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Eintrag öffnenHalaven · 4.1 Therapeutic indications · 1
Eintrag öffnenHalaven · 4.3 Contraindications · 1
Eintrag öffnenHalaven · 4.3 · - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding
Eintrag öffnenHalaven · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenHalaven · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenHalaven · 4.5 · At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B
Eintrag öffnenHalaven · 4.5 · Effects of eribulin on the pharmacokinetics of other medicines
Eintrag öffnenHalaven · 4.5 · Eribulin does not inhibit the CYP enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 or 2E1 at relevant clinical concent
Eintrag öffnenHalaven · 4.5 · Eribulin is mainly (up to 70%) eliminated through biliary excretion. The transport protein involved in this pr
Eintrag öffnenHalaven · 4.5 · In vitro data indicate that eribulin is a mild inhibitor of the important drug metabolising enzyme CYP3A4. No
Eintrag öffnenHalaven · 4.5 · No drug-drug interactions are expected with CYP3A4 inhibitors and inducers. Eribulin exposure (AUC and Cmax) w
Eintrag öffnenHalaven · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenHalaven · 4.8 Undesirable effects · 1
Eintrag öffnenHalaven · 4.8 · 6 System Organ Adverse Reactions – all Grades Class Very Common Common Uncommon Rare or not (Frequency %) (Fre
Eintrag öffnenHalaven · 4.8 · 7 System Organ Adverse Reactions – all Grades Class Very Common Common Uncommon Rare or not (Frequency %) (Fre
Eintrag öffnenHalaven · 4.8 · 8 307/404 (76.0%) and 1314/1559 (84.3%), respectively. The median duration of treatment was 12.0 weeks for sar
Eintrag öffnenHalaven · 4.8 · 9 1.23 mg/m2 on Days 1 and 8 and irinotecan 20 or 40 mg/m2 on Days 1 to 5 of a 21-day cycle, or 100 or 125 mg/
Eintrag öffnenHalaven · 4.8 · Description of selected adverse reactions
Eintrag öffnenHalaven · 4.8 · Disseminated intravascular coagulation Cases of disseminated intravascular coagulation have been reported, typ
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