Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
Actrapid is indicated for treatment of diabetes mellitus.
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.
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 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.
Actrapid can be used in children and adolescents.
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).
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 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 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.
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.
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 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.
Actrapid InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit. Actrapid InnoLet is only suitable for subcutaneous injections. If administration by syringe or intravenous injection is necessary, a vial should be used.
Actrapid FlexPen is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit. Actrapid FlexPen is only suitable for subcutaneous injections. If administration by syringe or intravenous injection is necessary, a vial should be used.
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:
Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Before opening: 30 months.
During use or when carried as a spare:
The product can be stored for a maximum of 4 weeks. Store below 25°C.
During use or when carried as a spare:
The product can be stored for a maximum of 6 weeks. Store below 25°C.
During use or when carried as a spare:
The product can be stored for a maximum of 6 weeks. Store below 30°C.
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.
During use or when carried as a spare: Store below 30°C. Do not refrigerate or freeze. Keep the cartridge in the outer carton in order to protect from light.
During use or when carried as a spare: Store below 30°C. Do not refrigerate or freeze. Keep the pen cap on the pen in order to protect from light.
Actrapid vial (40 international units/ml)/Actrapid vial (100 international units/ml): Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of solution.
Pack sizes of 1 and 5 vials of 10 ml or a multipack of 5 packs of 1 × 10 ml vial. Not all pack sizes may be marketed.
Actrapid Penfill: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution.
Pack sizes of 1, 5 and 10 cartridges. Not all pack sizes may be marketed.
Actrapid InnoLet/Actrapid FlexPen: Cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) containing 3 ml of solution in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1, 5 and 10 pre-filled pens. Not all pack sizes may be marketed.
Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Actrapid which has been frozen must not be used.
The patient should be advised to discard the needle and syringe after each injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Needles, syringes, cartridges and pre-filled-pens must not be shared.
The cartridge must not be refilled.
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