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Lonquex · 4.8 · Overall, the safety profile in paediatric patients appeared similar to that observed in adult clinical studies
Eintrag öffnenLonquex · 4.8 · Paediatric population
Eintrag öffnenLonquex · 4.8 · Pulmonary adverse reactions, in particular interstitial pneumonia, have been reported (see section 4.4). These
Eintrag öffnenLonquex · 4.8 · Renal and urinary disorders - Glomerulonephritis (see section 4.4)
Eintrag öffnenLonquex · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenLonquex · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenLonquex · 4.8 · Reversible, mild to moderate elevations in alkaline phosphatase and lactate dehydrogenase may occur, with no a
Eintrag öffnenLonquex · 4.8 · Skin and subcutaneous tissue disorders - Acute febrile neutrophilic dermatosis (Sweet’s syndrome) - Cutaneous
Eintrag öffnenLonquex · 4.8 · Skin reactions such as erythema and rash may occur.
Eintrag öffnenLonquex · 4.8 · Splenomegaly, generally asymptomatic, has been reported (see section 4.4).
Eintrag öffnenLonquex · 4.8 · Summary of the safety profile
Eintrag öffnenLonquex · 4.8 · Table 2: Adverse reactions System organ class Frequency Adverse reaction Blood and lymphatic system Common Thr
Eintrag öffnenLonquex · 4.8 · The adverse reactions listed below in table 2 are classified according to system organ class. Frequency groupi
Eintrag öffnenLonquex · 4.8 · The most frequent adverse reactions include musculoskeletal pains such as bone pain and myalgia. Musculoskelet
Eintrag öffnenLonquex · 4.8 · The most frequent undesirable effects are musculoskeletal pain and nausea.
Eintrag öffnenLonquex · 4.8 · The safety assessment in paediatric patients is limited to the clinical study data from the following studies:
Eintrag öffnenLonquex · 4.8 · The safety of lipegfilgrastim has been evaluated based on results from clinical studies including 506 patients
Eintrag öffnenLonquex · 4.8 · Thrombocytopenia and leukocytosis have been reported (see section 4.4).
Eintrag öffnenLonquex · 4.8 · Vascular disorders - Capillary leak syndrome Cases of capillary leak syndrome have been reported in post marke
Eintrag öffnenLonquex · 4.8 · Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
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