Presentation and Status in Health Basket
Cartridge (solution for injection)
PENFILL: 3 ml
The potency of human insulin is expressed in international units (iu).
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 iu/kg/day. The daily insulin requirement may be higher in patients with insulin resistance (e.g. during puberty or due to obesity) and lower in patients with residual, endogenous insulin production.
In patients with diabetes mellitus optimised glycaemic control delays the onset of late diabetic complications. Close blood glucose monitoring is therefore recommended. Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Elderly (≥ 65 years old): Actrapid® can be used in elderly patients.
As with all insulin medicinal products, 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.
As with all insulin medicinal products, 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.
Method of administration: See prescribing information for full details.
Treatment of diabetes mellitus.
Hypersensitivity to the active substance or to any of the excipients.
See prescribing information for full details.
At the beginning of the insulin treatment, refraction anomalies, oedema and injection site reactions (pain, redness, hives, inflammation, bruising, swelling and itching at the injection site) may occur.
These reactions are usually of transitory nature. Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible. Intensification of insulin therapy with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycaemic control decreases the risk of progression of diabetic retinopathy.
See prescribing information for full details.
A number of medicinal products are known to interact with glucose metabolism.
The following substances may reduce the patient’s insulin requirement:
Oral antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
The following substances may increase the patient’s insulin requirement:
Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormone and danazol.
Beta-blockers may mask the symptoms of hypoglycaemia.
Octreotide/lanreotide may either increase or decrease the insulin requirement.
Alcohol may intensify or reduce the hypoglycaemic effect of insulin.
Pregnancy and Lactation
Pregnancy: There are no restrictions on treatment of diabetes with insulin during pregnancy, as insulin does not pass the placental barrier.
Both hypoglycaemia and hyperglycaemia, which can occur in inadequately controlled diabetes therapy, increase the risk of malformations and death in utero. Intensified blood glucose control and monitoring of pregnant women with diabetes are recommended throughout pregnancy and when contemplating pregnancy. Insulin requirements usually fall in the first trimester and increase
subsequently during the second and third trimesters. After delivery, insulin requirements normally return rapidly to pre-pregnancy values.
Breast-feeding: There is no restriction on treatment with Actrapid® during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the Actrapid® dose may need to be adjusted.
A specific overdose of insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high a dose relative to the patient’s requirement is administered:
• Mild hypoglycaemic episodes can be treated by oral administration of glucose or sugary products. It is therefore recommended that the diabetic patient always carries sugar-containing products.
• Severe hypoglycaemic episodes, where the patient has become unconscious, can be treated with glucagon (0.5 to 1 mg) given intramuscularly or subcutaneously by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously, if the patient does not respond to glucagon within 10 to 15 minutes.
Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.