Ryzodeg

Insulin degludec 70%, insulin aspart 30%

DM in adults, adolescents & childn ≥2 yr.

SC Type 2 DM Initially 10 u followed by individual dose adjustments. Can be administered once daily or bd as monotherapy, in combination w/ oral antidiabetics, & in combination w/ bolus insulin. Type 1 DM Initially 60-70% of the total daily insulin requirements. Use once daily in combination w/ short-/rapid-acting insulin followed by individual dose adjustments.

Should be taken with food.

Hypersensitivity.

Do not administer by IV or IM. Do not use in insulin infusion pumps. Do not draw from the cartridge of the pre-filled pen into a syringe. Always rotate inj sites w/in the same region to reduce risk of lipodystrophy & cutaneous amyloidosis. Blood glucose monitoring is recommended after change in the inj site from an affected area (inj site w/ lipodystrophy, cutaneous amyloidosis) to an unaffected area, & dose adjustment of antidiabetic medications may be considered. Risk of hypoglycaemia w/ excessive insulin dose, omitted meal, or unplanned, strenuous physical exercise. May be associated w/ higher occurrence of severe hypoglycaemia compared to a basal-bolus regimen in paed population, particularly in childn 2-5 yr. Change in usual warning symptoms of hypoglycaemia in patients w/ greatly improved blood glucose control (eg, by intensified insulin therapy); disappearance of usual warning symptoms in patients w/ longstanding diabetes. Dose adjustment may be necessary if patients undertake increased physical activity, change their usual diet, or during concomitant illness (especially infections & fever; concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland); when transferring from other insulin medicinal products. Prolonged effect of Ryzodeg may delay recovery from hypoglycaemia. Risk of hyperglycaemia & diabetic ketoacidosis w/ inadequate dosing or treatment discontinuation. Close glucose monitoring is recommended when transferring from other insulin medicinal products & in the following wk thereafter. Reports of cardiac failure when used in combination w/ thiazolidinediones, especially in patients w/ risk factors for development of cardiac heart failure. Intensification of insulin therapy w/ abrupt improvement in glycaemic control may be associated w/ temporary worsening of diabetic retinopathy. Insulin Ab formation. May impair ability to drive or use machine. Pregnancy & lactation. Intensify glucose monitoring & adjust insulin dose on an individual basis in patients w/ renal or hepatic impairment, & the elderly. No clinical experience in childn <2 yr.

Hypoglycaemia. Inj site reactions.

Reduced patient's insulin requirements w/ oral antidiabetics, GLP-1 receptor agonists, MAOIs, β-blockers, ACE inhibitors, salicylates, anabolic steroids & sulfonamides. Increased patient's insulin requirements w/ OCs, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone & danazol. β-blockers may mask symptoms of hypoglycaemia. Increased/decreased insulin requirements w/ octreotide/lanreotide. Intensified/reduced hypoglycaemic effects of insulin w/ alcohol.

Insulin Preparations

A10AD06 - insulin degludec and insulin aspart ; Belongs to the class of intermediate-acting combined with fast-acting insulins and analogues. Used in the treatment of diabetes.

P₁