Kaletra (lopinavir/ritonavir) package inserts updated to include information regarding interactions with fluticasone FDA  March 30, 2005 News Release

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Lopinavir/Ritonavir Product Information