Product Information for the User

NovoRapid PumpCart 100100 units/mL injectable solution in cartridge

aspart insulin

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

•Keep this product information, as you may need to read it again.

•If you have any questions, consult your doctor, nurse, or pharmacist.

•This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

•If you experience any adverse effects, consult your doctor, nurse, or pharmacist, even if they are not listed in this product information. See section 4.

1.What is NovoRapid PumpCart and how it is used

2.What you need to know before starting to use NovoRapid PumpCart

3.How to use NovoRapid PumpCart

4.Possible adverse effects

5.Storage of NovoRapid PumpCart

6.Contents of the package and additional information

NovoRapid is a modern insulin (insulin analog) with rapid action. Modern insulins are improved versions of human insulin.

NovoRapid is used to reduce high blood sugar levels in adults, adolescents, and children 1 year of age and older with diabetes mellitus (diabetes). Diabetes is a disease in which the body does not produce enough insulin to control blood sugar levels. Treatment with NovoRapid helps to prevent diabetes complications.

NovoRapid PumpCart must be used in a pump. It covers your total daily insulin needs: the insulin needed throughout the day (basal) and the insulin needed at mealtime (bolus). Before using NovoRapid PumpCart in the pump, you must have received a complete training from your doctor or nurse.

Basal insulin needs (throughout the day):When using NovoRapid PumpCart in a pump, insulin is released continuously to cover your basal insulin needs. If you change the basal insulin setting, the change will start to affect you in 10–20 minutes. If you stop the pump, the insulin effect will last 3 to 5 hours. Before setting or changing the basal dose, read the pump manual (user manual) carefully.

Bolus insulin needs (mealtime):NovoRapid will start to lower your blood sugar levels 10–20 minutes after initiating bolus administration (see section 3, How to use NovoRapid PumpCart, for more information on how to adjust your bolus dose). The maximum effect is seen between 1 and 3 hours after bolus administration, and the effect lasts 3 to 5 hours.

No use NovoRapid PumpCart

?If you are allergic to insulin aspart or any of the other components of this medicine (see section 6, Contents of the pack and additional information).

?If you suspect that you are going to have a hypoglycemia (low blood sugar level) (see a) Summary of very common and serious adverse reactions in section 4).

?If the cartridge or the device containing the cartridge has fallen, been damaged or broken.

?If it has not been stored properly or if it has been frozen (see section 5, Storage of NovoRapid PumpCart).

?If the insulin does not have a transparent and colourless appearance.

If any of these circumstances affect you, do not use NovoRapid PumpCart. Consult your doctor, nurse or pharmacist.

Before using NovoRapid PumpCart

?Check the label and make sure that the insulin is the type that you have been prescribed.

?Always check the cartridge, including the rubber stopper at the end of the cartridge. Do not use it if it is damaged, if insulin is leaking, or if the rubber stopper has moved above the white band at the end of the cartridge. This could be the result of insulin leaking. If you suspect that the cartridge is damaged, return it to your supplier.

?Do not share infusion equipment (catheter and needle) or NovoRapid PumpCart.

?NovoRapid PumpCart is only indicated for subcutaneous injection using a pump. Consult your doctor if you need to inject insulin by another method.

Warnings and precautions

Some conditions and activities may affect your insulin requirement. Consult your doctor:

?If you have kidney, liver, adrenal gland, pituitary gland or thyroid gland problems.

?If you are doing more exercise than usual or if you want to change your diet, as this may affect your blood sugar level.

?If you are ill, continue your insulin treatment and consult your doctor.

?If you plan to travel abroad, time zone differences between countries may affect your insulin requirement and administration schedule.

Changes in the skin at the injection site

Rotate the injection site to help prevent changes in the fatty tissue, such as thickening of the skin, shrinking of the skin or lumps under the skin. Insulin may not work well if injected in an area that is thickened, shrunk or lumpy (see section 3, How to use NovoRapid PumpCart). Inform your doctor if you notice any changes in the injection site. Inform your doctor if you are currently injecting in these affected areas, before starting to inject in a different area. Your doctor may advise you to check your blood sugar levels more closely, and adjust your insulin or your other diabetes medications.

