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Savene
Eintrag öffnenSavene · 4.1 Therapeutic indications · 1
Eintrag öffnenSavene · 4.3 Contraindications · 1
Eintrag öffnenSavene · 4.3 · • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Women of child
Eintrag öffnenSavene · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenSavene · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenSavene · 4.5 · Co-administration of doxorubicin (50 to 60 mg/m2) or epirubicin (60 to 100 mg/m2) did not affect dexrazoxane p
Eintrag öffnenSavene · 4.5 · Concomitant use contraindicated: Yellow fever vaccine: Risk of fatal generalised vaccinial disease (see sectio
Eintrag öffnenSavene · 4.5 · Concomitant use not recommended: • Other live attenuated vaccines: risk of systemic, possible fatal disease. T
Eintrag öffnenSavene · 4.5 · Concomitant use to assess carefully: Ciclosporin, tacrolimus: Excessive immunosuppression with risk of lymphop
Eintrag öffnenSavene · 4.5 · Interaction specific to dexrazoxane: When tested in five major cytochrome P450 isoenzymes CYP1A, CYP2C9, CYP2C
Eintrag öffnenSavene · 4.5 · Interactions common to all cytotoxics: • Due to an increased thrombotic risk in patients with malignant diseas
Eintrag öffnenSavene · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenSavene · 4.8 Undesirable effects · 1
Eintrag öffnenSavene · 4.8 · 5 System Organ Classes (SOC) Frequency Adverse reactions Infections and infestations Very common Postoperative
Eintrag öffnenSavene · 4.8 · 6 Incidence of laboratory abnormalities in TT01 and TT02 (n=80 patients) No of patients with CTC grade 3-4 Lab
Eintrag öffnenSavene · 4.8 · A number of published reports comprising more than 1000 patients have demonstrated a uniform pattern of dose d
Eintrag öffnenSavene · 4.8 · Incidence of adverse reactions (MedDRA) in studies TT01 and TT02 (n=80 patients) (Note that numbers for Blood
Eintrag öffnenSavene · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenSavene · 4.8 · The adverse reactions were those typically seen with standard chemotherapy and also with dexrazoxane: Nausea/v
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