Instructions For Use and Handling: NovoRapid is for SC injection or for continuous infusion in a pump system. NovoRapid may also be given IV under close supervision by health care professionals.
For Pump Use: Tubings in which the inner surface materials are made by polyethylene or polyolefin have been evaluated and found compatible with pump use. Although stable over time, a certain amount of insulin will be initially adsorbed to the material of the infusion bag.
For Intravenous Use: Infusion systems with NovoRapid 100 U/mL at concentrations from 0.05-1 U/mL insulin aspart in the infusion fluids 0.9% sodium chloride, 5% dextrose or 10% dextrose inclusive 40 mmol/L potassium chloride using polypropylene infusion bags are stable at room temperature for 24 hrs. Monitoring of blood glucose is necessary during insulin infusion.
Instructions to be given to the Patient:
Penfill: Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine needles.
If the patient is treated with NovoRapid Penfill and another insulin Penfill cartridge, 2 insulin delivery systems should be used, one for each type of insulin.
NovoRapid Penfill is for single person use only.
Check the label to make sure it is the right type of insulin. Always check the cartridge, including the rubber plunger (stopper). Don't use it if any damage is seen or if there is a gap between the rubber plunger and the white label band. Disinfect the rubber membrane with a medicinal swab. Inject the insulin under the skin. Use the injection technique advised by the doctor or diabetes nurse and described in the delivery system manual. Keep the needle under the skin for at least 6 sec to make sure that the full dose has been delivered. After each injection, be sure to discard the needle. Otherwise, the liquid may leak out when the temperature changes.
FlexPen: FlexPen is a dial-a-dose insulin pen. Doses from 1-60 units in increments of 1 unit can be dialed. It is designed to be used with NovoFine S needles of 8 mm or shorter in length. Look for an S on the needle box. The S stands for short cap. As a precautionary measure, always carry a spare insulin delivery device in case FlexPen is lost or damaged.
Getting Started: Check the label to ensure the correct type of insulin. Take off the cap. Disinfect the rubber membrane with a medical swab. Remove the protective tab from a NovoFine S short cap needle. Screw the needle straight and tightly onto FlexPen. Pull off the big outer needle cap and the inner needle cap. Do not discard the big outer needle cap.
Priming to Expel Air Prior to each Injection: small amounts of air may collect in the needle and cartridge during normal use. To avoid injection of air and ensure proper dosing: Dial 2 units. Hold FlexPen with the needle pointing upwards and tap the cartridge gently with the finger a few times to make any air bubbles collect at the top of the cartridge. Keeping the needle upwards, press the push-button all the way in. The dose selector returns to zero. A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times. If a drop of insulin still does not appear, the device is defective and must not be used.
Setting the Dose: Check that the dose selector is set at zero. Dial the number of units needed inject. The dose can be corrected either up or down by turning the dose selector in either direction. When dialing back, be careful not to push the push button as insulin will come out. Do not use the residual scale to measure the dose of insulin. A dose larger than the number of units left in the cartridge cannot be set.
Making the Injection: Insert the needle into the skin. Use injection technique advised by the doctor. Deliver the dose by pressing the push-button all the way in. Be careful only to push the push-button when injecting. Keep the push-button fully depressed after the injection until the needle has been withdrawn from the skin. The needle should remain under the skin for at least 6 sec. Keep the push button fully depressed until the needle is withdrawn from the skin. This will ensure that the full dose has been delivered.
Removing the Needle: Replace the outer needle cap and unscrew the needle. Dispose it carefully. Use a new needle for each injection. Remove the needle after each injection. Otherwise, the liquid may leak out when the temperature changes. Dispose the used FlexPen carefully without the needle attached.
Maintenance: FlexPen is designed to work accurately and safely. It should be handled with care. Clean the exterior of FlexPen by wiping it with a medicinal swab. Do not soak, wash or lubricate it. This may damage the mechanism.
NovoRapid Should Not be Used: If the FlexPen or cartridge or the device containing the cartridge is dropped, damaged or crushed, there is a risk of leakage of insulin; if it has not been stored correctly or if it has been frozen; if the insulin does not appear clear and colourless.
Always vary the site to inject to avoid lumps. The best places to give an injection are: the front of the waist (abdomen); the buttocks; the front of the thighs or upper arms. The insulin will work more quickly if injected around the waist.
For Use in an Infusion Pump System: NovoRapid should never be mixed with any other insulin when use in a pump.
Follow the instructions and recommendations from the doctor regarding the use of NovoRapid in a pump. Before use of NovoRapid in the pump system, a comprehensive instruction in the use and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump system must have been received.
Before inserting the needle, use soap and water to clean the hands and the skin where the needle is inserted so as to avoid any infection at the infusion site; when filling a new reservoir, be certain not to leave large air bubbles in either the syringe or the tubing; changing of the infusion set (tubing and needle) must be done according to the instructions in the product information supplied with the infusion set. To get the benefit of insulin infusion and to detect possible malfunction of the insulin pump, it is recommended to measure the blood sugar level regularly. Always have alternative insulin available for injection under the skin in case of pump system failure.