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Xultophy · 4.5 · Warfarin and other coumarin derivatives No interaction study has been performed. A clinically relevant interac
Eintrag öffnenXultophy · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenXultophy · 4.8 Undesirable effects · 1
Eintrag öffnenXultophy · 4.8 · 8 MedDRA System organ class Frequency Adverse reaction Not known Cutaneous amyloidosis† General disorders and
Eintrag öffnenXultophy · 4.8 · 9 listed in Appendix V.
Eintrag öffnenXultophy · 4.8 · Adverse reactions associated with Xultophy are given below, listed by system organ class and frequency. Freque
Eintrag öffnenXultophy · 4.8 · Allergic reactions Allergic reactions (manifested with signs and symptoms such as urticaria (0.3% of patients
Eintrag öffnenXultophy · 4.8 · Description of selected adverse reactions
Eintrag öffnenXultophy · 4.8 · Gastrointestinal adverse reactions Gastrointestinal adverse reactions may occur more frequently at the beginni
Eintrag öffnenXultophy · 4.8 · Hypoglycaemia Hypoglycaemia may occur if the Xultophy dose is higher than required. Severe hypoglycaemia may l
Eintrag öffnenXultophy · 4.8 · Increased heart rate Mean increase in heart rate from baseline of 2 to 3 beats per minute has been observed in
Eintrag öffnenXultophy · 4.8 · Injection site reactions Injection site reactions (including injection site haematoma, pain, haemmorrhage, ery
Eintrag öffnenXultophy · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenXultophy · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenXultophy · 4.8 · Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous am
Eintrag öffnenXultophy · 4.8 · Summary of the safety profile
Eintrag öffnenXultophy · 4.8 · Table 1 Adverse reactions reported in phase 3 controlled studies MedDRA System organ class Frequency Adverse r
Eintrag öffnenXultophy · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenXultophy · 4.8 · The Xultophy clinical development programme included approximately 1 900 patients treated with Xultophy.
Eintrag öffnenXultophy · 4.8 · The most frequently reported adverse reactions during treatment with Xultophy were hypoglycaemia and gastroint
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