Active Ingredient: Insulin degludec
Treatment of diabetes mellitus in adults, adolescents and children from the age of 1 year.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, between 0.2 international units insulin degludec per kilogram of body weight and 0.4 international units insulin degludec per kilogram of body weight, once daily to meals.
This medicinal product is a basal insulin for once-daily subcutaneous administration at any time of the day, preferably at the same time every day.
The potency of insulin analogues, including insulin degludec, is expressed in units. One (1) unit of insulin degludec corresponds to 1 international unit of human insulin, 1 unit of insulin glargine (100 units/mL), or 1 unit of insulin detemir.
In type 1 diabetes mellitus, insulin degludec must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
ฮnsulin degludec is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
On occasions when administration at the same time of the day is not possible, insulin degludec allows for flexibility in the timing of insulin administration. A minimum of 8 hours between injections should always be ensured. There is no clinical experience with flexibility in dosing time of insulin degludec in children and adolescents.
Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
ฮnsulin degludec is to be used once daily with mealtime insulin and requires subsequent individual dosage adjustments.
The recommended starting dose in insulin naรฏve patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be administered as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial total daily insulin dose in insulin naรฏve patients with type 1 diabetes.
Close glucose monitoring is recommended during the transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted.
For patients with type 1 diabetes a dose reduction of 20% based on the previous basal insulin dose or basal component of a continuous subcutaneous insulin infusion regimen should be considered with subsequent individual dosage adjustments based on the glycaemic response.
It is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.
To be used once daily with mealtime insulin.
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