Children and adolescents

Do not administer this medicine to children under 1 year of age, as there have been no clinical studies in children under 1 year.

Other medicines and NovoRapid

Inform your doctor, nurse or pharmacist if you are using, have used recently or may need to use any other medicine.

Some medicines affect your blood sugar level and this may mean that you need to change your insulin dose. The following are the main medicines that may affect your insulin treatment:

Your blood sugar level may decrease (hypoglycemia) if you take:

•other diabetes medicines;

•monoamine oxidase inhibitors (MAOIs) (used to treat depression);

•beta-blockers (used to treat high blood pressure);

•angiotensin-converting enzyme inhibitors (ACE inhibitors) (used to treat certain heart diseases or high blood pressure);

•salicylates (used to relieve pain and reduce fever);

•anabolic steroids (such as testosterone);

•sulfonamides (used to treat infections).

Your blood sugar level may increase (hyperglycemia) if you take:

•oral contraceptives (birth control pill);

•thiazides (used to treat high blood pressure or fluid retention);

•glucocorticoids (such as "cortisone" used to treat inflammation);

•thyroid hormones (used to treat thyroid gland disorders);

•sympathomimetics (such as adrenaline or salbutamol or terbutaline used to treat asthma);

•growth hormone (medicine to stimulate growth and bone development that has a pronounced effect on metabolic processes);

•danazol (medicine that acts on ovulation).

Octreotide and lanreotide (used to treat acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults, caused when the pituitary gland produces an excess of growth hormone) may increase or decrease your blood sugar levels.

Beta-blockers (used to treat high blood pressure) may weaken or completely suppress the early warning signs that may help you recognize when you have low blood sugar levels.

Pioglitazone (tablets used to treat type 2 diabetes)

Some patients with long-standing type 2 diabetes and pre-existing heart disease or stroke who were treated with pioglitazone and insulin, developed heart failure. Inform your doctor as soon as possible if you have signs of heart failure such as unusual shortness of breath, rapid weight gain or localized inflammation (edema).

If you have taken any of the medicines mentioned above, inform your doctor, nurse or pharmacist.

Alcohol and use of NovoRapid

?If you drink alcohol, it may change your insulin requirement as your blood sugar level may be increased or decreased. It is recommended to have a careful control.

Pregnancy and breastfeeding

?If you are pregnant, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.NovoRapid can be used during pregnancy. You may need to adjust your insulin dose while pregnant and after delivery. It is essential for the health of your baby, a careful control of your diabetes and especially the prevention of hypoglycemia.

• No restrictions on treatment with NovoRapid during lactation.

Consult your doctor, nurse or pharmacist before using this medicine while pregnant or breastfeeding.

Driving and operating machinery

?Please ask your doctor if you can drive or operate machinery:

•If you have frequent hypoglycemia.

•If you find it difficult to recognize hypoglycemia.

If your blood sugar levels are low or high, your concentration and reaction time may be affected and therefore, your ability to drive or operate machinery may also be affected. Please note that you may put your life or the lives of others at risk.

Important information about some of the components of NovoRapid

NovoRapid contains less than 23 mg (1 mmol) of sodium per dose, so NovoRapid is essentially "sodium-free".

Posology and when to administer insulin

Follow exactly the insulin administration instructions and dosage adjustments indicated by your doctor. In case of doubt, consult your doctor, nurse, or pharmacist.Your bolus insulin dose (mealtime), should be adjusted based on your blood glucose measurements and food intake. Take some food within 10 minutes after the bolus dose to prevent hypoglycemia. When necessary, the bolus insulin can be administered immediately after finishing a meal.

Do not change insulin unless your doctor tells you to. If your doctor changes you from one type or brand of insulin to another, you may need to adjust your dosage.

Use in children and adolescents

NovoRapid can be used in adolescents and children aged 1 year and older.

Use in special patient groups

If you have kidney or liver dysfunction, or if you are over 65 years old, you should monitor your blood sugar more frequently and consult with your doctor about changes in your insulin dosage.

