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Skin and appendagesAllergic reactions including anaphylaxisangioedemabullous eruptionsulcerative stomatitis and urticaria have all been reportedhypersensitivity syndrome and hypersensitivity reactions with rash associated with constitutional findingsegfeverblisteringoral lesionsconjunctivitisfacial edemamuscle or joint achesgeneral malaisefatigueor significant hepatic abnormalitiesdrug reaction with eosinophilia and systemic symptomsDRESS

Discontinue immediately with signs or symptoms of hepatitis or increased transaminase levels combined with rash or other systemic symptoms.

Indicated for treatment of HIV-1 infection in combination with other antiretroviralsalso used for prevention of maternal-fetal HIV transmission in women with no prior antiretroviral treatment.

While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmissiona residual risk cannot be excludedPrecautions to prevent transmission should be taken in accordance with national guidelines.

The safety and efficacy of Viramune has not been established in patients with significant underlying liver disordersViramune is contraindicated in patients with severe hepatic impairmentChild-Pugh Csee section 4.3Pharmacokinetic results suggest caution should be exercised when nevirapine is administered to patients with moderate hepatic dysfunctionChild-Pugh BPatients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactionsIn the case of concomitant antiviral therapy for hepatitis B or Cplease refer also to the relevant product information for these medicinal products.

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