Tenofovir Disoproxil Fumarate Tablets Reference Listed Drug

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Name	Tenofovir Disoproxil Fumarate Tablets
Trade name	Viread
Specifications	300mg
MAHolder	AspenPortElizabeth(Pty)Ltd
Original	U.K.

Tenofovir Disoproxil Fumarate Tablets are indicated for the following:
1. HIV-1 infection
Tenofovir disoproxil fumarate is suitable for combination with other antiretroviral drugs to treat adult HIV-1 infection. When starting the treatment of HIV-1 infection with tenofovir disoproxil fumarate, the following points should be considered: Tenofovir disoproxil fumarate should not be combined with fixed-dose compound preparations containing tenofovir, including: Efavirenz/ Emtricitabine/ Tenofovir Disoproxil fumarate, Ripavirin/ Emtricitabine/ Tenofovir Disoproxil fumarate, Averevir/ Kebilast/ Emtricitabine/ Tenofovir disoproxil fumarate, Emtricitabine tenofovir.
2. Chronic hepatitis B
Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B adults and children ≥ 12 years old. When starting tenofovir disoproxil fumarate to treat HBV infection, the following points should be considered: The establishment of this indication in adult patients is based on safety and efficacy data obtained from subjects who have received nucleoside therapy for the first time and subjects who have previously received treatment and confirmed lamivudine resistance. The subjects were HBeAg-positive and HBeAg-negative adult subjects with chronic hepatitis B with compensatory liver function. Tenofovir disoproxil fumarate has been evaluated in a limited number of chronic hepatitis B subjects with decompensated liver disease. In clinical trials, the number of subjects with adefovir-related mutations at baseline is too small, so no conclusion can be drawn on the efficacy.

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