Posology : מינונים

4.2     Posology and method of administration

Posology
The potency of human insulin is expressed in international units.

Actrapid dosing is individual and determined in accordance with the needs of the patient. It can be used alone or in combination with intermediate-acting or long-acting insulin before a meal or a snack.

The individual insulin requirement is usually between 0.3 and 1.0 international unit/kg/day.
Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.

Special populations

Elderly (≥ 65 years old)
Actrapid can be used in elderly patients.
In elderly patients, glucose monitoring should be intensified and the insulin dose adjusted on an individual basis.

Renal and hepatic impairment
Renal or hepatic impairment may reduce the patient’s insulin requirements.
In patients with renal or hepatic impairment, glucose monitoring should be intensified and the human insulin dose adjusted on an individual basis.

Paediatric population
Actrapid can be used in children and adolescents.

Transfer from other insulin medicinal products
When transferring from other insulin medicinal products, adjustment of the Actrapid dose and the dose of the basal insulin may be necessary.

Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see section 4.4).

Method of administration

Actrapid is a fast-acting human insulin and may be used in combination with intermediate or long- acting insulin medicinal products.

Actrapid is administered subcutaneously by injection in the abdominal wall, the thigh, the gluteal region or the deltoid region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8). Injection into a lifted skin fold minimises the risk of unintended intramuscular injection.

The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Subcutaneous injection into the abdominal wall ensures a faster absorption than other injection sites.
The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.

An injection should be followed within 30 minutes by a meal or snack containing carbohydrates.

Due to the risk of precipitation in pump catheters, Actrapid should not be used in insulin pumps for continuous subcutaneous insulin infusion.

Actrapid vial (100 international units/ml)
Intravenous use

If necessary, Actrapid can be administered intravenously. This should be carried out by healthcare professionals.

For intravenous use, infusion systems with Actrapid at concentrations from 0.05 international unit/ml to 1.0 international unit/ml human insulin in the infusion fluids 0.9% sodium chloride, 5% dextrose and 10% dextrose with 40 mmol/l potassium chloride using polypropylene infusion bags, are stable at room temperature for 24 hours. Although stable over time, a certain amount of insulin will initially be adsorbed to the material of the infusion bag. Monitoring of blood glucose is necessary during the insulin infusion.

For detailed user instructions, please refer to the package leaflet.

Administration with a syringe
Actrapid vials are for use with insulin syringes with a corresponding unit scale. When two types of insulin are mixed always mix the insulin medicinal products in the same sequence.

Actrapid Penfill
Administration with an insulin delivery system
Actrapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles. Actrapid Penfill is only suitable for subcutaneous injections from a reusable pen.
If administration by syringe or intravenous injection is necessary, a vial should be used.