NovoRapid Dosage/Direction for Use

Posology: The potency of insulin analogues, including insulin aspart, is expressed in units (U), whereas the potency of human insulin is expressed in international units.
NovoRapid dosing is individual and determined in accordance with the needs of the patient. It should normally be used in combination with intermediate-acting or long-acting insulin. Blood glucose monitoring and insulin dose adjustment are recommended to achieve optimal glycaemic control.
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 U/kg/day. In a basal-bolus treatment regimen, 50-70% of this requirement may be provided by NovoRapid and the remainder by intermediate-acting or long-acting insulin. Adjustment of dosage may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Special populations: Elderly (≥65 years old): NovoRapid can be used in elderly patients.
In elderly patients, glucose monitoring should be intensified and the insulin aspart 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 insulin aspart dose adjusted on an individual basis.
Paediatric population: NovoRapid can be used in children and adolescents aged 1 year and above in preference to soluble human insulin when a rapid onset of action might be beneficial, for example, in the timing of the injections in relation to meals (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions). The safety and efficacy of NovoRapid in children below 1 year of age have not been established. No data are available.
Transfer from other insulin medicinal products: When transferring from other insulin medicinal products, adjustment of the NovoRapid dose and the dose of the basal insulin may be necessary. NovoRapid has a faster onset and a shorter duration of action than soluble human insulin. When injected subcutaneously into the abdominal wall, the onset of action will occur within 10-20 minutes of injection. The maximum effect is exerted between 1 and 3 hours after the injection. The duration of action is 3 to 5 hours. Close glucose monitoring is recommended during the transfer and in the initial weeks thereafter (see Precautions).
Method of administration: NovoRapid is a rapid-acting insulin analogue. NovoRapid is administered subcutaneously by injection in the abdominal wall, the thigh, the upper arm, the deltoid region or the gluteal region. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see Precautions and Adverse Reactions). Subcutaneous injection in the abdominal wall ensures a faster absorption than other injection sites. Compared to soluble human insulin the faster onset of action of NovoRapid is maintained regardless of the injection site. The duration of action will vary according to the dose, injection site, blood flow, temperature and level of physical activity. Due to the faster onset of action, NovoRapid should generally be given immediately before a meal. When necessary NovoRapid can be given soon after a meal.
NovoRapid 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 U in increments of 1 U.
NovoRapid FlexPen is colour-coded and accompanied by a package leaflet with detailed instructions for use to be followed.
NovoRapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Intravenous use: NovoRapid may be administered intravenously under medical supervision. For emergency use with FlexPen or Penfill, the NovoRapid must first be withdrawn into a syringe. Discard pen or cartridge after emergency use. NovoRapid has been used intravenously. No studies have been conducted in critically ill people with diabetes who are likely to require intravenous administration. There is no pharmacokinetic or pharmacodynamic advantage in using NovoRapid over soluble human insulin when these insulins are given intravenously.
For intravenous use, infusion systems with NovoRapid 100 U/ml at concentrations from 0.05 U/ml to 1.0 U/ml insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose including 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 be initially adsorbed to the infusion bag. Monitoring of blood glucose is necessary during insulin infusion.