Product Description

Fast-Insulin  is a mealtime insulin for subcutaneous administration up to 2 minutes before the start of the meal, with the option to administer up to 20 minutes after starting the meal (see section 5.1).

Dosing with Fast-Insulin  is individual and determined in accordance with the needs of the patient. Fast-Insulin  given by subcutaneous injection should be used in combination with intermediate-acting or long-acting insulin given at least once a day. In a basal-bolus treatment regimen approximately 50% of this requirement may be provided by Fast-Insulin  and the remaining by intermediate-acting or long-acting insulin.

The individual total daily insulin requirement in adults, adolescents and children may vary and is usually between 0.5 and 1.0 unit/kg/day.

Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.

Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness. Blood glucose levels should be monitored adequately under these conditions.

The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

Patients on basal-bolus treatment who forget a mealtime dose are advised to monitor their blood glucose level to decide if an insulin dose is needed. Patients should resume their usual dosing schedule at the next meal.

The potency of insulin analogues, including Fast-Insulin , is expressed in units. One (1) unit of Fast-Insulin  corresponds to 1 international unit of human insulin or 1 unit of other fast-acting insulin analogues.

The early onset of action must be considered when prescribing Fast-Insulin  (see section 5.1).

Initiation

Patients with type 1 diabetes mellitus

The recommended starting dose in insulin naïve patients with type 1 diabetes is approximately 50% of the total daily insulin dose and should be divided between the meals based on the size and composition of the meals. The remainder of the total daily insulin dose should be administered as intermediate-acting or long-acting insulin. 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 naïve patients with type 1 diabetes.

Patients with type 2 diabetes mellitus

Suggested initial dose is 4 units at one or more meals. Number of injections and subsequent titration will depend on the individual glycaemic target and the size and composition of the meals.

Dose adjustment may be considered daily based on self-measured plasma glucose (SMPG) on the previous day(s) according to Table 1.

• Pre-breakfast dose should be adjusted according to the pre-lunch SMPG the previous day

• Pre-lunch dose should be adjusted according to the pre-dinner SMPG the previous day

• Pre-dinner dose should be adjusted according to the bedtime SMPG the previous day