Active Ingredient: Insulin glargine
Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 0.2 international units insulin glargine per kilogram of body weight, once daily.
Insulin glargine is a basal insulin for once-daily administration at any time of the day, preferably at the same time every day.
The dose regimen (dose and timing) should be adjusted according to individual response.
In type 1 diabetes mellitus, insulin glargine must be combined with short-/rapid-acting insulin to cover mealtime insulin requirements.
In patients with type 2 diabetes mellitus, insulin glargine can also be given together with other anti-hyperglycaemic medicinal products.
The potency of this medicinal product is stated in units. These units are exclusive to insulin glargine and are not the same as IU or the units used to express the potency of other insulin analogues.
When needed, patients can administer insulin glargine up to 3 hours before or after their usual time of administration.
Patients who forget a dose, should be advised to check their blood sugar and then resume their usual once-daily dosing schedule. Patients should be informed not to inject a double dose to make up for a forgotten dose.
Insulin glargine is to be used once-daily with meal-time insulin and requires individual dose adjustments.
The recommended daily starting dose is 0.2 units/kg followed by individual dose adjustments.
In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Insulin glargine can be used in adolescents and children from the age of 6 years based on the same principles as for adult patients. When switching basal insulin to insulin glargine, dose reduction of basal and bolus insulin needs to be considered on an individual basis, in order to mimimize the risk of hypoglycaemia.
The safety and efficacy of insulin glargine in children below 6 years of age have not been established. No data are available.
Insulin glargine is administered subcutaneously by injection in the abdominal wall, the deltoid or the thigh. Injection sites must be rotated within a given injection area from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.
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