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Title	Telbivudine Tablets 替比夫定片
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Excerpt	Indications: 1. Telbivudine is indicated for use in adult patients with chronic hepatitis B who have evidence of viral replication and persistently elevated serum transaminases (ALT or AST) or active liver histological lesions. 2. This indication is based on the virological, serological, biochemical, and histological responses of adult patients with chronic hepatitis B who are HBeAg-positive and HBeAg-negative and have compensated liver function and are naive to nucleoside analogs. The effect of telbivudine has not been evaluated in patients with hepatitis B who are co-infected with HIV, HCV, or HDV. The effect of telbivudine has not been evaluated in liver transplant recipients or patients with decompensated liver disease. There are no well-designed controlled studies of telbivudine in patients with chronic hepatitis B who are resistant to nucleoside analog reverse transcriptase inhibitors, but cross-resistance with lamivudine is anticipated. Dosage and Administration: 1. Adults and adolescents (≥16 years): The recommended dose for the treatment of chronic hepatitis B is 600 mg once daily, taken orally, before or after meals, regardless of food intake. The optimal course of treatment has not yet been determined. 2. Patients with Impaired Renal Function: This product can be used in patients with chronic hepatitis B and impaired renal function. No dosage adjustment is required for patients with a creatinine clearance of ≥50 ml/min. For patients with creatinine clearance 50ml/min and patients with end-stage renal disease (ESRD) receiving hemodialysis, the dosing interval needs to be adjusted: 1. Creatinine clearance ≥50ml/min: 600mg, once a day; 2. 30ml/min & creatinine clearance & 49ml/min: 600mg, once every 48 hours; 3. Creatinine clearance 30ml/min (no dialysis required): 600mg, once every 72 hours; 4. End-stage renal disease: 600mg, once every 96 hours; For patients with end-stage renal disease, this product should be taken after hemodialysis.
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