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Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
Date:11/12/2007

che, and nausea. Children taking KALETRA may sometimes get a skin rash. Other side effects may occur.

Pancreatitis and liver problems, which can be fatal, have been reported in patients receiving KALETRA. Patients should tell their doctor if they have nausea, vomiting, or abdominal pain, which may be signs of pancreatitis, or if they have or have had liver disease such as Hepatitis B or C.

Some patients have had large increases in triglycerides and cholesterol. Changes in body fat have been seen in some patients taking anti-HIV therapy. The long-term health effects of these conditions are not known at this time. Diabetes and high blood sugar have occurred in patients taking protease inhibitors such as KALETRA.

Some patients with hemophilia have increased bleeding with protease inhibitors.

The effects of KALETRA on pregnant women or their unborn babies are not known. Mothers taking KALETRA should not breast-feed.

All strengths of KALETRA tablets should be swallowed whole and not chewed, broken, or crushed.

KALETRA tablets should be stored at room temperature. Exposure of this product to high humidity outside the pharmacy container for longer than 2 weeks is not recommended.

Refrigerated KALETRA oral solution remains stable until the expiration date printed on the label. If stored at room temperature up to 77F (25C), KALETRA oral solution should be used within 2 months.

Avoid exposure to excessive heat. For full prescribing information visit http://www.kaletra.com.

Abbott and HIV

Abbott has been a leader in HIV/AIDS research since the early years of the epidemic. In 1985, the company developed the first licensed test to detect HIV antibodies in the blood and remains a leader in HIV diagnostics. Abbott retroviral and hepatitis tests are used to screen more than half of the world's donated blood supply. Abbott has developed two protease inhibitors for the treat
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