Nebenwirkungen · Emtricitabine/Tenofovir disoproxil Mylan
Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 31
HOS-134303 · Präparat HOS-097542
Assessment of adverse reactions related to tenofovir disoproxil is based on two randomised trials (studies GS US 104 0321 and GS US 104 0352) in 184 HIV 1 infected paediatric patients (aged 2 to < 18 years) who received treatment with tenofovir disoproxil (n = 93) or placebo/active comparator (n = 91) in combination with other antiretroviral agents for 48 weeks (see section 5.1). The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2026-09-03T14:25:00Z · SHA-256 dca28001b5f37f5fac24ef504bb45938e413f238844fb60b012f3f9b5a32b40c · Passage 719b731271941c72b4e42f2eaea4429b02f329fef2b45e95d532f8faedfec174 · Zeichen 9569–10210 im Abschnitt