Miércoles, 10 de febrero 2010
 

Comunicados

COMUNICADO: Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender

    Abbott and the company's philanthropic foundation, Abbott Fund, have invested more than US$100 million in the fight against HIV/AIDS in Africa and the developing world. Abbott Fund-supported programs have served more than 700,000 children and families. In addition, more than 250,000 patients have been tested through Abbott Fund-supported voluntary counseling and testing programs, with thousands being referred to treatment programs. Abbott also has donated more than eight million rapid HIV tests to help prevent mother-to-child HIV transmission.

    Abbott and Abbott Fund have announced several efforts to expand access to treatment and care for children living with HIV/AIDS, including an additional investment of US$12 million in grants and product donations this year.

    For more information about Abbott's commitment to fighting HIV/AIDS, please visit http://www.abbott.com/hiv.  

    About Kaletra

    Indication

    KALETRA (lopinavir/ritonavir) is a human immunodeficiency virus-1 (HIV-1) protease inhibitor. KALETRA is always used in combination with other anti-HIV-1 medicines for the treatment of HIV-1 infection. KALETRA is a combination of two medicines, lopinavir and ritonavir. KALETRA is for adults and for children age six months and older.  

    Important Safety Information

    KALETRA does not cure HIV-1 infection or AIDS and does not reduce the risk of passing HIV-1 to others.

    KALETRA must not be taken by patients who have had an allergic reaction to KALETRA or any of its ingredients.

    Taking KALETRA with certain drugs can cause serious problems or death. KALETRA must not be taken with dihydroergotamine, ergonovine, ergotamine or methylergonovines such as Cafergot(R), Migranal(R), D.H.E. 45(R), ergotrate maleate, and methergine, as well as Halcion(R) (triazolam), Orap(R) (pimozide), Propulsid(R) (cisapride), or Versed(R) (midazolam).

    KALETRA must not be taken with rifampin, also known as Rimactane(R), Rifadin(R), Rifater(R), or Rifamate(R); St. John's Wort (hypericum perforatum); Mevacor(R) (lovastatin), or Zocor(R) (simvastatin).

    There are drug-drug interactions with the potential for risk of serious or life-threatening side effects. Alterations in dose, increased monitoring of drug levels in the blood, or increased observations for side effects may be recommended when KALETRA is taken with: Lipitor(R) (atorvastatin), Crestor(R) (rosuvastatin), Viagra(R) (sildenafil), Cialis(R) (tadalafil), Levitra(R) (vardenafil), oral contraceptives ("the pill") or the contraceptive patch, Mycobutin(R) (rifabutin), inhaled Flonase(R) (fluticasone), metronidazole, or disulfiram. Patients should talk with their doctor about all medicines they are taking or planning to take, including those without a prescription and herbal products.

    KALETRA should not be given once-daily in combination with Sustiva(R) (efavirenz), Viramune(R) (nevirapine), Agenerase(R) (amprenavir), fosamprenavir, Viracept(R) (nelfinavir), phenobarbital, Dilantin(R) (phenytoin) or Tegretol(R) carbamazepine.

    Patients and/or their care providers should pay special attention to accurate administration of the KALETRA dose to reduce the risk of accidentally giving too much or too little medicine.

    The most commonly reported side effects of moderate severity that are thought to be drug related are abdominal pain, abnormal bowel movements, diarrhea, feeling weak/tired, headache 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 two 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 77 degrees F (25 degrees C), KALETRA oral solution should be used within two months.

    Avoid exposure to excessive heat.  

    Abbott and HIV/AIDS

    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 treatment of HIV.  

    About Abbott Fund

    Abbott Fund is a philanthropic foundation established by Abbott in 1951. Abbott Fund's mission is to create healthier global communities by investing in creative ideas that promote science, expand health care and strengthen communities worldwide.  

    About Abbott

    Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.

    Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com. For more information on Abbott's HIV/AIDS programs, please visit http://www.abbott.com/hiv and http://www.abbottglobalcare.org.  

    Web site: http://www.abbott.com  

International, Dirk van Eeden, +1-847-938-8848, or Susan Beverly, +1-847-935-9096, or U.S. Media, Julie Herlocker, +1-847-936-6116, all of Abbott





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