How and where to inject

NovoRapid PumpCart is only indicated for subcutaneous injection using a pump. Never inject directly into a vein (intravenously) or into a muscle (intramuscularly). Consult your doctor if you need to inject insulin by another method.

Before using NovoRapid PumpCart with a pump, you should have a solid understanding of pump use and the necessary information about measures to take in case of illness, high or low blood sugar levels, or pump failure. Follow your doctor's instructions and advice on using NovoRapid PumpCart with a pump.

Normally, insulin should be injected in the abdominal area. Alternatively, if your doctor recommends it, you can use the thigh or upper arm. When changing the infusion set (catheter and needle), make sure to change the needle insertion site (injection site). This may reduce the risk of developing skin lumps or depressions (see section 4, Possible adverse effects).

When using an insulin pump

It is best to regularly measure your blood sugar levels to get the maximum benefit from insulin administration and to ensure the pump is working correctly. If you have any problems, consult your doctor.

? NovoRapid PumpCart should only be used with a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.

? NovoRapid PumpCart is a preloaded cartridge ready for direct use in the pump. Follow the pump manual (user manual).

? To ensure correct dosing, NovoRapid PumpCart should not be used in a syringe.

? NovoRapid should not be mixed with any other medication, including other insulins, when used in a pump.

? Do not refill the cartridge. Once empty, it should be discarded.

? Always carry a spare NovoRapid PumpCart.

Read the usage instructions carefully on how to use NovoRapid PumpCart included in this prospectus.

What to do in case of pump failure

Make sure you have an alternative method for administering insulin subcutaneously (e.g., a syringe) in case the pump fails.

If you use more insulin than you should

If you use too much insulin, your blood sugar level may become very low (hypoglycemia). See a) Summary of severe and very common adverse effects in section 4.

If you forget to use your insulin

If you forget to inject insulin, your blood sugar level may become very high (hyperglycemia). See c) Effects of diabetes in section 4.

If you interrupt your insulin treatment

Do not stop your insulin treatment without consulting your doctor, as this could lead to very high blood sugar levels (severe hyperglycemia) and ketoacidosis. See c) Effects of diabetes in section 4.

If you have any other questions about the use of this medication, ask your doctor, nurse, or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

a)Summary of serious and very frequent side effects

Low blood sugar (hypoglycemia)is a very frequent side effect.It can affect more than 1 in 10people.

Symptoms of low blood sugar may appear if:

•too much insulin is injected;

•not enough food is eaten or a meal is skipped;

•more exercise than usual is done;

•alcohol is consumed (see Alcoholic beverages and use of NovoRapid in section 2).

Warning signs of low blood sugar:chills, cold and pale skin, headache, palpitations, nausea, excessive hunger, temporary changes in vision, drowsiness, fatigue and weakness, nervousness or tremors, anxiety, confusion, and difficulty concentrating.

A severe drop in blood sugar can lead to loss of consciousness. If a severe and prolonged drop in blood sugar is not treated, it can cause brain damage (transient or permanent) and even death. You may regain consciousness more quickly if someone who knows how to do it gives you an injection of glucagon. If you are given glucagon, you should take glucose or a sweet product as soon as you regain consciousness. If you do not respond to glucagon treatment, you should be treated in a hospital.

What to do if your blood sugar level is low:

?If your blood sugar level is low, take glucose tablets or a sweet product (caramels, cookies, fruit juice) and adjust the insulin release or stop the pump. Measure your blood sugar level if possible and then rest.

?Always carry glucose tablets or sweet foods with you, in case you need them.

?When the symptoms of hypoglycemia have disappeared or when the blood sugar levels have stabilized, continue the insulin treatment as usual.

?If you have had blood sugar levels so low that you have lost consciousness, if you have needed someone to give you an injection of glucagon, or if you have had many drops in blood sugar levels, talk to your doctor. You may need to adjust the amount or schedule of insulin, food, or exercise.

Inform others that you have diabetes and what the consequences may be, including the risk of losing consciousness due to a drop in blood sugar. Inform them that if you become unconscious, they should lay you on your side and seek medical help immediately. Do not give you anything to eat or drink, as you may choke.

