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Monitoring during the first 18 wk of therapy essentialextra vigilance warranted during first 6 wk of therapyperiod of greatest risk)

In reproductive toxicology studiesevidence of impaired fertility was seen in rats.

In some caseshepatic injury has progressed despite discontinuation of treatmentPatients developing signs or symptoms of hepatitissevere skin reaction or hypersensitivity reactions must discontinue nevirapine and seek medical evaluation immediatelyNevirapine must not be restarted following severe hepaticskin or hypersensitivity reactionssee section 4.3

The Committee noted that most of the experience with Viramune was in combination with nucleoside reverse-transcriptase inhibitorsNRTIsa type of antiviral medicineand that there was insufficient evidence on the use of combination treatment including a protease inhibitoranother type of antiviral medicineafter Viramune treatmentThe Committee recommended that Viramune be given marketing authorisation.

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in this open-label trial, 443 subjects already on an antiviral regimen containing immediate-release viramune 200 mg twice daily with hiv-1 rna less than 50 copies ml were randomized in a 2 1 ratio to viramune xr 400 mg once daily or immediate-release viramune 200 mg twice daily.

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