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Awiqli · 4.8 · Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Orga
Eintrag öffnenAwiqli · 4.8 · Based on results from clinical trials with insulin icodec, the frequency, type and severity of adverse reactio
Eintrag öffnenAwiqli · 4.8 · Description of selected adverse reactions
Eintrag öffnenAwiqli · 4.8 · For information on daily basal insulin comparators used in each trial, please see section 5.1.
Eintrag öffnenAwiqli · 4.8 · Hypersensitivity As with other insulins, allergic reactions may occur with insulin icodec. Immediate-type alle
Eintrag öffnenAwiqli · 4.8 · Hypersensitivity reactions (such as urticaria, lip swelling and swelling face) have been reported in the phase
Eintrag öffnenAwiqli · 4.8 · Hypoglycaemia Hypoglycaemia is the most commonly observed adverse drug reaction in patients using insulin icod
Eintrag öffnenAwiqli · 4.8 · Injection site reactions In the phase 3 trials, injection site reactions were reported in 1.6% of insulin icod
Eintrag öffnenAwiqli · 4.8 · ONWARDS 6 trial was followed by an extension part of 26 weeks treatment duration in order to investigate long-
Eintrag öffnenAwiqli · 4.8 · Other special populations
Eintrag öffnenAwiqli · 4.8 · Overall, in the phase 3 trials, the most common signs and symptoms of injection site reactions were erythema a
Eintrag öffnenAwiqli · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenAwiqli · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenAwiqli · 4.8 · See also section 5.1.
Eintrag öffnenAwiqli · 4.8 · Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous am
Eintrag öffnenAwiqli · 4.8 · Summary of the safety profile
Eintrag öffnenAwiqli · 4.8 · Table 2 Tabulated list of adverse reactions MedDRA Very common Common Uncommon Rare system organ classes Immun
Eintrag öffnenAwiqli · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenAwiqli · 4.8 · The main phase of ONWARDS 1 trial was followed by an extension part of 26 weeks treatment duration in order to
Eintrag öffnenAwiqli · 4.8 · The most frequently reported adverse reaction during clinical trials with insulin icodec is hypoglycaemia (see
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