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Osenvelt
Eintrag öffnenOsenvelt · 4.1 Therapeutic indications · 1
Eintrag öffnenOsenvelt · 4.3 Contraindications · 1
Eintrag öffnenOsenvelt · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Eintrag öffnenOsenvelt · 4.3 · Severe, untreated hypocalcaemia (see section 4.4).
Eintrag öffnenOsenvelt · 4.3 · Unhealed lesions from dental or oral surgery.
Eintrag öffnenOsenvelt · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenOsenvelt · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenOsenvelt · 4.5 · In clinical trials, denosumab has been administered in combination with standard anti-cancer treatment and in
Eintrag öffnenOsenvelt · 4.5 · No interaction studies have been performed.
Eintrag öffnenOsenvelt · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenOsenvelt · 4.8 Undesirable effects · 1
Eintrag öffnenOsenvelt · 4.8 · 7 Description of selected adverse reactions
Eintrag öffnenOsenvelt · 4.8 · 8 The trials in patients with breast or prostate cancer included a denosumab extension treatment phase (median
Eintrag öffnenOsenvelt · 4.8 · 9 1.0 - 51.7) and 33/3688 (0.9%) of patients treated with zoledronic acid (median exposure of 12.9 months; ran
Eintrag öffnenOsenvelt · 4.8 · A grade 3 decrease in serum calcium levels was experienced in 2.5% of patients treated with denosumab and 1.2%
Eintrag öffnenOsenvelt · 4.8 · A higher incidence of ONJ among patients treated with denosumab compared to zoledronic acid has been observed
Eintrag öffnenOsenvelt · 4.8 · A non-randomised, retrospective, observational study in 2,877 patients with cancer treated with denosumab or z
Eintrag öffnenOsenvelt · 4.8 · Accompanying increases in parathyroid hormone have also been observed in patients receiving denosumab with sev
Eintrag öffnenOsenvelt · 4.8 · Atypical fractures of the femur In the clinical trial programme overall, atypical femoral fractures have been
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