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Eintrag öffnenTegsedi · 4.1 Therapeutic indications · 1
Eintrag öffnenTegsedi · 4.3 Contraindications · 1
Eintrag öffnenTegsedi · 4.3 · Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Platelet count < 1
Eintrag öffnenTegsedi · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenTegsedi · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenTegsedi · 4.5 · Caution should be exercised with concomitant use of nephrotoxic medicinal products and other medicines that ma
Eintrag öffnenTegsedi · 4.5 · Caution should be used with antithrombotic medicinal products, antiplatelet medicinal products, and medicinal
Eintrag öffnenTegsedi · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenTegsedi · 4.8 Undesirable effects · 1
Eintrag öffnenTegsedi · 4.8 · 7 System Organ Common Uncommon Not known Very Common Class Blood and Thrombocytopenia Eosinophilia lymphatic s
Eintrag öffnenTegsedi · 4.8 · 8 intracranial haemorrhage. Patients should be monitored for thrombocytopenia during treatment with inotersen
Eintrag öffnenTegsedi · 4.8 · Description of selected adverse reactions
Eintrag öffnenTegsedi · 4.8 · Immunogenicity In the pivotal Phase 2/3 study, 30.4% of patients treated with inotersen tested positive for an
Eintrag öffnenTegsedi · 4.8 · Injection site reactions The most frequently observed events included those associated with injection site rea
Eintrag öffnenTegsedi · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenTegsedi · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenTegsedi · 4.8 · Skin and Pruritus subcutaneous Rash disorders Renal and urinary Glomerulonephritis disorders Proteinuria Renal
Eintrag öffnenTegsedi · 4.8 · Summary of the safety profile
Eintrag öffnenTegsedi · 4.8 · Table 2 presents the adverse drug reactions (ADRs) listed by MedDRA system organ class. Within each system org
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