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Eintrag öffnenTasigna · 4.1 Therapeutic indications · 1
Eintrag öffnenTasigna · 4.3 Contraindications · 1
Eintrag öffnenTasigna · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenTasigna · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenTasigna · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenTasigna · 4.5 · 10 The exposure to nilotinib in healthy subjects was increased 3-fold when co-administered with the strong CYP
Eintrag öffnenTasigna · 4.5 · 11 Anti-arrhythmic medicinal products and other substances that may prolong the QT interval
Eintrag öffnenTasigna · 4.5 · A single-dose drug-drug interaction study in healthy volunteers with 25 mg warfarin, a sensitive CYP2C9 substr
Eintrag öffnenTasigna · 4.5 · Concomitant administration of nilotinib with imatinib (a substrate and moderator of P-gp and CYP3A4), had a sl
Eintrag öffnenTasigna · 4.5 · Food interactions
Eintrag öffnenTasigna · 4.5 · In CML patients, nilotinib administered at 400 mg twice daily for 12 days increased the systemic exposure (AUC
Eintrag öffnenTasigna · 4.5 · In a study in healthy subjects, no significant change in nilotinib pharmacokinetics was observed when a single
Eintrag öffnenTasigna · 4.5 · In the same study as above, administration of an antacid (aluminium hydroxide/magnesium hydroxide/simethicone)
Eintrag öffnenTasigna · 4.5 · In vitro, nilotinib is a relatively strong inhibitor of CYP3A4, CYP2C8, CYP2C9, CYP2D6 and UGT1A1, with Ki val
Eintrag öffnenTasigna · 4.5 · Interaction studies have only been performed in adults.
Eintrag öffnenTasigna · 4.5 · Nilotinib has pH dependent solubility, with lower solubility at higher pH. In healthy subjects receiving esome
Eintrag öffnenTasigna · 4.5 · Nilotinib is mainly metabolised in the liver with CYP3A4 expected to be the main contributor to the oxidative
Eintrag öffnenTasigna · 4.5 · Nilotinib should be used with caution in patients who have or may develop prolongation of the QT interval, inc
Eintrag öffnenTasigna · 4.5 · Paediatric population
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