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Begriffe & Kennungen
Cotellic · 4.8 · No dose adjustment is recommended in patients with hepatic impairment (see section 5.2).
Eintrag öffnenCotellic · 4.8 · No evidence of phototoxicity was observed with Cotellic as a single agent.
Eintrag öffnenCotellic · 4.8 · No pharmacokinetic trial in subjects with renal impairment has been conducted. Dose adjustment is not recommen
Eintrag öffnenCotellic · 4.8 · Paediatric population
Eintrag öffnenCotellic · 4.8 · Photosensitivity
Eintrag öffnenCotellic · 4.8 · Photosensitivity has been observed with a higher frequency in the Cotellic plus vemurafenib arm vs placebo plu
Eintrag öffnenCotellic · 4.8 · Please refer to the vemurafenib SmPC for complete descriptions of all undesirable effects associated with vemu
Eintrag öffnenCotellic · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenCotellic · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenCotellic · 4.8 · Respiratory, thoracic and Pneumonitis mediastinal disorders Gastrointestinal Diarrhoea, Nausea, disorders Vomi
Eintrag öffnenCotellic · 4.8 · Rhabdomyolysis
Eintrag öffnenCotellic · 4.8 · Rhabdomyolysis has been reported in the post-marketing setting. Signs or symptoms of rhabdomyolysis warrant an
Eintrag öffnenCotellic · 4.8 · Serous retinopathy
Eintrag öffnenCotellic · 4.8 · Skin and subcutaneous Photosensitivityb, Rash, tissue disorders Rash maculo-papular, Dermatitis acneiform, Hyp
Eintrag öffnenCotellic · 4.8 · Special populations
Eintrag öffnenCotellic · 4.8 · Summary of the safety profile
Eintrag öffnenCotellic · 4.8 · System organ class Very Common Common Uncommon
Eintrag öffnenCotellic · 4.8 · Table 3 lists adverse reactions considered associated with the use of Cotellic. Within each frequency grouping
Eintrag öffnenCotellic · 4.8 · Table 4 Liver function and other laboratory tests observed in the Phase III Study GO28141
Eintrag öffnenCotellic · 4.8 · Table 4 provides the frequency of measured liver laboratory abnormalities and elevated creatine phosphokinase
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