“…A limit test may be performed if no effects would be expected at a dose of 1000 mg/kg bw/d. The results of this study include measurements (weighing) and clinical daily observations, each day preferably at the same time. …”

“…Emtricitabine/tenofovir alafenamide fumarate (FTC/TAF) (200 mg/10 mg and 200 mg/25 mg) is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors (NRTIs) indicated for use in combination with other antiretroviral therapies (ARTs) for the treatment of HIV type 1 infection in adults and pediatric patients 12 years of age and older (and weighing ≥ 35 kg). It is available as 200 mg/10 mg and 200 mg/25 mg film-coated tablets; the recommended dose is one 200 mg/10 mg tablet daily when used in combination with a ritonavir- or cobicistat (COBI)-boosted protease inhibitor. …”