The following adverse reactions observed from Toujeo and Lantus from clinical investigations are listed below by system organ class and in order of decreasing incidence common: very common: to <1/10; uncommon: to <1/100; rare: ≥1/10; ≥1/100 ≥1/1,000 to <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available ≥1/10,000 data. Within each frequency grouping, adverse reactions are presented in of decreasing seriousness. Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. Table 7 reactions observed from Toujeo Clinical investigations MedDRA Very Common Uncommon Rare Very system common rare organ classes Immune system Allergic disorders reactions Metabolism and Hypoglycaemia nutrition disorders Nervous Dysgeusia system disorders Eyes disorders Visual impairment Retinopathy Skin and Lipoatrophy subcutaneous tissue disorders Musculoskeletal Myalgia and connective tissue disorders General Injection site Oedema disorders and reactions administration site conditions
The following adverse reactions observed from Toujeo and Lantus from clinical investigations are listed below by system organ class and in order of decreasing incidence 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; not known: cannot be estimated from the available data. Within each frequency grouping, adverse reactions are presented in of decreasing seriousness. Hypoglycaemia, in general the most frequent adverse reaction of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement. Table 7 reactions observed from Toujeo Clinical investigations MedDRA system organ classes Very common Common Uncommon Rare Very rare Immune system disorders Allergic reactions Metabolism and nutrition disorders Hypoglycaemia Nervous system disorders Dysgeusia Eyes disorders Visual impairment Retinopathy Skin and subcutaneous tissue disorders Lipoatrophy Musculoskeletal and connective tissue disorders Myalgia General disorders and administration site conditions Injection site reactions Oedema
auspar-insulin-glargine-rbe-170106-pi.docx