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NovoRapid PumpCart 100 units/ml solution for injection in cartridge
NovoRapid® PumpCart®100 units/ml solution for injection in cartridge
insulin aspart
1. What NovoRapid® PumpCart® is and what it is used for
2. What you need to know before you use NovoRapid® PumpCart®
3. How to use NovoRapid® PumpCart®
4. Possible side effects
5. How to store NovoRapid® PumpCart®
6. Contents of the pack and other information
NovoRapid® is a modern insulin (insulin analogue) with a rapid-acting effect. Modern insulin products are improved versions of human insulin.
NovoRapid® is used to reduce the high blood sugar level in adults, adolescents and children aged 1 year and above with diabetes mellitus (diabetes). Diabetes is a disease where your body does not produce enough insulin to control the level of your blood sugar. Treatment with NovoRapid® helps to prevent complications from your diabetes.
NovoRapid® PumpCart® is for use in a pump and covers your total daily insulin needs: both your all day (basal) and meal-time (bolus) insulin needs. Before you use NovoRapid® PumpCart® in the pump you must have received a comprehensive instruction by your doctor or nurse.
Basal (all-day) insulin requirements: When you use NovoRapid® PumpCart® in a pump, your insulin will be constantly delivered to cover your basal need for insulin. If you change the basal insulin setting the change will start to affect you within 10-20 minutes. If you stop the pump, the insulin effect will last for 3 to 5 hours. Before you set or change the basal rate, carefully read the pump manual (user guide).
Bolus (meal-time) insulin requirements: NovoRapid® will start to lower your blood sugar within 10-20 minutes after you start a bolus delivery (see section 3, How to use NovoRapid® PumpCart®, for more information about how to adjust your bolus dose). The maximum effect occurs between 1 and 3 hours after the bolus delivery and the effect lasts for 3 to 5 hours.
If any of these applies, do not use NovoRapid® PumpCart®. Talk with your doctor, nurse or pharmacist for advice.
Some conditions and activities can affect your need for insulin. Consult your doctor:
The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3, How to use NovoRapid®). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Do not give this medicine to children below 1 year of age since no clinical studies have been carried out in children below the age of 1 year.
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines affect your blood sugar level and this may mean that your insulin dose has to change. Listed below are the most common medicines which may affect your insulin treatment.
Your blood sugar level may fall (hypoglycaemia) if you take:
Your blood sugar level may rise (hyperglycaemia) if you take:
Octreotide and lanreotide (used for treatment of acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused by the pituitary gland producing excess growth hormone) may either increase or decrease your blood sugar level.
Beta-blockers (used to treat high blood pressure) may weaken or suppress entirely the first warning symptoms which help you to recognise low blood sugar.
Pioglitazone (tablets used for the treatment of type 2 diabetes)
Some patients with long-standing type 2 diabetes and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
If you have taken any of the medicines listed here, tell your doctor, nurse or pharmacist.
Ask your doctor, nurse or pharmacist for advice before taking this medicine while pregnant or breast-feeding.
If your blood sugar is low or high, your concentration and ability to react might be affected and therefore also your ability to drive or operate a machine. Bear in mind that you could endanger yourself or others.
NovoRapid® contains less than 1 mmol sodium (23 mg) per dose, i.e. NovoRapid® is essentially ‘sodium-free’.
Always use your insulin and adjust your basal (all-day) and bolus (meal time) doses exactly as your doctor has told you. Check with your doctor, nurse or pharmacist if you are not sure. Your bolus (meal-time) insulin needs to be adjusted based on your blood sugar measurement and food intake. Eat a meal or snack within 10 minutes of the bolus dose to avoid low blood sugar. When necessary, you can take the bolus dose just after you have finished eating.
Do not change your insulin unless your doctor tells you to. If your doctor has switched you from one type or brand of insulin to another, your dose may have to be adjusted by your doctor.
NovoRapid® can be used in adolescents and children aged 1 year and above.
