Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Novo Nordisk A/S, Novo Allé, DK-2880, Bagsværd, Denmark
NovoRapid is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
The potency of insulin analogues, including insulin aspart, is expressed in units, 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.
Moreover NovoRapid vial and NovoRapid PumpCart can be used for continuous subcutaneous insulin infusion (CSII) in pump systems.
NovoRapid vial can also be used if intravenous administration of insulin aspart, by physicians or other healthcare staff, is applicable.
Blood glucose monitoring and insulin dose adjustments are recommended to achieve optimal glycaemic control.
The individual insulin requirement in adults and children is usually between 0.5 and 1.0 unit/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 dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
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 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.
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 sections 5.1 and 5.2).
The safety and efficacy of NovoRapid in children below 1 year of age have not been established. No data are available.
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 section 4.4).
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. 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 may be used for CSII in pump systems suitable for insulin infusion. CSII should be administered in the abdominal wall. Infusion sites should be rotated.
When used with an insulin infusion pump, NovoRapid should not be mixed with any other insulin medicinal products.
Patients using CSII should be comprehensively instructed in the use of the pump system and use the correct reservoir and tubing for the pump (see section 6.6). The infusion set (tubing and cannula) should be changed in accordance with the instructions in the product information supplied with the infusion set.
Patients administering NovoRapid by CSII must have an alternative insulin delivery method available in case of pump system failure.
If necessary, NovoRapid can be administered intravenously which should be carried out by physicians or other healthcare staff.
For intravenous use, infusion systems with NovoRapid 100 units/ml at concentrations from 0.05 unit/ml to 1.0 unit/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 material of the infusion bag. Monitoring of blood glucose is necessary during insulin infusion.
NovoRapid can only be mixed with NPH (Neutral Protamine Hagedorn) insulin in a syringe for subcutaneous use. When NovoRapid is mixed with NPH insulin, NovoRapid should be drawn into the syringe first, and the mixture should be injected immediately after mixing. Insulin mixtures should not be administered intravenously or used with a subcutaneous insulin infusion pump.
NovoRapid vials are for use with insulin syringes with the corresponding unit scale. See also section 6.2.
NovoRapid Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles. NovoRapid 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. If administration by infusion pump is necessary, a vial or NovoRapid PumpCart should be used.
NovoRapid FlexPen is a pre-filled pen (colour-coded) 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. NovoRapid FlexPen is only suitable for subcutaneous injections. If administration by syringe or intravenous injection is necessary, a vial should be used. If administration by infusion pump is necessary, a vial or NovoRapid PumpCart should be used.
NovoRapid 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. NovoRapid InnoLet is only suitable for subcutaneous injections. If administration by syringe or intravenous injection is necessary, a vial should be used. If administration by infusion pump is necessary, a vial or NovoRapid PumpCart should be used.
NovoRapid FlexTouch is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexTouch delivers 1-80 units in increments of 1 unit. NovoRapid FlexTouch is only suitable for subcutaneous injections. If administration by syringe or intravenous injection is necessary, a vial should be used. If administration by infusion pump is necessary, a vial or NovoRapid PumpCart should be used.
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. CSII should be administered in the abdominal wall. Infusion sites should be rotated. NovoRapid PumpCart is only suitable for CSII in pump systems suitable for insulin infusion. If administration by syringe or intravenous injection is necessary, a vial should be used.
For detailed user instructions, please refer to the package leaflet.
A specific overdose for insulin cannot be defined, however, hypoglycaemia may develop over sequential stages if too high doses relative to the patient’s requirement are administered:
Before opening: 30 months.
NovoRapid vial/NovoRapid Penfill/NovoRapid FlexPen/NovoRapid InnoLet/NovoRapid FlexTouch: During use or when carried as a spare: The product must be stored for a maximum of 4 weeks. Store below 30°C.
NovoRapid PumpCart: During use or when carried as a spare: NovoRapid PumpCart carried as a spare can be kept for up to 2 weeks below 30°C. Thereafter it can be used for up to 7 days below 37°C in an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
For storage conditions of the medicinal product, see section 6.3.
Before opening: Store in a refrigerator (2°C-8°C). Do not freeze.
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. Keep the vial/cartridge in the outer carton in order to protect from light.
During use or when carried as a spare: Store below 30°C. Can be stored in a refrigerator (2°C-8°C). Do not freeze.
Keep the pen cap on the pen in order to protect from light.
During use or when carried as a spare: Store below 30°C. Do not refrigerate. Do not freeze. Keep the pen cap on the pen in order to protect from light.
During use or when carried as a spare: Store below 37°C (in use) or store below 30°C (carried as a spare). Do not refrigerate. Do not freeze.
Keep the cartridge in the outer carton in order to protect from light.
NovoRapid vial: 10 ml solution in vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap.
Pack sizes of 1 or 5 vials of 10 ml or a multipack containing 5 packs of 1 × 10 ml vial. Not all pack sizes may be marketed.
NovoRapid Penfill: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Pack sizes of 5 and 10 cartridges. Not all pack sizes may be marketed.
NovoRapid FlexPen: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) and 10 (without needles) pre-filled pens.
Not all pack sizes may be marketed.
NovoRapid InnoLet: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained 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.
NovoRapid FlexTouch: 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 × 5 (without needles) pre-filled pens of 3 ml. Not all pack sizes may be marketed.
NovoRapid PumpCart: 1.6 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure (bromobutyl/polyisoprene).
Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges. 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.
NovoRapid which has been frozen must not be used.
The patient should be advised to discard the needle after each injection.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Needles, syringes, cartridges, pre-filled pens and infusion sets must not be shared. The cartridge must not be refilled.
NovoRapid may be used in an infusion pump system (CSII) as described in section 4.2. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
NovoRapid PumpCart is a pre-filled cartridge ready for use directly in the pump. Please refer to the package leaflet where detailed instructions for use are provided.
To ensure correct dosing, NovoRapid PumpCart must not be used in an insulin pen.
NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps, as described in section 4.2. Tubings in which the inner surface materials are made of polyethylene or polyolefin have been evaluated and found compatible with pump use.
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