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10 ml X 100 IU/ml
The potency of human insulin is expressed in international units.
Insulatard® dosing is individual and determined in accordance with the needs of the patient. The physician determines whether one or several daily injections are necessary. Insulatard® may be used alone or mixed with fast-acting insulin. In intensive insulin therapy the suspension may be used as basal insulin (evening and/or morning injection) with fast-acting insulin given at meals. Blood
glucose monitoring is recommended to achieve optimal glycaemic control.
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.
Elderly (≥ 65 years old): Insulatard® 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: Insulatard® can be used in children and adolescents.
Transfer from other insulin medicinal products: When transferring from other intermediate or long-acting insulin medicinal products, adjustment of the Insulatard® dose and timing of administration may be necessary.
Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter.
Method of administration
Insulatard® is a human insulin with gradual onset and long duration of action.
Insulatard® is administered subcutaneously by injection in the thigh, the abdominal wall, the gluteal region or the deltoid region. Insulin suspensions are never to be administered intravenously. 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. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy. Subcutaneous injection into the thigh results in a slower and less variable absorption compared to the other injection sites. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity.
Insulin suspensions are not to be used in insulin infusion pumps.
For detailed user instructions, please refer to the package leaflet.
Insulatard® vial (100 international units/ml): Administration with a syringe:
Insulatard® vials are for use with insulin syringes with a corresponding unit scale.
Insulatard® Penfill®: Administration with an insulin delivery system:
Insulatard® Penfill® is designed to be used with Novo Nordisk insulin delivery systems and NovoFine® or NovoTwist® needles.
Insulatard® is indicated for treatment of diabetes mellitus.
Hypersensitivity to the active substance or to any of the excipients.
See prescribing information for full details.
The most frequently reported adverse reaction during treatment is hypoglycaemia. The frequencies of hypoglycaemia vary with patient population, dose regimens and level of glycaemic control.
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 a 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 sulfonamides.
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 Insulatard® during breast-feeding. Insulin treatment of the nursing mother presents no risk to the baby. However, the Insulatard® 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
Incompatibilities: Insulin medicinal products should only be added to compounds with which it is known to be compatible. Insulin suspensions should not be added to infusion fluids.
Shelf life: Before opening: 30 months.
During use or when carried as a spare: The product can be stored for a maximum of 6 weeks. Store below 25°C.
Storage: Before opening: Store in a refrigerator (2°C – 8°C). Do not freeze.
During use or when carried as a spare: Store below 25°C. Do not refrigerate or freeze. Keep the vial in the outer carton in order to protect from light.