If you have reduced kidney or liver function, or if you are above 65 years of age, you need to check your blood sugar more regularly and discuss changes in your insulin dose with your doctor.
NovoRapid® PumpCart® is only suitable for injecting under the skin (subcutaneously) using a pump. Never inject directly into a vein (intravenously) or muscle (intramuscularly). Speak to your doctor if you need to inject your insulin by another method.
Before using NovoRapid® PumpCart® in a pump, you must have thorough training in the use of the pump and information about any actions to be taken in case of illness, too high or too low blood sugar or failure of the pump. Follow your doctor’s instructions and advice about the use of NovoRapid® PumpCart® in the pump.
Normally you will inject your insulin in the front of your waist (abdomen). Alternatively, if your doctor recommends it, you may use your thigh or upper arm. When you change the infusion set (tubing and needle), be sure to change the site for inserting the needle (injection site). This may reduce the risk of developing lumps or skin pitting (see section 4, Possible side effects). Changing the infusion set must be done according to the instructions in the manual supplied with the infusion set.
It is best to measure your blood sugar level regularly to get the maximum benefit of insulin delivery, and to make sure the pump is working properly. If you experience any problems contact your doctor.
Read carefully the instructions on how to use NovoRapid® PumpCart® included in this package leaflet.
Make sure you have an alternative delivery method for your insulin available for injection under the skin (for example, a pen injector) in case the pump stops working.
If you take too much insulin your blood sugar gets too low (hypoglycaemia). See a) Summary of serious and very common side effects in section 4.
If you forget to take your insulin your blood sugar may get too high (hyperglycaemia). See c) Effects from diabetes in section 4.
Do not stop taking your insulin without speaking with a doctor, who will tell you what needs to be done. This could lead to very high blood sugar (severe hyperglycaemia) and ketoacidosis. See c) Effects from diabetes in section 4.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Low blood sugar (hypoglycaemia) is a very common side effect. It may affect more than 1 in 10 people.
Low blood sugar may occur if you:
Signs of low blood sugar: Cold sweat; cool pale skin; headache; rapid heartbeat; feeling sick; feeling very hungry; temporary changes in vision; drowsiness; unusual tiredness and weakness; nervousness or tremor; feeling anxious; feeling confused; difficulty in concentrating.
Severe low blood sugar can lead to unconsciousness. If prolonged severe low blood sugar is not treated, it can cause brain damage (temporary or permanent) and even death. You may recover more quickly from unconsciousness with an injection of the hormone glucagon by someone who knows how to use it. If you are given glucagon, you will need glucose or a sugar snack as soon as you are conscious. If you do not respond to glucagon treatment, you will have to be treated in a hospital.
What to do if you experience low blood sugar:
Tell relevant people that you have diabetes and what the consequences may be, including the risk of passing out (become unconscious) due to low blood sugar. Let them know that if you pass out, they must turn you on your side and get medical help straight away. They must not give you any food or drink due to risk of suffocation.
Serious allergic reactions to NovoRapid® or one of its ingredients (called a systemic allergic reaction) is a very rare side effect but can potentially be life threatening. It may affect less than 1 in 10,000 people.
Seek medical advice immediately:
Skin changes at the injection site: If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect less than 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.
Uncommon side effects
May affect less than 1 in 100 people.
Signs of allergy: Local allergic reactions (pain, redness, hives, inflammation, bruising, swelling and itching) at the injection site may occur. These usually disappear after a few weeks of taking your insulin. If they do not disappear, or if they spread throughout your body, talk to your doctor immediately. See also Serious allergic reactions above.
Vision problems: When you first start your insulin treatment, it may disturb your vision, but the disturbance is usually temporary.
Swollen joints: When you start taking insulin, water retention may cause swelling around your ankles and other joints. Normally this soon disappears. If not, talk to your doctor.
Diabetic retinopathy (an eye disease related to diabetes which can lead to loss of vision): If you have diabetic retinopathy and your blood sugar level improves very fast, the retinopathy may get worse. Ask your doctor about this.
Rare side effects
May affect less than 1 in 1,000 people.
