Abbreviated Prescribing Information: Insulin degludec/insulin aspart - Ryzodeg™ FlexTouch^®: Consult Pack Insert before prescribing. Ryzodeg™ (insulin degludec/insulin aspart) 100 units/mL insulin solution for subcutaneous injection in a pre-filled pen (FlexTouch^®). Presentation: Ryzodeg™ FlexTouch^®. 1mL solution contains 100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart). One pre-filled device contains 300 units of Ryzodeg™ in 3 mL solution. Indications: Treatment of diabetes mellitus in adults. Posology and administration: Ryzodeg^™ can be administered once- or twice-daily with the main meal(s). In patients with type 2 diabetes mellitus, Ryzodeg™ can be administered alone, in combination with oral anti-diabetic medicinal products, and in combination with bolus insulin. In type 1 diabetes mellitus, Ryzodeg™ is combined with short-/rapid-acting insulin at the remaining meals. Administration by subcutaneous injection only. Ryzodeg™ should be dosed in accordance with individual patient needs. Dose adjustments are recommended to be primarily based on FPG measurements. Ryzodeg™ allows for flexibility in the timing of insulin administration as long as it is dosed with the main meal(s). In older patients and patients with renal and/or hepatic impairment, glucose-monitoring should be intensified and the insulin dose adjusted on an individual basis. The safety and efficacy of Ryzodeg™ in children and adolescents below 18 years of age have not been established. Ryzodeg™ comes in a pre-filled pen (FlexTouch^®) designed to be used with NovoFine^® injection needles. The prefilled pen delivers 1–80 units in steps of 1 unit. Patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between Ryzodeg™ and other insulin products. Patients must visually verify the dialled units on the dose counter of the pen or get help/assistance from another person who has good vision and is trained in using the insulin device. Contraindications: Hypersensitivity to the active substances or any of the excipients. Special warnings and precautions: Too high insulin dose, omission of a meal or unplanned strenuous physical exercise may lead to hypoglycaemia. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement. When using insulin in combination with pioglitazone, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Hypoglycaemia may constitute a risk when driving or operating machinery. Pregnancy and lactation: There is no clinical experience with use of Ryzodeg™ in pregnant women or in those who are breastfeeding. Undesirable effects: Refer to pack insert for complete information on side effects. 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). Very common: Hypoglycaemia. Common: Injection site reactions. Not known: Lipodystrophy. Uncommon: Peripheral oedema and rare: Hypersensitivity and urticaria. With insulin preparations, allergic reactions may occur; immediate-type allergic reactions may potentially be life threatening. Injection site reactions are usually mild, transitory and normally disappear during continued treatment. Manufactured by: Novo Nordisk A/S, Novo Alle, DK-2880 Bagsvaerd, Denmark. Imported by: Novo Nordisk India Private Limited, Plot No. 32, 47 - 50,EPIP Area, White field, Bangalore - 560066. To be sold by retail on the prescription of registered Endocrinologist and/or MD (Internal Medicine) treating diabetic patients only. Ryzodeg™, FlexTouch^® and NovoFine^® are trademarks owned by Novo Nordisk A/S,Denmark. Please refer latest pack insert for more details.