Finished product reference

Insulin Degludec / Insulin Aspart

Injection, Solution · Parenteral · 70 IU/30 IU/1mL · 3 mL

List code
52918
Pharmacologic class
Antidiabetic: co-formulation of ultra-long-acting basal insulin and rapid-acting insulin analogue

What it is and how it works

A soluble co-formulation of 70% insulin degludec and 30% insulin aspart. Insulin degludec forms soluble multihexamers after subcutaneous injection, giving a flat, ultra-long basal action, while insulin aspart is rapidly absorbed to cover prandial glucose rises; both lower blood glucose by stimulating peripheral glucose uptake and inhibiting hepatic glucose output.

Indications

Treatment of diabetes mellitus in adults, adolescents and children from 2 years.

Dosage and administration (summary)

Subcutaneous injection once or twice daily with a main meal (the meal may be changed); dose individualised according to glycaemic monitoring. Must not be given intravenously or used in insulin pumps.

Contraindications

Hypersensitivity to the active substances or excipients; hypoglycaemia.

Warnings and precautions

Hypoglycaemia is the most common adverse effect; omission of meals or unplanned exercise increases the risk. Rotate injection sites within the same region to reduce lipodystrophy and cutaneous amyloidosis. Combination with pioglitazone may cause fluid retention and heart failure; hypokalaemia may occur.

Pregnancy

Clinical experience in pregnancy is limited; intensified glucose control and monitoring are recommended if used.

Storage and supply

Before first use store at 2–8 °C; do not freeze. In use, keep below 30 °C for up to 4 weeks; protect from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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