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The CHMP decided that Sustiva’s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents and children three months of age and older. The Committee noted that Sustiva has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working. The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Sustiva in the past but which sped working, although there is no evidence to suggest that protease inhibitors may not work in these patients. The Committee recommended that Sustiva be given marketing authorisation.The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. LANTUS has a pH of approximately 4.A 42-year-old HIV-positive woman's saquinavir in her highly active antiretroviral therapy was replaced with this drug to increase compliance. Two weeks after initiation, the patient reported severe and constant burning in her tongue, gums, and oral mucosa and was diagnosed with burning mouth syndrome (BMS). Efavirenz (the active ingredient contained in Sustiva) was discontinued and the BMS resolved within a week.[Ref]

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Cyclo-oxygenase is an enzyme that is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced in response to injury or certain diseases and cause pain, swelling and inflammation.

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