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Schering-Plough wishes to announce the launch of Rebetol (ribavirin) 40mg/ml Oral Solution. Rebetol Oral Solution is a clear, colourless to pale or light yellow oral solution intended for use in a combination regimen with interferon alfa-2b for the treatment of chronic hepatitis C in children and adolescents 3 years of age and older.
Patients should not have been previously treated, show no liver decompensation, and should be positive for serum HCV-RNA. When deciding to treat a pediatric patient, evidence of disease progression, such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load, should be considered. The benefit of treatment should be weighed against the safety findings observed for paediatric subjects in the clinical trials. Rebetol is also available in capsules as part of a combination regimen with interferon alfa-2b (in previously untreated adults, children ≥3-years, and adolescents), but also as part of a combination regimen with peginterferon alfa-2b (in adults previously untreated or who have failed previous alpha interferon therapy). There safety and efficacy of Rebetol with pegylated or other forms of interferon (i.e., not alfa-2b) in children or adolescents have not been established. Full prescribing information and references available from Schering-Plough Ltd. Telephone: +44 (1707) 363636. Fax: +44 (1707) 363763. E-mail: medical.info@spcorp.com