Ryzodeg 100 IU/ml (SC Injection)

Indications

• Improve glycemic control in patients 1 year of age and older with diabetes mellitus

Pharmacology

• Binds specifically to the human insulin receptor
• Results in the same pharmacological effects as human insulin
• Facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells
• Inhibition of glucose output from the liver

Dosage

• Consists of basal insulin degludec and rapid-acting prandial insulin aspart
• Dosed in accordance with the individual patient's needs
• Dose-adjustments based on fasting plasma glucose measurements
• Recommended total daily starting dose for type 2 diabetes mellitus: 10 units with meal(s)
• Recommended starting dose for type 1 diabetes mellitus: 60-70% of the total daily insulin requirements

Administration

• Can be administered once- or twice-daily with the main meal(s)
• Can be administered alone or in combination with oral anti-diabetic medicinal products
• Combined with short-/rapid-acting insulin at the remaining meals for type 1 diabetes mellitus

Interaction

• No known drug interactions documented

Contraindications

• Hypersensitivity to the active substances or to any of the excipients

Side Effects

• Hypoglycemia
• Allergic reactions
• Injection site reactions
• Lipodystrophy
• Pruritus
• Rash
• Edema
• Weight gain

Pregnancy & Lactation

• Pregnancy Category C, potential benefits may warrant use despite potential risks
• Insufficient information on the presence of insulin degludec in human milk or its effects on the breastfed infant

Precautions & Warnings

• Hypoglycaemia risk with omission of a meal or unplanned physical exercise
• Hyperglycaemia risk with inadequate dosing or discontinuation of treatment in patients requiring insulin
• Temporary worsening of diabetic retinopathy with abrupt improvement in glycaemic control
• Instructions to avoid accidental mix-ups between this and other insulin products
• Intensified glucose-monitoring and individual insulin dose adjustments for older patients and patients with renal or hepatic impairment

Use in Special Populations

• Can be used in renal and hepatic impaired patients

Therapeutic Class

• Combination Insulin

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