The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended that new warnings be included in the product information for Sebivo (telbivudine), from Novartis Europharm Ltd. This warning is intended to inform doctors about the risk of peripheral neuropathy in patients with chronic hepatitis B who are being treated with Sebivo.
Doctors are advised to monitor patients carefully for signs of peripheral neuropathy and to reconsider treatment options if they suspect that a patient is developing peripheral neuropathy. Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis as monotherapy only.
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Doctors are advised to monitor patients carefully for signs of peripheral neuropathy and to reconsider treatment options if they suspect that a patient is developing peripheral neuropathy. Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis as monotherapy only.
Discuss Add this link to... Bury
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