Severe allergic reactionsto NovoRapid or any of its components (systemic allergic reaction) is a very rare but potentially fatal side effect. It can affect up to 1 in 10,000people.

Consult your doctor immediately:

•if the signs of allergy spread to otherparts of your body.

•if you suddenly feel sick and have sweating, vomiting, difficulty breathing, palpitations, dizziness.

?If you notice any of these symptoms, consult your doctor immediately.

Changes in skin at the injection site: If insulin is injected in the same place, the fatty tissue may shrink (lipatrophy) or become thicker (lipohypertrophy) (this can affect up to 1 in 100 people). Bumps under the skin can also occur due to the accumulation of a protein called amyloid (cutaneous amyloidosis; it is not known how often this occurs). Insulin may not work well if injected in a thickened, shrunk, or swollen area. Change the injection site to help prevent these skin changes.

b)Other side effects list

Frequent side effects

They can affect up to 1 in 100people.

Allergic reactions: may appearlocal allergic reactionsat the injection site (pain, redness, hives, inflammation, hematomas, swelling, and itching). These reactions usually disappear after a few weeks of treatment. If the symptoms do not disappear, or if they spread to your body, consult your doctor immediately. See also Severe allergic reactions above.

Visual problems:starting insulin treatment may cause vision problems, but this alteration is usually temporary.

Joint swelling:starting insulin treatment may cause fluid accumulation, leading to inflammation of the ankles and other joints. This effect usually disappears quickly. If not, consult your doctor.

Diabetic retinopathy(a disease of the eyes related to diabetes that can lead to vision loss):if you have diabetic retinopathy and your blood sugar level improves rapidly, the retinopathy may worsen. Consult your doctor.

Rare side effects

They can affect up to 1 in 1,000people.

Painful neuropathy(pain due to nerve damage):if your blood sugar level improves rapidly, you may experience nerve-related pain. This is called acute painful neuropathy and is usually temporary.

Reporting side effects

If you experience any type of side effect, consult your doctor, nurse, or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

c)Diabetes effects

High blood sugar (hyperglycemia)

Symptoms of high blood sugar may appear if:

•not enough insulin is injected;

•if you forget to inject insulin or interrupt insulin treatment;

•if you repeatedly inject less insulin than you need;

•if you have an infection or fever;

•if you eat more than usual;

•if you do less physical exercise than usual.

Warning signs of high blood sugar:

the warning signs appear gradually. These include: increased need to urinate, thirst, loss of appetite, feeling dizzy (nausea or vomiting), drowsiness or fatigue, dry and red skin, feeling of dryness in the mouth, and breath with a fruity odor (acetone).

What to do if your blood sugar level is high:

?If you notice any of the described symptoms: check your blood sugar level, check the level of ketones in your urine if possible, and consult your doctor immediately.

?These may be symptoms of a very serious condition called diabetic ketoacidosis (acid accumulates in the blood due to the body breaking down fat instead of sugar). If not treated, it can cause diabetic coma and death.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the cartridge label and on the packaging, after CAD. The expiration date is the last day of the month indicated.

Always keep the cartridge in the outer packaging when not in use, to protect it from light. NovoRapid PumpCart must be protected from excessive heat and light during storage and use.

Before opening:The NovoRapid PumpCart that is not in use must be stored in the refrigerator between 2°C and 8°C, away from the walls or the refrigerator's cooling component. Do not freeze.

During use or when carried as a spareTheNovoRapid PumpCart that is in usemust not be stored in the refrigerator. NovoRapid PumpCart carried as a spare may be kept for a maximum of 2weeks below 30ºC. After that, it can be used for a maximum of 7 days below 37ºC in a pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump pumps. Keep NovoRapid PumpCart in the packaging until you use it to protect it from damage. Always protect the cartridge from light during use.

Medications should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of NovoRapid PumpCart

•The active ingredient is insulin aspart. Each ml contains 100 units of insulin aspart. Each cartridge contains 160 units of insulin aspart in 1.6 ml of injectable solution.

•The other components are glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injection.

Appearance of the product and contents of the package

NovoRapid PumpCart is presented as an injection solution.

