Summary of the safety profile: The most frequently reported adverse reaction during treatment is hypoglycaemia (see Description of selected adverse reactions as follows).
Tabulated list of adverse reactions: Adverse reactions listed as follows are based on clinical trial data and classified according to MedDRA System Organ Class. Frequency categories are defined according to the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data). (See Table 4.)
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Description of selected adverse reactions: Immune system disorders: With insulin preparations, allergic reactions may occur. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening.
With Ryzodeg, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Hypoglycaemia: Hypoglycaemia may occur if the insulin dose is too high in relation to the insulin requirement. Severe hypoglycaemia may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death. The symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Lipodystrophy: Lipodystrophy (including lipohypertrophy, lipoatrophy) may occur at the injection site. Continuous rotation of the injection site within the particular injection area may help to reduce the risk of developing these reactions.
Injection site reactions: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Ryzodeg. These reactions are usually mild and transitory and they normally disappear during continued treatment.
Paediatric population: Ryzodeg has been administered to children and adolescents up to 18 years of age for the investigation of pharmacokinetic properties (see Pharmacology: Pharmacokinetics under Actions). 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 Dosage & Administration, Precautions and Pharmacology: Pharmacodynamics under Actions).
Other special populations: Based on results from clinical trials, the frequency, type and severity of adverse reactions observed in the elderly and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.