Nebenwirkungen · Ryzodeg
Ryzodeg 100 units/mL FlexTouch solution for injection in pre-filled pen Ryzodeg 100 units/mL FlexPen solution for injection in pre-filled pen Ryzodeg 100 units/mL Penfill solution for injection in cartridge · Abschnitt 4.8 · PDF-Seite 8
HOS-126599 · Präparat HOS-096285
Paediatric population Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see section 5.2). Safety and efficacy have been demonstrated in a trial in children aged 2 to less than 18 years. The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population with the exception of a signal of higher occurrence of severe hypoglycaemia compared to a basal- bolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 4.2, 4.4 and 5.1).
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Version 2024-05-13T01:00:00Z · SHA-256 df86c897629e7225a3f88c7dfc6b236d532d632db8a5b3a5204db17fb07d7e2e · Passage 8c15bf5a1289520df995739a24bb9c8c2eded70ba5d6c1b7f14b354b090a60d6 · Zeichen 3072–3719 im Abschnitt