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Steglatro · 4.8 · 9 Description of selected adverse reactions
Eintrag öffnenSteglatro · 4.8 · Across 7 other phase 3 clinical trials in the ertugliflozin development program, the incidences of urinary tra
Eintrag öffnenSteglatro · 4.8 · Adverse reactions listed below are classified according to frequency and system organ class (SOC), within each
Eintrag öffnenSteglatro · 4.8 · Blood creatinine increased/Glomerular filtration rate decreased and renal-related events Initial increases in
Eintrag öffnenSteglatro · 4.8 · Common Balanitis candida and other male genital mycotic infections*,†
Eintrag öffnenSteglatro · 4.8 · Diabetic ketoacidosis In VERTIS CV, ketoacidosis was identified in 19 (0.3%) ertugliflozin-treated patients an
Eintrag öffnenSteglatro · 4.8 · Genital mycotic infections In the pool of three placebo-controlled clinical trials, female genital mycotic inf
Eintrag öffnenSteglatro · 4.8 · Hypoglycaemia In the pool of placebo-controlled studies, the incidence of documented hypoglycaemia was increas
Eintrag öffnenSteglatro · 4.8 · In VERTIS CV, treatment with ertugliflozin was associated with an initial decrease in mean eGFR (at Week 6, -2
Eintrag öffnenSteglatro · 4.8 · In patients with moderate renal impairment taking insulins, sulphonylurea, or meglitinides as background medic
Eintrag öffnenSteglatro · 4.8 · In the VERTIS CV sub-studies, when ertugliflozin was added to insulin with or without metformin, the incidence
Eintrag öffnenSteglatro · 4.8 · In the same pool, male genital mycotic infections (e.g., balanitis candida, balanoposthitis, genital infection
Eintrag öffnenSteglatro · 4.8 · Not known Necrotising fasciitis of the perineum (Fournier’s gangrene)*,a Metabolism and nutrition disorders Co
Eintrag öffnenSteglatro · 4.8 · Pool of placebo-controlled trials evaluating Steglatro 5 mg and 15 mg The primary assessment of safety was con
Eintrag öffnenSteglatro · 4.8 · Rare DKA*,† Vascular disorders Common Volume depletion*,† Skin and subcutaneous tissue disorders Not known Ras
Eintrag öffnenSteglatro · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenSteglatro · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenSteglatro · 4.8 · Summary of the safety profile
Eintrag öffnenSteglatro · 4.8 · System organ class Adverse reaction Frequency Infections and infestations Very common Urinary tract infections
Eintrag öffnenSteglatro · 4.8 · Tabulated list of adverse reactions
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