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Finlee · 4.5 · Interaction studies have only been performed in adults.
Eintrag öffnenFinlee · 4.5 · Interactions with many medicinal products eliminated through metabolism or active transport is expected. If th
Eintrag öffnenFinlee · 4.5 · Onset of induction is likely to occur after 3 days of repeat dosing with dabrafenib. Upon discontinuation of d
Eintrag öffnenFinlee · 4.5 · The number of affected medicinal products is expected to be large, although the magnitude of the interaction w
Eintrag öffnenFinlee · 4.6 Fertility, pregnancy, and lactation · 1
Eintrag öffnenFinlee · 4.8 Undesirable effects · 1
Eintrag öffnenFinlee · 4.8 · 14 Eye disorders Common Vision blurred, visual impairment, uveitis*4 Uncommon Retinal detachment, periorbital
Eintrag öffnenFinlee · 4.8 · 15 Description of selected adverse reactions
Eintrag öffnenFinlee · 4.8 · 16 Blood pressure should be measured at baseline and monitored during treatment, with control of hypertension
Eintrag öffnenFinlee · 4.8 · Adverse reactions (Table 4) are listed below by MedDRA system organ class ranked by frequency using the follow
Eintrag öffnenFinlee · 4.8 · Arthralgia Arthralgia was reported very commonly in the integrated adult and paediatric safety populations of
Eintrag öffnenFinlee · 4.8 · Blood pressure changes Hypertension was reported in 2.3% of paediatric patients, with Grade 3 events occurring
Eintrag öffnenFinlee · 4.8 · Cutaneous malignancies In the integrated adult safety population for dabrafenib in combination with trametinib
Eintrag öffnenFinlee · 4.8 · Haemorrhage Haemorrhagic events were observed in 34% of paediatric patients, with Grade 3 events occurring in
Eintrag öffnenFinlee · 4.8 · Hepatic events Hepatic adverse reactions have been reported in adult and paediatric clinical studies with dabr
Eintrag öffnenFinlee · 4.8 · Hypophosphataemia Hypophosphataemia has been reported commonly in the integrated adult and paediatric safety p
Eintrag öffnenFinlee · 4.8 · Hypotension was reported in 4.1% of paediatric patients, with Grade ≥3 events occurring in 2.3% of patients. T
Eintrag öffnenFinlee · 4.8 · In clinical studies of paediatric patients treated with dabrafenib in combination with trametinib, the most co
Eintrag öffnenFinlee · 4.8 · Infections and infestations Very common Paronychia, nasopharyngitis*1 Common Urinary tract infection, cellulit
Eintrag öffnenFinlee · 4.8 · Left ventricular ejection fraction (LVEF) reduction/Left ventricular dysfunction Decreased LVEF has been repor
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