The package contains 5 cartridges and a multiple pack with 25 cartridges (5 packs of 5 cartridges) of 1.6 ml.It may only be marketed in some package sizes.

The solution is transparent and colorless.

Marketing authorization holder and manufacturer responsible

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark

Please follow the information described in “Instructions for using NovoRapid PumpCart pre-filled cartridge”.

Last review date of this leaflet:03/2023

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for using NovoRapid PumpCart pre-filled cartridge

NovoRapid PumpCart can only be used with an insulin pump designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps. Do not use it with other devices not designed for NovoRapid PumpCart, as this may result in an incorrect dose of insulin and therefore hyper- or hypoglycemia..

Read these instructions carefullybefore using your NovoRapid PumpCart.

Also read the pump manual (user manual)that comes with the insulin pump.

Please pay special attention to these notes as they are important for the safe use of NovoRapid PumpCart.

•Handle the pump and cartridge with care and follow the instructions carefully. Rough handling or misuse may cause incorrect dosing and may result in very high or very low blood sugar levels.

•NovoRapid PumpCart is ready to use directly in the pump.

•NovoRapid PumpCart contains 1.6 ml of insulin aspart solution, equivalent to 160 units.

•This medicine should never be mixed with any other.

•Do not refill NovoRapid PumpCart. Once empty, it should be discarded.

•Always ensure that you have a spare NovoRapid PumpCart available.

•To ensure correct dosing, NovoRapid PumpCart should not be used in a syringe.

•NovoRapid PumpCart should be protected from excessive heat and light during storage and use.

•NovoRapid PumpCart should be kept out of reach of other people, especially children.

1. Before inserting a NovoRapid PumpCart cartridge into your pump

•Take NovoRapid PumpCart to room temperature.

•Remove NovoRapid PumpCart from its package.

•Check the label to ensure it is NovoRapid PumpCart.

•Check the expiration date that appears on the label and the package.

Always check that NovoRapid PumpCart has the appearance it should. See Figure A.

Only the top of the plunger should be visible above the white label band. If you suspect that NovoRapid PumpCart is damaged, return it to your supplier.

Do notuse it if it is damaged, or if it loses insulin or if the plunger has moved, making the bottom of the plunger visible above the white label band. This may mean that the insulin has leaked out.

Check that the insulin NovoRapid PumpCart is transparent and colorless. If the insulin appears cloudy, do not use NovoRapid PumpCart. The cartridge may contain a small amount of air in the form of small bubbles.

2.Insertion of a new NovoRapid PumpCart cartridge into your pump

•Follow the instructions in the pump manual that comes with your pump to insert a new NovoRapid PumpCart cartridge into your pump.

•Insert NovoRapid PumpCart into the cartridge compartment of the pump. The side of the plunger is the first to be inserted.

•Connect the infusion set to NovoRapid PumpCart by connecting the adapter to your pump.

Regularly check for damage to the pump and cartridge, such as cracks or leaks. If you smell insulin, it may indicate a leak. If you observe cracks or leaksdo not usethe cartridge. Follow the instructions in the pump manual to replace the cartridge and to clean the cartridge compartment in the pump. A leak of insulin may cause incorrect dosing and may result in high blood sugar levels. See section 4 c) of the leaflet.

During the day and before going to bed, check that your pump is administering insulin and there are no leaks.You maynot have an alert from the pump as a result of a failure of insulin administration and may not realize there is a problem. You may need to check your blood sugar levels. Consult with your doctor or diabetes care team if you suspect a problem with insulin administration.

Always ensure that you have an alternative method for administering insulin (e.g. a syringe) available in case the pump fails.Seek medical attention if you think you have high blood sugar or diabetic ketoacidosis.

3.Removal of the empty NovoRapid PumpCart cartridge from your pump

•Follow the instructions in the pump manual to remove the empty NovoRapid PumpCart cartridge from your pump.

•Remove the adapter from the infusion set from the empty NovoRapid PumpCart cartridge.

•Discard the empty NovoRapid PumpCart cartridge and the used infusion set as instructed by your doctor or nurse.

•Follow the steps described in sections 1 and 2 to prepare and insert a new NovoRapid PumpCart cartridge into your pump.