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Spexotras · 4.8 · 14 The risk of haemorrhage may be increased with concomitant use of antiplatelet or anticoagulant therapy. If
Eintrag öffnenSpexotras · 4.8 · 15 acuity and other visual disturbances have been reported in adult clinical studies with trametinib (see sect
Eintrag öffnenSpexotras · 4.8 · Adverse reactions (Table 5) are listed below by MedDRA system organ class ranked by frequency using the follow
Eintrag öffnenSpexotras · 4.8 · Blood pressure changes Hypertension was reported in 2.3% of paediatric patients, with Grade 3 events occurring
Eintrag öffnenSpexotras · 4.8 · Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension by
Eintrag öffnenSpexotras · 4.8 · Description of selected adverse reactions
Eintrag öffnenSpexotras · 4.8 · Haemorrhage Haemorrhagic events were observed in 34% of paediatric patients, with Grade 3 events occurring in
Eintrag öffnenSpexotras · 4.8 · Hepatic events Hepatic adverse reactions have been reported in adult and paediatric clinical studies with tram
Eintrag öffnenSpexotras · 4.8 · Hypotension was reported in 4.1% of paediatric patients, with Grade ≥3 events occurring in 2.3% of patients. T
Eintrag öffnenSpexotras · 4.8 · In clinical studies of paediatric patients treated with trametinib in combination with dabrafenib, the most co
Eintrag öffnenSpexotras · 4.8 · Infections and infestations Very common Paronychia, nasopharyngitis*1 Common Urinary tract infection, cellulit
Eintrag öffnenSpexotras · 4.8 · Interstitial lung disease (ILD)/Pneumonitis Patients treated with trametinib may develop ILD or pneumonitis. T
Eintrag öffnenSpexotras · 4.8 · Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction Decreased LVEF has been repor
Eintrag öffnenSpexotras · 4.8 · Pancreatitis Pancreatitis was reported in 1.2% of paediatric patients, with <1% of patients with Grade 3 sever
Eintrag öffnenSpexotras · 4.8 · Patients with LVEF lower than the institutional lower limit of normal were not included in clinical studies wi
Eintrag öffnenSpexotras · 4.8 · Pyrexia Pyrexia has been reported in clinical studies with trametinib as monotherapy and in combination with d
Eintrag öffnenSpexotras · 4.8 · Rash Rash has been observed in 49% of paediatric patients in trametinib and dabrafenib combination studies in
Eintrag öffnenSpexotras · 4.8 · Renal failure Renal failure has been reported with trametinib in combination with dabrafenib. Renal failure du
Eintrag öffnenSpexotras · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenSpexotras · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
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