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Ontruzant · 4.8 · 13 System organ class Adverse reaction Frequency Infusion related reaction Very common Pain Very common Pyrexi
Eintrag öffnenOntruzant · 4.8 · 14 to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infus
Eintrag öffnenOntruzant · 4.8 · All the terms included are based on the highest percentage seen in pivotal clinical trials. In addition, terms
Eintrag öffnenOntruzant · 4.8 · Amongst the most serious and/or common adverse reactions reported in Ontruzant usage to date are cardiac dysfu
Eintrag öffnenOntruzant · 4.8 · Anaphylactoid reactions have been observed in isolated cases.
Eintrag öffnenOntruzant · 4.8 · Cardiac dysfunction
Eintrag öffnenOntruzant · 4.8 · Congestive heart failure (NYHA Class II-IV) is a common adverse reaction associated with the use of trastuzuma
Eintrag öffnenOntruzant · 4.8 · Description of selected adverse reactions
Eintrag öffnenOntruzant · 4.8 · Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (s
Eintrag öffnenOntruzant · 4.8 · Haematotoxicity Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commo
Eintrag öffnenOntruzant · 4.8 · Immunogenicity
Eintrag öffnenOntruzant · 4.8 · In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of
Eintrag öffnenOntruzant · 4.8 · In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of
Eintrag öffnenOntruzant · 4.8 · In the pivotal metastatic trials of intravenous trastuzumab, the incidence of cardiac dysfunction varied betwe
Eintrag öffnenOntruzant · 4.8 · In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to
Eintrag öffnenOntruzant · 4.8 · Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40% of pat
Eintrag öffnenOntruzant · 4.8 · Presented in Table 1 are adverse reactions that have been reported in association with the use of intravenous
Eintrag öffnenOntruzant · 4.8 · Pulmonary events Severe pulmonary adverse reactions occur in association with the use of trastuzumab and have
Eintrag öffnenOntruzant · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenOntruzant · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
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