Painful neuropathy (pain due to nerve damage): If your blood sugar level improves very fast, you may get nerve related pain. This is called acute painful neuropathy and is usually transient.
If you get any side effects, talk with your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via
Great Britain: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
High blood sugar (hyperglycaemia)
High blood sugar may occur if you:
Warning signs of high blood sugar:
The warning signs appear gradually. They include: increased urination; feeling thirsty; losing your appetite; feeling sick (nausea or vomiting); feeling drowsy or tired; flushed; dry skin; dry mouth and a fruity (acetone) smell of the breath.
What to do if you experience high blood sugar:
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge label and carton, after ‘EXP’. The expiry date refers to the last day of that month.
Always keep the cartridge in the outer carton when you are not using it in order to protect it from light. NovoRapid® PumpCart® must be protected from excessive heat and light during storage and use.
Before opening: NovoRapid® PumpCart® that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element. Do not freeze.
During use or when carried as a spare: NovoRapid® PumpCart® in use is not to be kept in the refrigerator. 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 a pump designed to be used with this cartridge, such as the Accu-Chek® Insight and YpsoPump® insulin pumps. Keep NovoRapid® PumpCart® in the blister until use to protect it from damage. Always protect the cartridge from light during use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
NovoRapid® PumpCart® is presented as a solution for injection.
Pack size of 5 cartridges and a multipack containing 25 (5 packs of 5) cartridges of 1.6 ml. Not all pack sizes may be marketed.
The solution is clear and colourless.
Please proceed to the information in ‘Instructions on how to use NovoRapid® PumpCart® pre-filled cartridge’.
This leaflet was last revised in 09/2022
NovoRapid® and PumpCart® are trademarks owned by Novo Nordisk A/S, Denmark
Accu-Chek® is a registered trademark owned by Roche Diagnostics GmbH.
YpsoPump® is a registered trademark owned by the Ypsomed Group.
© 2022
Novo Nordisk A/S
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. It must not be used with other devices not designed for NovoRapid® PumpCart®, as this may result in incorrect insulin dosing and subsequent hyper- or hypoglycaemia.
Please read these instructions carefully before using your NovoRapid® PumpCart®.
Please also read the pump manual (user guide) that comes with your insulin pump.
Pay special attention to these notes as they are important for safe use of NovoRapid® PumpCart®.
1. Before inserting a NovoRapid® PumpCart® cartridge into your pump
Always check that NovoRapid® PumpCart® looks the way it should. See picture A.
Only the top of the plunger should be seen above the white label band. If you suspect NovoRapid® PumpCart® is damaged, take it back to your supplier.
Do not use it if any damage or leakage is seen or if the plunger has moved, making the bottom of the plunger visible above the white label band. This could be a result of leakage of insulin.
Check that the insulin in NovoRapid® PumpCart® is clear and colourless. If the insulin looks cloudy, do not use NovoRapid® PumpCart®. The cartridge may contain a minor amount of air in the form of small bubbles.
2. Inserting a new NovoRapid® PumpCart® cartridge in your pump
Check the pump and cartridge regularly for damages, for example cracks or leakage. If you smell insulin this could also indicate a leakage. Do not use the cartridge if cracks or leakage are seen . Follow the instructions in the pump manual for replacing a cartridge and for cleaning the cartridge compartment in the pump.
Insulin leakage can cause inaccurate dosing and may lead to high blood sugar level. See section 4c of the package leaflet.
During the day and before going to sleep carefully check that your pump is delivering insulin and there are no leakages. Failure of delivery of your insulin may not result in an alert notification from the pump and you may be unaware that there is a problem. You may need to check your blood sugar levels. Tell your doctor or diabetes care team if you suspect a problem with your insulin delivery.
Always make sure you have an alternative delivery method for your insulin available (for example, a pen injector) in case the pump stops working. Seek medical advice if you think you may have very high blood sugars or diabetic ketoacidosis.
3. Removing an empty NovoRapid® PumpCart® cartridge from your pump